Trial Outcomes & Findings for A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02). (NCT NCT02480153)
NCT ID: NCT02480153
Last Updated: 2019-01-23
Results Overview
ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
597 participants
Primary outcome timeframe
Week 12
Results posted on
2019-01-23
Participant Flow
A total of 1231 potential participants were screened after signing an informed consent form, of whom 597 participants were randomized to receive study treatment.
Participant milestones
| Measure |
PF-06410293/PF-06410293/PF-06410293
Period 1 (first dose to Week 26 predose assessments): participants were blindly randomized in a 1:1 ratio to receive PF-06410293 (a biosimilar to Humira) or adalimumab-EU (Humira from European Union) 40 mg every 2 weeks by subcutaneous injection. All participants randomized into PF-06410293 arm continued to receive PF-06410293 in Periods 2 and 3. Period 2 (Week 26 dosing to Week 52 predose assessments): participants from adalimumab-EU arm were blindly re-randomized in a 1:1 ratio to remain on adalimumab-EU or transition to PF-06410293. Period 3 (Week 52 dosing to Week 78 end of treatment visit): all the remaining participants on adalimumab-EU were switched to open-label PF-06410293.
|
Adalimumab-EU/Adalimumab-EU/PF-06410293
Period 1 (first dose to Week 26 predose assessments): participants were blindly randomized in a 1:1 ratio to receive PF-06410293 (a biosimilar to Humira) or adalimumab-EU (Humira from European Union) 40 mg every 2 weeks by subcutaneous injection. All participants randomized into PF-06410293 arm continued to receive PF-06410293 in Periods 2 and 3. Period 2 (Week 26 dosing to Week 52 predose assessments): participants from adalimumab-EU arm were blindly re-randomized in a 1:1 ratio to remain on adalimumab-EU or transition to PF-06410293. Period 3 (Week 52 dosing to Week 78 end of treatment visit): all the remaining participants on adalimumab-EU were switched to open-label PF-06410293.
|
Adalimumab-EU/PF-06410293/PF-06410293
Period 1 (first dose to Week 26 predose assessments): participants were blindly randomized in a 1:1 ratio to receive PF-06410293 (a biosimilar to Humira) or adalimumab-EU (Humira from European Union) 40 mg every 2 weeks by subcutaneous injection. \[This reporting group in Period 1 is a placeholder box only (not part of the 1:1 randomization).\] All participants randomized into PF-06410293 arm continued to receive PF-06410293 in Periods 2 and 3. Period 2 (Week 26 dosing to Week 52 predose assessments): participants from adalimumab-EU arm were blindly re-randomized in a 1:1 ratio to remain on adalimumab-EU or transition to PF-06410293. Period 3 (Week 52 dosing to Week 78 end of treatment visit): all the remaining participants on adalimumab-EU were switched to open-label PF-06410293.
|
|---|---|---|---|
|
Period 1: First Dose to Week 26 Pre-dose
STARTED
|
297
|
300
|
0
|
|
Period 1: First Dose to Week 26 Pre-dose
Received Treatment
|
297
|
299
|
0
|
|
Period 1: First Dose to Week 26 Pre-dose
COMPLETED
|
293
|
284
|
0
|
|
Period 1: First Dose to Week 26 Pre-dose
NOT COMPLETED
|
4
|
16
|
0
|
|
Period 2: Week 26 to Week 52 Pre-dose
STARTED
|
283
|
135
|
134
|
|
Period 2: Week 26 to Week 52 Pre-dose
Received Treatment
|
283
|
135
|
133
|
|
Period 2: Week 26 to Week 52 Pre-dose
COMPLETED
|
263
|
122
|
127
|
|
Period 2: Week 26 to Week 52 Pre-dose
NOT COMPLETED
|
20
|
13
|
7
|
|
Period 3: Week 52 Dosing to Week 78
STARTED
|
259
|
121
|
127
|
|
Period 3: Week 52 Dosing to Week 78
Received Treatment
|
258
|
120
|
127
|
|
Period 3: Week 52 Dosing to Week 78
COMPLETED
|
252
|
118
|
123
|
|
Period 3: Week 52 Dosing to Week 78
NOT COMPLETED
|
7
|
3
|
4
|
Reasons for withdrawal
| Measure |
PF-06410293/PF-06410293/PF-06410293
Period 1 (first dose to Week 26 predose assessments): participants were blindly randomized in a 1:1 ratio to receive PF-06410293 (a biosimilar to Humira) or adalimumab-EU (Humira from European Union) 40 mg every 2 weeks by subcutaneous injection. All participants randomized into PF-06410293 arm continued to receive PF-06410293 in Periods 2 and 3. Period 2 (Week 26 dosing to Week 52 predose assessments): participants from adalimumab-EU arm were blindly re-randomized in a 1:1 ratio to remain on adalimumab-EU or transition to PF-06410293. Period 3 (Week 52 dosing to Week 78 end of treatment visit): all the remaining participants on adalimumab-EU were switched to open-label PF-06410293.
|
Adalimumab-EU/Adalimumab-EU/PF-06410293
Period 1 (first dose to Week 26 predose assessments): participants were blindly randomized in a 1:1 ratio to receive PF-06410293 (a biosimilar to Humira) or adalimumab-EU (Humira from European Union) 40 mg every 2 weeks by subcutaneous injection. All participants randomized into PF-06410293 arm continued to receive PF-06410293 in Periods 2 and 3. Period 2 (Week 26 dosing to Week 52 predose assessments): participants from adalimumab-EU arm were blindly re-randomized in a 1:1 ratio to remain on adalimumab-EU or transition to PF-06410293. Period 3 (Week 52 dosing to Week 78 end of treatment visit): all the remaining participants on adalimumab-EU were switched to open-label PF-06410293.
|
Adalimumab-EU/PF-06410293/PF-06410293
Period 1 (first dose to Week 26 predose assessments): participants were blindly randomized in a 1:1 ratio to receive PF-06410293 (a biosimilar to Humira) or adalimumab-EU (Humira from European Union) 40 mg every 2 weeks by subcutaneous injection. \[This reporting group in Period 1 is a placeholder box only (not part of the 1:1 randomization).\] All participants randomized into PF-06410293 arm continued to receive PF-06410293 in Periods 2 and 3. Period 2 (Week 26 dosing to Week 52 predose assessments): participants from adalimumab-EU arm were blindly re-randomized in a 1:1 ratio to remain on adalimumab-EU or transition to PF-06410293. Period 3 (Week 52 dosing to Week 78 end of treatment visit): all the remaining participants on adalimumab-EU were switched to open-label PF-06410293.
|
|---|---|---|---|
|
Period 1: First Dose to Week 26 Pre-dose
Insufficient Clinical response
|
0
|
1
|
0
|
|
Period 1: First Dose to Week 26 Pre-dose
Non-compliance with study treatment
|
0
|
1
|
0
|
|
Period 1: First Dose to Week 26 Pre-dose
Adverse Event
|
1
|
2
|
0
|
|
Period 1: First Dose to Week 26 Pre-dose
Withdrawal by Subject
|
3
|
8
|
0
|
|
Period 1: First Dose to Week 26 Pre-dose
Other
|
0
|
1
|
0
|
|
Period 1: First Dose to Week 26 Pre-dose
Death
|
0
|
1
|
0
|
|
Period 1: First Dose to Week 26 Pre-dose
Lost to Follow-up
|
0
|
2
|
0
|
|
Period 2: Week 26 to Week 52 Pre-dose
Insufficient clinical response
|
4
|
1
|
3
|
|
Period 2: Week 26 to Week 52 Pre-dose
Non-compliance with study treatment
|
0
|
1
|
0
|
|
Period 2: Week 26 to Week 52 Pre-dose
Withdrawal by Subject
|
8
|
3
|
1
|
|
Period 2: Week 26 to Week 52 Pre-dose
Adverse Event
|
6
|
7
|
3
|
|
Period 2: Week 26 to Week 52 Pre-dose
Other
|
2
|
0
|
0
|
|
Period 2: Week 26 to Week 52 Pre-dose
Lost to Follow-up
|
0
|
1
|
0
|
|
Period 3: Week 52 Dosing to Week 78
Withdrawal by Subject
|
3
|
2
|
1
|
|
Period 3: Week 52 Dosing to Week 78
Lost to Follow-up
|
4
|
0
|
1
|
|
Period 3: Week 52 Dosing to Week 78
Other
|
0
|
0
|
1
|
|
Period 3: Week 52 Dosing to Week 78
Adverse Event
|
0
|
0
|
1
|
|
Period 3: Week 52 Dosing to Week 78
Death
|
0
|
1
|
0
|
Baseline Characteristics
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
Baseline characteristics by cohort
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Total
n=597 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
241 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
470 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
261 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
517 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The Intent-to-Treat (ITT) population (Period 1) was defined as all participants who were randomized to study treatment. Non-responder imputation was applied.
ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1
|
68.35 percentage of participants
|
71.33 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1
Week 2
|
93 Participants
|
96 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1
Week 4
|
154 Participants
|
157 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1
Week 6
|
182 Participants
|
179 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1
Week 8
|
206 Participants
|
204 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1
Week 18
|
232 Participants
|
221 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1
Week 26 (pre-dose)
|
248 Participants
|
234 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2
Week 26
|
245 Participants
|
114 Participants
|
116 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2
Week 30
|
245 Participants
|
111 Participants
|
116 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2
Week 36
|
236 Participants
|
105 Participants
|
118 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2
Week 44
|
233 Participants
|
106 Participants
|
108 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2
Week 52 (pre-dose)
|
234 Participants
|
107 Participants
|
113 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3
Week 52
|
229 Participants
|
106 Participants
|
112 Participants
|
447 Participants
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3
Week 56
|
230 Participants
|
105 Participants
|
106 Participants
|
441 Participants
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3
Week 66
|
226 Participants
|
103 Participants
|
108 Participants
|
437 Participants
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3
Week 76
|
219 Participants
|
95 Participants
|
106 Participants
|
420 Participants
|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3
Week 78
|
216 Participants
|
102 Participants
|
109 Participants
|
427 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
Week 2
|
25 Participants
|
18 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
Week 4
|
53 Participants
|
43 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
Week 6
|
82 Participants
|
82 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
Week 8
|
101 Participants
|
100 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
Week 12
|
118 Participants
|
119 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
Week 18
|
134 Participants
|
141 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
Week 26 (pre-dose)
|
177 Participants
|
164 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2
Week 26
|
175 Participants
|
76 Participants
|
86 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2
Week 30
|
169 Participants
|
67 Participants
|
82 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2
Week 36
|
173 Participants
|
70 Participants
|
94 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2
Week 44
|
182 Participants
|
67 Participants
|
87 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2
Week 52 (pre-dose)
|
178 Participants
|
75 Participants
|
97 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3
Week 52
|
177 Participants
|
74 Participants
|
96 Participants
|
347 Participants
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3
Week 56
|
175 Participants
|
78 Participants
|
94 Participants
|
347 Participants
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3
Week 66
|
177 Participants
|
75 Participants
|
92 Participants
|
344 Participants
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3
Week 76
|
179 Participants
|
66 Participants
|
90 Participants
|
335 Participants
|
|
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3
Week 78
|
185 Participants
|
71 Participants
|
90 Participants
|
346 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
Week 2
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
Week 4
|
11 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
Week 6
|
24 Participants
|
26 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
Week 8
|
37 Participants
|
35 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
Week 12
|
49 Participants
|
57 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
Week 18
|
64 Participants
|
66 Participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
Week 26 (pre-dose)
|
88 Participants
|
93 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2
Week 26
|
88 Participants
|
41 Participants
|
52 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2
Week 30
|
96 Participants
|
41 Participants
|
49 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2
Week 36
|
102 Participants
|
36 Participants
|
59 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2
Week 44
|
109 Participants
|
44 Participants
|
53 Participants
|
—
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2
Week 52 (pre-dose)
|
103 Participants
|
43 Participants
|
59 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3
Week 52
|
103 Participants
|
42 Participants
|
58 Participants
|
203 Participants
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3
Week 56
|
101 Participants
|
42 Participants
|
59 Participants
|
202 Participants
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3
Week 66
|
112 Participants
|
48 Participants
|
60 Participants
|
220 Participants
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3
Week 76
|
118 Participants
|
39 Participants
|
63 Participants
|
220 Participants
|
|
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3
Week 78
|
128 Participants
|
48 Participants
|
69 Participants
|
245 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Tender Joint Count: Period 1
Baseline
|
24.3 joints
Standard Deviation 12.29
|
26.7 joints
Standard Deviation 14.80
|
—
|
—
|
|
Change From Baseline in Tender Joint Count: Period 1
Change at Week 2
|
-7.5 joints
Standard Deviation 9.89
|
-7.1 joints
Standard Deviation 9.14
|
—
|
—
|
|
Change From Baseline in Tender Joint Count: Period 1
Change at Week 4
|
-10.2 joints
Standard Deviation 10.59
|
-10.7 joints
Standard Deviation 9.92
|
—
|
—
|
|
Change From Baseline in Tender Joint Count: Period 1
Change at Week 6
|
-12.8 joints
Standard Deviation 11.28
|
-13.1 joints
Standard Deviation 11.93
|
—
|
—
|
|
Change From Baseline in Tender Joint Count: Period 1
Change at Week 8
|
-14.2 joints
Standard Deviation 11.37
|
-15.2 joints
Standard Deviation 11.84
|
—
|
—
|
|
Change From Baseline in Tender Joint Count: Period 1
Change at Week 12
|
-15.4 joints
Standard Deviation 11.69
|
-16.1 joints
Standard Deviation 12.65
|
—
|
—
|
|
Change From Baseline in Tender Joint Count: Period 1
Change at Week 18
|
-16.8 joints
Standard Deviation 11.42
|
-17.3 joints
Standard Deviation 12.69
|
—
|
—
|
|
Change From Baseline in Tender Joint Count: Period 1
Change at Week 26 (pre-dose)
|
-18.4 joints
Standard Deviation 11.41
|
-19.2 joints
Standard Deviation 12.52
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Tender Joint Count: Period 2
Baseline
|
23.7 joints
Standard Deviation 11.87
|
26.8 joints
Standard Deviation 14.72
|
25.5 joints
Standard Deviation 15.00
|
—
|
|
Change From Baseline in Tender Joint Count: Period 2
Change at Week 26
|
-18.4 joints
Standard Deviation 11.34
|
-20.1 joints
Standard Deviation 12.47
|
-19.3 joints
Standard Deviation 11.99
|
—
|
|
Change From Baseline in Tender Joint Count: Period 2
Change at Week 30
|
-19.0 joints
Standard Deviation 11.85
|
-19.5 joints
Standard Deviation 14.28
|
-19.4 joints
Standard Deviation 12.22
|
—
|
|
Change From Baseline in Tender Joint Count: Period 2
Change at Week 36
|
-18.7 joints
Standard Deviation 12.01
|
-20.1 joints
Standard Deviation 12.62
|
-20.4 joints
Standard Deviation 12.56
|
—
|
|
Change From Baseline in Tender Joint Count: Period 2
Change at Week 44
|
-19.4 joints
Standard Deviation 12.01
|
-21.5 joints
Standard Deviation 13.56
|
-20.2 joints
Standard Deviation 12.94
|
—
|
|
Change From Baseline in Tender Joint Count: Period 2
Change at Week 52 (pre-dose)
|
-18.9 joints
Standard Deviation 11.49
|
-21.0 joints
Standard Deviation 14.14
|
-21.2 joints
Standard Deviation 12.95
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Tender Joint Count: Period 3
Baseline
|
23.8 joints
Standard Deviation 11.89
|
26.5 joints
Standard Deviation 14.97
|
25.4 joints
Standard Deviation 14.77
|
24.9 joints
Standard Deviation 13.45
|
|
Change From Baseline in Tender Joint Count: Period 3
Change at Week 52
|
-19.3 joints
Standard Deviation 11.38
|
-21.2 joints
Standard Deviation 14.13
|
-21.2 joints
Standard Deviation 13.00
|
-20.2 joints
Standard Deviation 12.50
|
|
Change From Baseline in Tender Joint Count: Period 3
Change at Week 56
|
-19.4 joints
Standard Deviation 11.27
|
-21.1 joints
Standard Deviation 13.55
|
-21.6 joints
Standard Deviation 13.43
|
-20.4 joints
Standard Deviation 12.42
|
|
Change From Baseline in Tender Joint Count: Period 3
Change at Week 66
|
-19.5 joints
Standard Deviation 10.97
|
-21.3 joints
Standard Deviation 12.83
|
-21.6 joints
Standard Deviation 13.55
|
-20.5 joints
Standard Deviation 12.12
|
|
Change From Baseline in Tender Joint Count: Period 3
Change at Week 76
|
-20.6 joints
Standard Deviation 11.75
|
-22.0 joints
Standard Deviation 14.06
|
-22.0 joints
Standard Deviation 14.00
|
-21.3 joints
Standard Deviation 12.89
|
|
Change From Baseline in Tender Joint Count: Period 3
Change at Week 78
|
-20.5 joints
Standard Deviation 11.53
|
-21.1 joints
Standard Deviation 13.23
|
-22.1 joints
Standard Deviation 14.26
|
-21.1 joints
Standard Deviation 12.67
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count: Period 1
Baseline
|
15.4 joints
Standard Deviation 7.81
|
17.0 joints
Standard Deviation 9.86
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 1
Change at Week 2
|
-5.7 joints
Standard Deviation 6.31
|
-6.1 joints
Standard Deviation 7.23
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 1
Change at Week 4
|
-7.7 joints
Standard Deviation 7.04
|
-8.2 joints
Standard Deviation 8.38
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 1
Change at Week 6
|
-9.0 joints
Standard Deviation 7.37
|
-9.7 joints
Standard Deviation 8.97
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 1
Change at Week 8
|
-9.8 joints
Standard Deviation 7.06
|
-11.0 joints
Standard Deviation 8.50
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 1
Change at Week 12
|
-10.4 joints
Standard Deviation 7.38
|
-11.8 joints
Standard Deviation 8.87
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 1
Change at Week 18
|
-11.3 joints
Standard Deviation 6.76
|
-13.0 joints
Standard Deviation 9.45
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 1
Change at Week 26 (pre-dose)
|
-12.2 joints
Standard Deviation 7.18
|
-13.6 joints
Standard Deviation 9.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count: Period 2
Baseline
|
15.1 joints
Standard Deviation 7.66
|
17.1 joints
Standard Deviation 9.60
|
17.0 joints
Standard Deviation 10.31
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 2
Change at Week 26
|
-12.2 joints
Standard Deviation 7.11
|
-13.6 joints
Standard Deviation 8.15
|
-14.3 joints
Standard Deviation 9.84
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 2
Change at Week 30
|
-12.3 joints
Standard Deviation 7.58
|
-13.3 joints
Standard Deviation 9.31
|
-14.3 joints
Standard Deviation 9.70
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 2
Change at Week 36
|
-12.4 joints
Standard Deviation 7.76
|
-14.2 joints
Standard Deviation 8.74
|
-14.6 joints
Standard Deviation 9.69
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 2
Change at Week 44
|
-12.8 joints
Standard Deviation 7.12
|
-14.7 joints
Standard Deviation 8.87
|
-14.8 joints
Standard Deviation 9.97
|
—
|
|
Change From Baseline in Swollen Joint Count: Period 2
Change at Week 52 (pre-dose)
|
-12.6 joints
Standard Deviation 6.92
|
-14.2 joints
Standard Deviation 8.29
|
-15.2 joints
Standard Deviation 9.82
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count: Period 3
Change at Week 78
|
-13.4 joints
Standard Deviation 7.25
|
-15.0 joints
Standard Deviation 9.35
|
-15.1 joints
Standard Deviation 10.24
|
-14.2 joints
Standard Deviation 8.63
|
|
Change From Baseline in Swollen Joint Count: Period 3
Baseline
|
15.0 joints
Standard Deviation 7.59
|
17.3 joints
Standard Deviation 9.77
|
16.8 joints
Standard Deviation 10.07
|
16.0 joints
Standard Deviation 8.85
|
|
Change From Baseline in Swollen Joint Count: Period 3
Change at Week 52
|
-12.8 joints
Standard Deviation 6.87
|
-14.4 joints
Standard Deviation 8.22
|
-15.2 joints
Standard Deviation 9.75
|
-13.7 joints
Standard Deviation 8.05
|
|
Change From Baseline in Swollen Joint Count: Period 3
Change at Week 56
|
-12.9 joints
Standard Deviation 6.61
|
-14.5 joints
Standard Deviation 8.65
|
-14.9 joints
Standard Deviation 9.65
|
-13.8 joints
Standard Deviation 8.00
|
|
Change From Baseline in Swollen Joint Count: Period 3
Change at Week 66
|
-13.0 joints
Standard Deviation 7.09
|
-14.9 joints
Standard Deviation 8.37
|
-15.2 joints
Standard Deviation 9.92
|
-14.0 joints
Standard Deviation 8.23
|
|
Change From Baseline in Swollen Joint Count: Period 3
Change at Week 76
|
-13.3 joints
Standard Deviation 7.12
|
-14.9 joints
Standard Deviation 8.86
|
-15.1 joints
Standard Deviation 10.27
|
-14.1 joints
Standard Deviation 8.44
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
Change at Week 6
|
-32.6 units on a scale
Standard Deviation 21.72
|
-33.0 units on a scale
Standard Deviation 19.87
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
Baseline
|
65.0 units on a scale
Standard Deviation 15.22
|
66.7 units on a scale
Standard Deviation 15.80
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
Change at Week 2
|
-20.7 units on a scale
Standard Deviation 18.62
|
-20.5 units on a scale
Standard Deviation 18.87
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
Change at Week 4
|
-28.9 units on a scale
Standard Deviation 20.24
|
-29.0 units on a scale
Standard Deviation 18.29
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
Change at Week 8
|
-35.6 units on a scale
Standard Deviation 20.86
|
-37.1 units on a scale
Standard Deviation 18.97
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
Change at Week 12
|
-40.4 units on a scale
Standard Deviation 19.01
|
-40.5 units on a scale
Standard Deviation 19.45
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
Change at Week 18
|
-44.2 units on a scale
Standard Deviation 18.96
|
-44.2 units on a scale
Standard Deviation 19.64
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
Change at Week 26 (pre-dose)
|
-47.2 units on a scale
Standard Deviation 18.68
|
-46.5 units on a scale
Standard Deviation 19.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2
Baseline
|
64.9 units on a scale
Standard Deviation 15.21
|
66.3 units on a scale
Standard Deviation 15.34
|
67.0 units on a scale
Standard Deviation 15.56
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2
Change at Week 26
|
-47.7 units on a scale
Standard Deviation 18.09
|
-45.5 units on a scale
Standard Deviation 19.80
|
-49.2 units on a scale
Standard Deviation 18.77
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2
Change at Week 30
|
-47.9 units on a scale
Standard Deviation 20.02
|
-46.5 units on a scale
Standard Deviation 19.52
|
-49.6 units on a scale
Standard Deviation 18.53
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2
Change at Week 36
|
-47.3 units on a scale
Standard Deviation 20.22
|
-45.4 units on a scale
Standard Deviation 19.46
|
-49.5 units on a scale
Standard Deviation 20.47
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2
Change at Week 44
|
-49.1 units on a scale
Standard Deviation 18.34
|
-46.9 units on a scale
Standard Deviation 20.16
|
-50.5 units on a scale
Standard Deviation 20.50
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2
Change at Week 52 (pre-dose)
|
-47.9 units on a scale
Standard Deviation 18.89
|
-48.4 units on a scale
Standard Deviation 17.75
|
-52.1 units on a scale
Standard Deviation 20.01
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3
Baseline
|
65.4 units on a scale
Standard Deviation 14.57
|
66.4 units on a scale
Standard Deviation 15.55
|
67.0 units on a scale
Standard Deviation 15.73
|
66.1 units on a scale
Standard Deviation 15.09
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3
Change at Week 52
|
-48.9 units on a scale
Standard Deviation 17.82
|
-48.5 units on a scale
Standard Deviation 17.87
|
-52.2 units on a scale
Standard Deviation 19.62
|
-49.7 units on a scale
Standard Deviation 18.33
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3
Change at Week 56
|
-50.5 units on a scale
Standard Deviation 16.95
|
-47.7 units on a scale
Standard Deviation 20.00
|
-51.6 units on a scale
Standard Deviation 21.18
|
-50.1 units on a scale
Standard Deviation 18.85
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3
Change at Week 66
|
-49.4 units on a scale
Standard Deviation 18.93
|
-49.1 units on a scale
Standard Deviation 18.21
|
-51.1 units on a scale
Standard Deviation 20.29
|
-49.8 units on a scale
Standard Deviation 19.09
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3
Change at Week 76
|
-50.9 units on a scale
Standard Deviation 17.87
|
-49.7 units on a scale
Standard Deviation 21.07
|
-52.3 units on a scale
Standard Deviation 20.57
|
-51.0 units on a scale
Standard Deviation 19.33
|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3
Change at Week 78
|
-52.3 units on a scale
Standard Deviation 17.40
|
-50.8 units on a scale
Standard Deviation 19.42
|
-52.5 units on a scale
Standard Deviation 19.96
|
-52.0 units on a scale
Standard Deviation 18.55
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
Baseline
|
63.7 units on a scale
Standard Deviation 18.42
|
65.9 units on a scale
Standard Deviation 19.61
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
Change at Week 2
|
-13.1 units on a scale
Standard Deviation 18.59
|
-13.9 units on a scale
Standard Deviation 18.72
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
Change at Week 4
|
-18.5 units on a scale
Standard Deviation 20.35
|
-17.4 units on a scale
Standard Deviation 20.30
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
Change at Week 6
|
-21.9 units on a scale
Standard Deviation 21.92
|
-21.7 units on a scale
Standard Deviation 22.49
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
Change at Week 8
|
-24.8 units on a scale
Standard Deviation 24.06
|
-25.5 units on a scale
Standard Deviation 23.18
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
Change at Week 12
|
-28.8 units on a scale
Standard Deviation 24.80
|
-28.5 units on a scale
Standard Deviation 23.91
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
Change at Week 18
|
-31.5 units on a scale
Standard Deviation 23.69
|
-31.4 units on a scale
Standard Deviation 25.48
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
Change at Week 26 (pre-dose)
|
-35.1 units on a scale
Standard Deviation 24.62
|
-33.5 units on a scale
Standard Deviation 26.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2
Baseline
|
63.5 units on a scale
Standard Deviation 18.04
|
65.6 units on a scale
Standard Deviation 19.91
|
64.4 units on a scale
Standard Deviation 19.37
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2
Change at Week 26
|
-35.4 units on a scale
Standard Deviation 23.87
|
-32.4 units on a scale
Standard Deviation 25.68
|
-36.0 units on a scale
Standard Deviation 26.04
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2
Change at Week 30
|
-36.3 units on a scale
Standard Deviation 24.86
|
-34.1 units on a scale
Standard Deviation 26.40
|
-37.6 units on a scale
Standard Deviation 24.47
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2
Change at Week 36
|
-35.5 units on a scale
Standard Deviation 25.87
|
-34.9 units on a scale
Standard Deviation 25.74
|
-39.4 units on a scale
Standard Deviation 24.87
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2
Change at Week 44
|
-38.6 units on a scale
Standard Deviation 25.03
|
-35.7 units on a scale
Standard Deviation 26.16
|
-38.3 units on a scale
Standard Deviation 28.05
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2
Change at Week 52 (pre-dose)
|
-37.4 units on a scale
Standard Deviation 25.09
|
-36.8 units on a scale
Standard Deviation 24.05
|
-40.6 units on a scale
Standard Deviation 24.16
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3
Baseline
|
63.5 units on a scale
Standard Deviation 17.99
|
66.3 units on a scale
Standard Deviation 19.98
|
64.5 units on a scale
Standard Deviation 19.05
|
64.4 units on a scale
Standard Deviation 18.75
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3
Change at Week 52
|
-38.1 units on a scale
Standard Deviation 25.06
|
-37.3 units on a scale
Standard Deviation 23.93
|
-40.6 units on a scale
Standard Deviation 23.96
|
-38.5 units on a scale
Standard Deviation 24.50
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3
Change at Week 56
|
-39.1 units on a scale
Standard Deviation 23.87
|
-37.7 units on a scale
Standard Deviation 25.07
|
-40.1 units on a scale
Standard Deviation 25.62
|
-39.0 units on a scale
Standard Deviation 24.57
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3
Change at Week 66
|
-39.8 units on a scale
Standard Deviation 24.74
|
-39.2 units on a scale
Standard Deviation 24.76
|
-40.7 units on a scale
Standard Deviation 26.42
|
-39.9 units on a scale
Standard Deviation 25.13
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3
Change at Week 76
|
-41.3 units on a scale
Standard Deviation 25.60
|
-39.3 units on a scale
Standard Deviation 25.95
|
-42.4 units on a scale
Standard Deviation 25.68
|
-41.1 units on a scale
Standard Deviation 25.67
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3
Change at Week 78
|
-43.7 units on a scale
Standard Deviation 25.17
|
-41.4 units on a scale
Standard Deviation 25.04
|
-42.7 units on a scale
Standard Deviation 26.09
|
-42.9 units on a scale
Standard Deviation 25.34
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
Baseline
|
64.4 units on a scale
Standard Deviation 19.32
|
68.1 units on a scale
Standard Deviation 19.49
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
Change at Week 2
|
-13.8 units on a scale
Standard Deviation 19.03
|
-16.3 units on a scale
Standard Deviation 18.30
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
Change at Week 4
|
-19.7 units on a scale
Standard Deviation 20.85
|
-21.2 units on a scale
Standard Deviation 21.62
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
Change at Week 6
|
-22.2 units on a scale
Standard Deviation 22.96
|
-23.4 units on a scale
Standard Deviation 22.69
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
Change at Week 8
|
-25.8 units on a scale
Standard Deviation 24.01
|
-28.4 units on a scale
Standard Deviation 23.17
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
Change at Week 12
|
-29.3 units on a scale
Standard Deviation 24.72
|
-31.5 units on a scale
Standard Deviation 24.36
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
Change at Week 18
|
-32.2 units on a scale
Standard Deviation 24.57
|
-34.2 units on a scale
Standard Deviation 25.94
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
Change at Week 26 (pre-dose)
|
-36.2 units on a scale
Standard Deviation 25.16
|
-36.3 units on a scale
Standard Deviation 26.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2
Baseline
|
64.2 units on a scale
Standard Deviation 19.05
|
67.5 units on a scale
Standard Deviation 21.02
|
67.8 units on a scale
Standard Deviation 17.59
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2
Change at Week 26
|
-36.3 units on a scale
Standard Deviation 24.47
|
-35.3 units on a scale
Standard Deviation 26.02
|
-38.8 units on a scale
Standard Deviation 25.71
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2
Change at Week 30
|
-36.7 units on a scale
Standard Deviation 26.11
|
-35.5 units on a scale
Standard Deviation 27.02
|
-41.2 units on a scale
Standard Deviation 22.34
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2
Change at Week 36
|
-36.4 units on a scale
Standard Deviation 26.51
|
-36.0 units on a scale
Standard Deviation 26.30
|
-43.1 units on a scale
Standard Deviation 22.31
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2
Change at Week 44
|
-39.4 units on a scale
Standard Deviation 25.01
|
-36.7 units on a scale
Standard Deviation 25.43
|
-40.6 units on a scale
Standard Deviation 26.49
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2
Change at Week 52 (pre-dose)
|
-37.5 units on a scale
Standard Deviation 25.88
|
-38.6 units on a scale
Standard Deviation 24.97
|
-44.0 units on a scale
Standard Deviation 22.94
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3
Change at Week 78
|
-43.8 units on a scale
Standard Deviation 26.05
|
-42.0 units on a scale
Standard Deviation 25.09
|
-45.4 units on a scale
Standard Deviation 24.61
|
-43.8 units on a scale
Standard Deviation 25.44
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3
Baseline
|
64.1 units on a scale
Standard Deviation 19.02
|
67.5 units on a scale
Standard Deviation 21.04
|
68.1 units on a scale
Standard Deviation 17.30
|
65.9 units on a scale
Standard Deviation 19.17
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3
Change at Week 52
|
-38.3 units on a scale
Standard Deviation 25.54
|
-39.0 units on a scale
Standard Deviation 24.94
|
-43.9 units on a scale
Standard Deviation 22.79
|
-39.9 units on a scale
Standard Deviation 24.80
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3
Change at Week 56
|
-39.7 units on a scale
Standard Deviation 24.47
|
-39.1 units on a scale
Standard Deviation 25.61
|
-43.4 units on a scale
Standard Deviation 25.16
|
-40.5 units on a scale
Standard Deviation 24.93
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3
Change at Week 66
|
-40.6 units on a scale
Standard Deviation 25.04
|
-39.7 units on a scale
Standard Deviation 24.43
|
-43.3 units on a scale
Standard Deviation 26.63
|
-41.1 units on a scale
Standard Deviation 25.29
|
|
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3
Change at Week 76
|
-41.7 units on a scale
Standard Deviation 26.94
|
-40.5 units on a scale
Standard Deviation 26.56
|
-45.3 units on a scale
Standard Deviation 23.51
|
-42.3 units on a scale
Standard Deviation 26.05
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
Baseline
|
1.519 units on a scale
Standard Deviation 0.6009
|
1.673 units on a scale
Standard Deviation 0.6378
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
Change at Week 2
|
-0.254 units on a scale
Standard Deviation 0.4018
|
-0.288 units on a scale
Standard Deviation 0.4383
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
Change at Week 4
|
-0.338 units on a scale
Standard Deviation 0.4720
|
-0.375 units on a scale
Standard Deviation 0.4555
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
Change at Week 6
|
-0.426 units on a scale
Standard Deviation 0.5114
|
-0.454 units on a scale
Standard Deviation 0.5350
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
Change at Week 8
|
-0.480 units on a scale
Standard Deviation 0.5253
|
-0.520 units on a scale
Standard Deviation 0.5457
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
Change at Week 12
|
-0.530 units on a scale
Standard Deviation 0.5218
|
-0.543 units on a scale
Standard Deviation 0.5882
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
Change at Week 18
|
-0.583 units on a scale
Standard Deviation 0.5704
|
-0.630 units on a scale
Standard Deviation 0.6344
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
Change at Week 26 (pre-dose)
|
-0.654 units on a scale
Standard Deviation 0.6262
|
-0.674 units on a scale
Standard Deviation 0.6618
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2
Baseline
|
1.514 units on a scale
Standard Deviation 0.5920
|
1.639 units on a scale
Standard Deviation 0.6677
|
1.666 units on a scale
Standard Deviation 0.6271
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2
Change at Week 26
|
-0.658 units on a scale
Standard Deviation 0.6250
|
-0.652 units on a scale
Standard Deviation 0.6293
|
-0.723 units on a scale
Standard Deviation 0.6763
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2
Change at Week 30
|
-0.681 units on a scale
Standard Deviation 0.6379
|
-0.650 units on a scale
Standard Deviation 0.6673
|
-0.772 units on a scale
Standard Deviation 0.7113
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2
Change at Week 36
|
-0.711 units on a scale
Standard Deviation 0.6585
|
-0.662 units on a scale
Standard Deviation 0.6610
|
-0.811 units on a scale
Standard Deviation 0.7048
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2
Change at Week 44
|
-0.726 units on a scale
Standard Deviation 0.6605
|
-0.690 units on a scale
Standard Deviation 0.6414
|
-0.834 units on a scale
Standard Deviation 0.6956
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2
Change at Week 52 (pre-dose)
|
-0.700 units on a scale
Standard Deviation 0.6776
|
-0.729 units on a scale
Standard Deviation 0.6359
|
-0.840 units on a scale
Standard Deviation 0.6861
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3
Baseline
|
1.528 units on a scale
Standard Deviation 0.5941
|
1.632 units on a scale
Standard Deviation 0.6711
|
1.684 units on a scale
Standard Deviation 0.6164
|
1.592 units on a scale
Standard Deviation 0.6212
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3
Change at Week 52
|
-0.719 units on a scale
Standard Deviation 0.6809
|
-0.737 units on a scale
Standard Deviation 0.6379
|
-0.836 units on a scale
Standard Deviation 0.6877
|
-0.752 units on a scale
Standard Deviation 0.6731
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3
Change at Week 56
|
-0.735 units on a scale
Standard Deviation 0.6733
|
-0.754 units on a scale
Standard Deviation 0.6149
|
-0.801 units on a scale
Standard Deviation 0.6549
|
-0.756 units on a scale
Standard Deviation 0.6543
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3
Change at Week 66
|
-0.731 units on a scale
Standard Deviation 0.6656
|
-0.731 units on a scale
Standard Deviation 0.6493
|
-0.828 units on a scale
Standard Deviation 0.6872
|
-0.755 units on a scale
Standard Deviation 0.6672
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3
Change at Week 76
|
-0.751 units on a scale
Standard Deviation 0.6725
|
-0.789 units on a scale
Standard Deviation 0.7225
|
-0.867 units on a scale
Standard Deviation 0.7066
|
-0.788 units on a scale
Standard Deviation 0.6931
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3
Change at Week 78
|
-0.781 units on a scale
Standard Deviation 0.6571
|
-0.800 units on a scale
Standard Deviation 0.7240
|
-0.881 units on a scale
Standard Deviation 0.7194
|
-0.811 units on a scale
Standard Deviation 0.6894
|
SECONDARY outcome
Timeframe: Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Baseline
|
21.3 mg/L
Standard Deviation 22.69
|
22.8 mg/L
Standard Deviation 25.26
|
—
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Change at Week 1
|
-12.6 mg/L
Standard Deviation 19.84
|
-13.4 mg/L
Standard Deviation 24.83
|
—
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Change at Week 2
|
-11.5 mg/L
Standard Deviation 19.10
|
-13.1 mg/L
Standard Deviation 20.74
|
—
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Change at Week 4
|
-11.2 mg/L
Standard Deviation 19.94
|
-12.6 mg/L
Standard Deviation 23.16
|
—
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Change at Week 6
|
-11.3 mg/L
Standard Deviation 18.73
|
-12.6 mg/L
Standard Deviation 24.74
|
—
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Change at Week 8
|
-9.1 mg/L
Standard Deviation 22.65
|
-12.0 mg/L
Standard Deviation 25.68
|
—
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Change at Week 12
|
-9.5 mg/L
Standard Deviation 22.81
|
-12.2 mg/L
Standard Deviation 25.59
|
—
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Change at Week 18
|
-11.4 mg/L
Standard Deviation 20.67
|
-12.3 mg/L
Standard Deviation 26.93
|
—
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
Change at Week 26 (pre-dose)
|
-11.1 mg/L
Standard Deviation 21.92
|
-13.6 mg/L
Standard Deviation 26.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2
Baseline
|
21.2 mg/L
Standard Deviation 22.47
|
22.0 mg/L
Standard Deviation 24.51
|
22.3 mg/L
Standard Deviation 25.93
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2
Change at Week 26
|
-11.3 mg/L
Standard Deviation 21.70
|
-11.2 mg/L
Standard Deviation 27.76
|
-15.8 mg/L
Standard Deviation 25.10
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2
Change at Week 30
|
-11.3 mg/L
Standard Deviation 19.76
|
-10.4 mg/L
Standard Deviation 26.85
|
-15.0 mg/L
Standard Deviation 24.50
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2
Change at Week 36
|
-10.6 mg/L
Standard Deviation 22.58
|
-11.8 mg/L
Standard Deviation 25.41
|
-12.5 mg/L
Standard Deviation 30.36
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2
Change at Week 44
|
-9.9 mg/L
Standard Deviation 22.08
|
-11.1 mg/L
Standard Deviation 27.01
|
-14.8 mg/L
Standard Deviation 26.80
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2
Change at Week 52 (pre-dose)
|
-10.6 mg/L
Standard Deviation 20.84
|
-11.8 mg/L
Standard Deviation 23.85
|
-12.8 mg/L
Standard Deviation 28.49
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3
Baseline
|
20.4 mg/L
Standard Deviation 20.43
|
22.3 mg/L
Standard Deviation 25.30
|
22.7 mg/L
Standard Deviation 26.49
|
21.4 mg/L
Standard Deviation 23.25
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3
Change at Week 52
|
-10.7 mg/L
Standard Deviation 20.81
|
-11.9 mg/L
Standard Deviation 24.04
|
-12.9 mg/L
Standard Deviation 28.57
|
-11.5 mg/L
Standard Deviation 23.70
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3
Change at Week 56
|
-9.9 mg/L
Standard Deviation 25.29
|
-11.7 mg/L
Standard Deviation 26.66
|
-14.3 mg/L
Standard Deviation 26.64
|
-11.4 mg/L
Standard Deviation 25.97
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3
Change at Week 66
|
-11.1 mg/L
Standard Deviation 21.24
|
-9.1 mg/L
Standard Deviation 25.83
|
-13.2 mg/L
Standard Deviation 26.97
|
-11.2 mg/L
Standard Deviation 23.87
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3
Change at Week 76
|
-12.1 mg/L
Standard Deviation 20.58
|
-9.8 mg/L
Standard Deviation 22.03
|
-11.9 mg/L
Standard Deviation 28.83
|
-11.5 mg/L
Standard Deviation 23.15
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3
Change at Week 78
|
-9.7 mg/L
Standard Deviation 24.68
|
-11.9 mg/L
Standard Deviation 22.90
|
-13.3 mg/L
Standard Deviation 27.06
|
-11.1 mg/L
Standard Deviation 24.90
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
Baseline
|
5.9 units on a scale
Standard Deviation 0.87
|
6.1 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
Change at Week 2
|
-1.2 units on a scale
Standard Deviation 0.91
|
-1.1 units on a scale
Standard Deviation 0.92
|
—
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
Change at Week 4
|
-1.5 units on a scale
Standard Deviation 1.00
|
-1.6 units on a scale
Standard Deviation 1.01
|
—
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
Change at Week 6
|
-1.9 units on a scale
Standard Deviation 1.19
|
-1.9 units on a scale
Standard Deviation 1.22
|
—
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
Change at Week 8
|
-2.0 units on a scale
Standard Deviation 1.19
|
-2.2 units on a scale
Standard Deviation 1.22
|
—
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
Change at Week 12
|
-2.2 units on a scale
Standard Deviation 1.20
|
-2.3 units on a scale
Standard Deviation 1.26
|
—
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
Change at Week 18
|
-2.5 units on a scale
Standard Deviation 1.20
|
-2.6 units on a scale
Standard Deviation 1.33
|
—
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
Change at Week 26 (pre-dose)
|
-2.7 units on a scale
Standard Deviation 1.18
|
-2.8 units on a scale
Standard Deviation 1.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2
Baseline
|
5.9 units on a scale
Standard Deviation 0.85
|
6.1 units on a scale
Standard Deviation 0.85
|
6.0 units on a scale
Standard Deviation 0.98
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2
Change at Week 26
|
-2.7 units on a scale
Standard Deviation 1.16
|
-2.7 units on a scale
Standard Deviation 1.28
|
-3.0 units on a scale
Standard Deviation 1.25
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2
Change at Week 30
|
-2.8 units on a scale
Standard Deviation 1.25
|
-2.7 units on a scale
Standard Deviation 1.31
|
-3.1 units on a scale
Standard Deviation 1.17
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2
Change at Week 36
|
-2.8 units on a scale
Standard Deviation 1.29
|
-2.8 units on a scale
Standard Deviation 1.32
|
-3.1 units on a scale
Standard Deviation 1.20
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2
Change at Week 44
|
-3.0 units on a scale
Standard Deviation 1.14
|
-2.9 units on a scale
Standard Deviation 1.26
|
-3.2 units on a scale
Standard Deviation 1.21
|
—
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2
Change at Week 52 (pre-dose)
|
-2.9 units on a scale
Standard Deviation 1.23
|
-2.9 units on a scale
Standard Deviation 1.33
|
-3.3 units on a scale
Standard Deviation 1.26
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3
Baseline
|
5.9 units on a scale
Standard Deviation 0.86
|
6.1 units on a scale
Standard Deviation 0.86
|
6.0 units on a scale
Standard Deviation 0.96
|
6.0 units on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3
Change at Week 52
|
-2.9 units on a scale
Standard Deviation 1.21
|
-2.9 units on a scale
Standard Deviation 1.32
|
-3.3 units on a scale
Standard Deviation 1.25
|
-3.0 units on a scale
Standard Deviation 1.26
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3
Change at Week 56
|
-3.0 units on a scale
Standard Deviation 1.22
|
-2.9 units on a scale
Standard Deviation 1.34
|
-3.3 units on a scale
Standard Deviation 1.29
|
-3.0 units on a scale
Standard Deviation 1.27
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3
Change at Week 66
|
-3.0 units on a scale
Standard Deviation 1.19
|
-3.0 units on a scale
Standard Deviation 1.34
|
-3.3 units on a scale
Standard Deviation 1.26
|
-3.1 units on a scale
Standard Deviation 1.24
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3
Change at Week 76
|
-3.1 units on a scale
Standard Deviation 1.18
|
-3.0 units on a scale
Standard Deviation 1.34
|
-3.4 units on a scale
Standard Deviation 1.29
|
-3.2 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3
Change at Week 78
|
-3.2 units on a scale
Standard Deviation 1.21
|
-3.1 units on a scale
Standard Deviation 1.37
|
-3.4 units on a scale
Standard Deviation 1.39
|
-3.2 units on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline \>1.2 and DAS28 =\<3.2. Moderate response was achieved if DAS28 improvement from baseline \>0.6 to =\<1.2 and DAS28 =\<5.1; or DAS improvement from baseline \>1.2 and DAS28 \>3.2. No response was achieved if DAS improvement from baseline =\<0.6 (no matter present DAS28 score); or DAS improvement from baseline \>0.6 to =\<1.2 and DAS28 \>5.1.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 2 · Good response
|
18 Participants
|
20 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 2 · Moderate response
|
161 Participants
|
136 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 2 · No response
|
110 Participants
|
133 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 4 · Good response
|
48 Participants
|
42 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 4 · Moderate response
|
173 Participants
|
168 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 4 · No response
|
71 Participants
|
81 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 6 · Good response
|
69 Participants
|
65 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 6 · Moderate response
|
178 Participants
|
173 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 6 · No response
|
48 Participants
|
55 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 8 · Good response
|
93 Participants
|
89 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 8 · Moderate response
|
160 Participants
|
160 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 8 · No response
|
38 Participants
|
43 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 12 · Good response
|
104 Participants
|
107 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 12 · Moderate response
|
149 Participants
|
149 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 12 · No response
|
37 Participants
|
37 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 18 · Good response
|
137 Participants
|
132 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 18 · Moderate response
|
134 Participants
|
125 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 18 · No response
|
21 Participants
|
29 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 26 (pre-dose) · Good response
|
162 Participants
|
147 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 26 (pre-dose) · Moderate response
|
110 Participants
|
102 Participants
|
—
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
Week 26 (pre-dose) · No response
|
16 Participants
|
27 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline \>1.2 and DAS28 =\<3.2. Moderate response was achieved if DAS28 improvement from baseline \>0.6 to =\<1.2 and DAS28 =\<5.1; or DAS improvement from baseline \>1.2 and DAS28 \>3.2. No response was achieved if DAS improvement from baseline =\<0.6 (no matter present DAS28 score); or DAS improvement from baseline \>0.6 to =\<1.2 and DAS28 \>5.1.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 26 · Good response
|
161 Participants
|
67 Participants
|
80 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 26 · Moderate response
|
109 Participants
|
53 Participants
|
45 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 26 · No response
|
13 Participants
|
13 Participants
|
9 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 30 · Good response
|
160 Participants
|
64 Participants
|
83 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 30 · Moderate response
|
106 Participants
|
54 Participants
|
45 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 30 · No response
|
13 Participants
|
12 Participants
|
3 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 36 · Good response
|
158 Participants
|
59 Participants
|
86 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 36 · Moderate response
|
97 Participants
|
60 Participants
|
39 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 36 · No response
|
19 Participants
|
7 Participants
|
5 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 44 · Good response
|
170 Participants
|
62 Participants
|
83 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 44 · Moderate response
|
92 Participants
|
60 Participants
|
45 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 44 · No response
|
5 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 52 (pre-dose) · Good response
|
169 Participants
|
61 Participants
|
85 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 52 (pre-dose) · Moderate response
|
86 Participants
|
54 Participants
|
40 Participants
|
—
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
Week 52 (pre-dose) · No response
|
12 Participants
|
8 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline \>1.2 and DAS28 =\<3.2. Moderate response was achieved if DAS28 improvement from baseline \>0.6 to =\<1.2 and DAS28 =\<5.1; or DAS improvement from baseline \>1.2 and DAS28 \>3.2. No response was achieved if DAS improvement from baseline =\<0.6 (no matter present DAS28 score); or DAS improvement from baseline \>0.6 to =\<1.2 and DAS28 \>5.1.
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 52 · Good response
|
169 Participants
|
60 Participants
|
85 Participants
|
314 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 52 · Moderate response
|
80 Participants
|
53 Participants
|
39 Participants
|
172 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 52 · No response
|
9 Participants
|
8 Participants
|
2 Participants
|
19 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 56 · Good response
|
171 Participants
|
63 Participants
|
84 Participants
|
318 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 56 · Moderate response
|
72 Participants
|
50 Participants
|
36 Participants
|
158 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 56 · No response
|
12 Participants
|
8 Participants
|
4 Participants
|
24 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 66 · Good response
|
174 Participants
|
62 Participants
|
86 Participants
|
322 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 66 · Moderate response
|
69 Participants
|
48 Participants
|
33 Participants
|
150 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 66 · No response
|
10 Participants
|
6 Participants
|
3 Participants
|
19 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 76 · Good response
|
170 Participants
|
59 Participants
|
81 Participants
|
310 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 76 · Moderate response
|
64 Participants
|
45 Participants
|
27 Participants
|
136 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 76 · No response
|
7 Participants
|
5 Participants
|
5 Participants
|
17 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 78 · Good response
|
167 Participants
|
67 Participants
|
89 Participants
|
323 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 78 · Moderate response
|
65 Participants
|
40 Participants
|
26 Participants
|
131 Participants
|
|
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Week 78 · No response
|
7 Participants
|
6 Participants
|
5 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) \<2.6 indicates remission.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Baseline
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Week 2
|
9 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Week 4
|
20 Participants
|
17 Participants
|
—
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Week 6
|
35 Participants
|
34 Participants
|
—
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Week 8
|
49 Participants
|
48 Participants
|
—
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Week 12
|
63 Participants
|
62 Participants
|
—
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Week 18
|
71 Participants
|
81 Participants
|
—
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Week 26 (pre-dose)
|
87 Participants
|
99 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) \<2.6 indicates remission.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2
Week 26
|
86 Participants
|
41 Participants
|
58 Participants
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2
Week 30
|
96 Participants
|
42 Participants
|
51 Participants
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2
Week 36
|
106 Participants
|
41 Participants
|
54 Participants
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2
Week 44
|
109 Participants
|
44 Participants
|
51 Participants
|
—
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2
Week 52 (pre-dose)
|
107 Participants
|
40 Participants
|
59 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) \<2.6 indicates remission.
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3
Week 52
|
107 Participants
|
39 Participants
|
59 Participants
|
205 Participants
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3
Week 56
|
111 Participants
|
46 Participants
|
57 Participants
|
214 Participants
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3
Week 66
|
108 Participants
|
52 Participants
|
61 Participants
|
221 Participants
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3
Week 76
|
122 Participants
|
45 Participants
|
60 Participants
|
227 Participants
|
|
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3
Week 78
|
130 Participants
|
51 Participants
|
68 Participants
|
249 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.
Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =\<1; or the score on the simplified disease activity index (SDAI) was =\<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=300 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1
Week 26 (pre-dose)
|
38 Participants
|
44 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1
Week 2
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1
Week 4
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1
Week 6
|
14 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1
Week 8
|
16 Participants
|
21 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1
Week 12
|
24 Participants
|
24 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1
Week 18
|
29 Participants
|
44 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 26, 30, 36, 44 and 52 (pre-dose)Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.
Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =\<1; or the score on the simplified disease activity index (SDAI) was =\<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2
Week 26
|
38 Participants
|
26 Participants
|
19 Participants
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2
Week 30
|
50 Participants
|
26 Participants
|
27 Participants
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2
Week 36
|
49 Participants
|
21 Participants
|
27 Participants
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2
Week 44
|
56 Participants
|
29 Participants
|
34 Participants
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2
Week 52 (pre-dose)
|
53 Participants
|
28 Participants
|
35 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 52, 56, 66, 76 and 78Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.
Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =\<1; or the score on the simplified disease activity index (SDAI) was =\<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).
Outcome measures
| Measure |
Period 1: PF-06410293
n=259 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=121 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=507 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3
Week 52
|
53 Participants
|
27 Participants
|
34 Participants
|
114 Participants
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3
Week 56
|
63 Participants
|
28 Participants
|
30 Participants
|
121 Participants
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3
Week 66
|
57 Participants
|
31 Participants
|
29 Participants
|
117 Participants
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3
Week 76
|
69 Participants
|
27 Participants
|
36 Participants
|
132 Participants
|
|
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3
Week 78
|
77 Participants
|
34 Participants
|
43 Participants
|
154 Participants
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visitPopulation: The analysis population included all participants who received study drug and provided at least 1 post-dose drug concentration measurement in Period 1.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=299 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Serum Concentration Versus Time Summary: Period 1
Day 1 (Week 0)
|
104.8 ng/mL
Standard Deviation 1125.1
|
187.3 ng/mL
Standard Deviation 1372.7
|
—
|
—
|
|
Serum Concentration Versus Time Summary: Period 1
Day 8 (Week 1)
|
3756 ng/mL
Standard Deviation 1829.8
|
3488 ng/mL
Standard Deviation 1938.2
|
—
|
—
|
|
Serum Concentration Versus Time Summary: Period 1
Day 15 (Week 2)
|
3349 ng/mL
Standard Deviation 1601.0
|
3025 ng/mL
Standard Deviation 1729.7
|
—
|
—
|
|
Serum Concentration Versus Time Summary: Period 1
Day 43 (Week 6)
|
6205 ng/mL
Standard Deviation 3525.6
|
5526 ng/mL
Standard Deviation 3249.2
|
—
|
—
|
|
Serum Concentration Versus Time Summary: Period 1
Day 85 (Week 12)
|
7575 ng/mL
Standard Deviation 4725.1
|
6531 ng/mL
Standard Deviation 4302.5
|
—
|
—
|
|
Serum Concentration Versus Time Summary: Period 1
Day 183 (Week 26)
|
8244 ng/mL
Standard Deviation 5494.6
|
7190 ng/mL
Standard Deviation 5402.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 183, 211, 253 and 365Population: The analysis population included all participants who received study drug and provided at least 1 post-dose drug concentration measurement in Period 2.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=133 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Serum Concentration Versus Time Summary: Period 2
Day 183 (Week 26)
|
8346 ng/mL
Standard Deviation 5463.5
|
7058 ng/mL
Standard Deviation 5174.1
|
7557 ng/mL
Standard Deviation 5492.8
|
—
|
|
Serum Concentration Versus Time Summary: Period 2
Day 211 (Week 30)
|
8314 ng/mL
Standard Deviation 5728.6
|
6831 ng/mL
Standard Deviation 5147.2
|
7626 ng/mL
Standard Deviation 5335.7
|
—
|
|
Serum Concentration Versus Time Summary: Period 2
Day 253 (Week 36)
|
8066 ng/mL
Standard Deviation 5297.3
|
7063 ng/mL
Standard Deviation 5234.2
|
8198 ng/mL
Standard Deviation 5627.9
|
—
|
|
Serum Concentration Versus Time Summary: Period 2
Day 365 (Week 52)
|
7491 ng/mL
Standard Deviation 4946.9
|
6252 ng/mL
Standard Deviation 5054.5
|
8157 ng/mL
Standard Deviation 5648.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 365, 393, 463, 547 and 575Population: The analysis population included all participants who received study drug and provided at least 1 post-dose drug concentration measurement in Period 3.
Outcome measures
| Measure |
Period 1: PF-06410293
n=258 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=120 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=505 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Serum Concentration Versus Time Summary: Period 3
Day 365 (Week 52)
|
7539 ng/mL
Standard Deviation 4933.6
|
6298 ng/mL
Standard Deviation 5063.7
|
8157 ng/mL
Standard Deviation 5648.5
|
7398 ng/mL
Standard Deviation 5184.6
|
|
Serum Concentration Versus Time Summary: Period 3
Day 393 (Week 56)
|
7402 ng/mL
Standard Deviation 5190.6
|
6261 ng/mL
Standard Deviation 4999.6
|
8345 ng/mL
Standard Deviation 5255.0
|
7362 ng/mL
Standard Deviation 5202.5
|
|
Serum Concentration Versus Time Summary: Period 3
Day 463 (Week 66)
|
7364 ng/mL
Standard Deviation 5118.5
|
6482 ng/mL
Standard Deviation 4879.4
|
8118 ng/mL
Standard Deviation 5507.9
|
7340 ng/mL
Standard Deviation 5183.0
|
|
Serum Concentration Versus Time Summary: Period 3
Day 547 (Week 78)
|
6728 ng/mL
Standard Deviation 5003.2
|
6217 ng/mL
Standard Deviation 5118.7
|
7388 ng/mL
Standard Deviation 5380.7
|
6774 ng/mL
Standard Deviation 5134.7
|
|
Serum Concentration Versus Time Summary: Period 3
Day 575 (Follow-up)
|
3355 ng/mL
Standard Deviation 3239.2
|
3069 ng/mL
Standard Deviation 3393.2
|
3802 ng/mL
Standard Deviation 3781.1
|
3397 ng/mL
Standard Deviation 3419.7
|
SECONDARY outcome
Timeframe: Baseline up to Week 26 (pre-dose)Population: The analysis population included all randomized participants who received at least 1 dose of study drug, and had at least 1 ADA measurement in Period 1, analyzed by actual treatment received.
Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer \>=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer \>=0.70.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=298 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1
ADA
|
132 Participants
|
151 Participants
|
—
|
—
|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1
NAb
|
41 Participants
|
42 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26 dosing up to Week 52 (pre-dose)Population: The analysis population included all randomized participants who received at least 1 dose of study treatment in Period 1, and received at least 1 dose of study treatment in Period 2, and had at least 1 ADA measurement in Period 2, analyzed by actual treatment received.
Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer \>=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer \>=0.70.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=133 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2
ADA
|
134 Participants
|
73 Participants
|
61 Participants
|
—
|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2
NAb
|
46 Participants
|
18 Participants
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 dosing up to follow-up visit (Week 92)Population: The analysis population included all participants enrolled and treated in Period 3 who had at least 1 ADA measurement in Period 3.
Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer \>=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer \>=0.70.
Outcome measures
| Measure |
Period 1: PF-06410293
n=258 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=120 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=505 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3
ADA
|
119 Participants
|
65 Participants
|
59 Participants
|
243 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3
NAb
|
54 Participants
|
30 Participants
|
21 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 26 (pre-dose)Population: Safety population (Period 1) was defined as all randomized participants who received at least 1 dose of study treatment, analyzed by actual treatment received.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 1 were events between first dose of study drug in Period 1 and up to Week 26 pre-dose assessments that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=299 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
All-causality TEAE
|
143 Participants
|
143 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
All-causality SAE
|
12 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
Treatment-related TEAE
|
55 Participants
|
69 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
Treatment-related SAE
|
5 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26 dosing up to Week 52 (pre-dose)Population: Safety population (Period 2) was defined as all randomized participants who received at least 1 dose of study treatment in Period 1, and received at least 1 dost of study treatment in Period 2, analyzed by actual treatment received.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 2 were events between first dose of study drug in Period 2 and up to Week 52 pre-dose assessments that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=135 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=133 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
All-causality TEAE
|
123 Participants
|
60 Participants
|
51 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
All-causality SAE
|
4 Participants
|
6 Participants
|
3 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
Treatment-related TEAE
|
32 Participants
|
22 Participants
|
18 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
Treatment-related SAE
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 dosing up to follow-up visit (Week 92)Population: Safety population (Period 3) was defined as all participants enrolled and treated in Period 3.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 3 were events between first dose of study drug in Period 3 and up to Week 92 visit that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.
Outcome measures
| Measure |
Period 1: PF-06410293
n=258 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=120 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=127 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=505 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
All-causality TEAE
|
110 Participants
|
61 Participants
|
47 Participants
|
218 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
All-causality SAE
|
9 Participants
|
9 Participants
|
3 Participants
|
21 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
Treatment-related TEAE
|
27 Participants
|
13 Participants
|
17 Participants
|
57 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
Treatment-related SAE
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 26 (pre-dose)Population: The analysis population included all randomized participants who received at least 1 dose of study treatment and had laboratory test in Period 1, analyzed by actual treatment received.
Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 1 (without regard to baseline abnormality) is presented.
Outcome measures
| Measure |
Period 1: PF-06410293
n=297 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=298 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities: Period 1
|
181 Participants
|
180 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26 dosing up to Week 52 (pre-dose)Population: The analysis population included all randomized participants who received at least 1 dose of study treatment in Period 1, and received at least 1 dost of study treatment in Period 2, and had laboratory test in Period 2, analyzed by actual treatment received.
Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 2 (without regard to baseline abnormality) is presented.
Outcome measures
| Measure |
Period 1: PF-06410293
n=283 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=134 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=133 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities: Period 2
|
171 Participants
|
85 Participants
|
73 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 dosing up to follow-up visit (Week 92)Population: The analysis population included all participants enrolled and treated in Period 3 who had laboratory test in Period 3.
Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 3 (without regard to baseline abnormality) is presented.
Outcome measures
| Measure |
Period 1: PF-06410293
n=256 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=120 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
n=126 Participants
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
n=502 Participants
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities: Period 3
|
176 Participants
|
77 Participants
|
77 Participants
|
330 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 56, 58, 60, 62, 64, 66Population: The analysis population included all participants in the sub-study.
A sub-study was conducted to determine whether participants or their non-healthcare professional caregivers could safely and effectively administer PF-06410293 with the sponsor's prefilled pen (PFP) device.
Outcome measures
| Measure |
Period 1: PF-06410293
n=50 Participants
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: Adalimumab-EU/PF-06410293
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3 Total
This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Delivery Success in Sub-study
Week 56
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved Delivery Success in Sub-study
Week 58
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved Delivery Success in Sub-study
Week 60
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved Delivery Success in Sub-study
Week 62
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved Delivery Success in Sub-study
Week 64
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved Delivery Success in Sub-study
Week 66
|
100.0 percentage of participants
|
—
|
—
|
—
|
Adverse Events
Period 1: PF-06410293
Serious events: 12 serious events
Other events: 21 other events
Deaths: 0 deaths
Period 1: Adalimumab-EU
Serious events: 13 serious events
Other events: 18 other events
Deaths: 1 deaths
Period 2: PF-06410293/PF-06410293
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Period 2: Adalimumab-EU/Adalimumab-EU
Serious events: 6 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 2: Adalimumab-EU/PF-06410293
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Period 3: PF-06410293/PF-06410293/PF-06410293
Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths
Period 3: Adalimumab-EU/Adalimumab-EU/PF-06410293
Serious events: 9 serious events
Other events: 14 other events
Deaths: 1 deaths
Period 3: Adalimumab-EU/PF-06410293/PF-06410293
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: PF-06410293
n=297 participants at risk
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=299 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: PF-06410293/PF-06410293
n=283 participants at risk
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1 and continued to receive PF-06410293 in Period 2. PF-06410293 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 2: Adalimumab-EU/Adalimumab-EU
n=135 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and remained in the adalimumab-EU group in Period 2. Adalimumab-EU 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 2: Adalimumab-EU/PF-06410293
n=133 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3: PF-06410293/PF-06410293/PF-06410293
n=258 participants at risk
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1 and continued to receive PF-06410293 in Period 2 and Period 3. PF-06410293 40 mg was administered every other week by subcutaneous injection in all 3 periods.
|
Period 3: Adalimumab-EU/Adalimumab-EU/PF-06410293
n=120 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, remained in the adalimumab-EU group in Period 2 and received PF-06410293 in Period 3. Study drug 40 mg was administered every other week by subcutaneous injection in all 3 periods.
|
Period 3: Adalimumab-EU/PF-06410293/PF-06410293
n=127 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 from Period 2 and continued on PF-06410293 in Period 3. Study drug 40 mg was administered every other week by subcutaneous injection in all 3 periods.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.39%
1/258 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.74%
1/135 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.67%
2/299 • Number of events 2 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.74%
1/135 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.39%
1/258 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Pyelonephritis acute
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Urosepsis
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Psychiatric disorders
Intentional self-injury
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.67%
2/299 • Number of events 2 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.33%
1/299 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Vascular disorders
Hypertensive crisis
|
0.34%
1/297 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.35%
1/283 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.75%
1/133 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.35%
1/283 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
General disorders
Chest pain
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.35%
1/283 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.74%
1/135 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Ear infection
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.35%
1/283 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.74%
1/135 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.74%
1/135 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.75%
1/133 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.35%
1/283 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.39%
1/258 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 2 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.74%
1/135 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.35%
1/283 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.75%
1/133 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.74%
1/135 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.39%
1/258 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.39%
1/258 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.79%
1/127 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Influenza
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.39%
1/258 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.79%
1/127 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.39%
1/258 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.79%
1/127 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.78%
2/258 • Number of events 2 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.39%
1/258 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.79%
1/127 • Number of events 2 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.79%
1/127 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Vascular disorders
Shock
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/283 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/133 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/258 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.83%
1/120 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
Other adverse events
| Measure |
Period 1: PF-06410293
n=297 participants at risk
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
|
Period 1: Adalimumab-EU
n=299 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
|
Period 2: PF-06410293/PF-06410293
n=283 participants at risk
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1 and continued to receive PF-06410293 in Period 2. PF-06410293 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 2: Adalimumab-EU/Adalimumab-EU
n=135 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and remained in the adalimumab-EU group in Period 2. Adalimumab-EU 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 2: Adalimumab-EU/PF-06410293
n=133 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
|
Period 3: PF-06410293/PF-06410293/PF-06410293
n=258 participants at risk
This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1 and continued to receive PF-06410293 in Period 2 and Period 3. PF-06410293 40 mg was administered every other week by subcutaneous injection in all 3 periods.
|
Period 3: Adalimumab-EU/Adalimumab-EU/PF-06410293
n=120 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, remained in the adalimumab-EU group in Period 2 and received PF-06410293 in Period 3. Study drug 40 mg was administered every other week by subcutaneous injection in all 3 periods.
|
Period 3: Adalimumab-EU/PF-06410293/PF-06410293
n=127 participants at risk
This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 from Period 2 and continued on PF-06410293 in Period 3. Study drug 40 mg was administered every other week by subcutaneous injection in all 3 periods.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.1%
21/297 • Number of events 22 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
6.0%
18/299 • Number of events 18 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
5.3%
15/283 • Number of events 17 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
3.7%
5/135 • Number of events 6 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
4.5%
6/133 • Number of events 6 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.39%
1/258 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/120 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/127 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/297 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/299 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.35%
1/283 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.00%
0/135 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
0.75%
1/133 • Number of events 1 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
5.0%
13/258 • Number of events 16 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
2.5%
3/120 • Number of events 3 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
7.9%
10/127 • Number of events 10 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.7%
5/297 • Number of events 5 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
1.0%
3/299 • Number of events 3 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
1.4%
4/283 • Number of events 4 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
1.5%
2/135 • Number of events 2 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
2.3%
3/133 • Number of events 3 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
4.7%
12/258 • Number of events 14 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
9.2%
11/120 • Number of events 11 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
3.9%
5/127 • Number of events 6 • From the first dose of study drug to Week 92
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event. MedDRAVersion 20.0 was used for Periods 1 and 2; and Version 20.1 was used for Period 3. AEs were analyzed separately for each period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER