Trial Outcomes & Findings for An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate (NCT NCT01764997)
NCT ID: NCT01764997
Last Updated: 2017-07-27
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
776 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2017-07-27
Participant Flow
The study was conducted at 228 sites in 31 countries. A total of 1949 participants were screened between 09 May 2013 and 07 Aug 2014 of which 1173 participants were screen failures and a total of 776 participants entered in the adalimumab run-in phase of the study.
Of 776 participants, 365 completed adalimumab run-in phase, of whom 43 non-responders randomized (1:1:1) in double-blind fashion to receive sarilumab 150 mg, sarilumab 200 mg or etanercept 50 mg; 322 responders entered in open label sub-study. 373 participants did not proceed into randomized phase or sub-study and 38 discontinued from run-in phase.
Participant milestones
| Measure |
Adalimumab Open Label run-in
Adalimumab 40 mg subcutaneous (SC) injection every 2 weeks (Q2W) for 16 weeks added to stable dose of methotrexate (MTX).
|
Etanercept + MTX (Randomized)
Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
|
Sarilumab 150 mg + MTX (Randomized)
Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
|
Sarilumab 200 mg + MTX (Randomized)
Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
|
Sarilumab 150 mg + MTX Open Label Sub-study
Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
|
|---|---|---|---|---|---|
|
Run-in Period
STARTED
|
776
|
0
|
0
|
0
|
0
|
|
Run-in Period
COMPLETED
|
738
|
0
|
0
|
0
|
0
|
|
Run-in Period
NOT COMPLETED
|
38
|
0
|
0
|
0
|
0
|
|
Study Drug Treatment Period
STARTED
|
0
|
17
|
13
|
13
|
322
|
|
Study Drug Treatment Period
COMPLETED
|
0
|
16
|
13
|
13
|
286
|
|
Study Drug Treatment Period
NOT COMPLETED
|
0
|
1
|
0
|
0
|
36
|
Reasons for withdrawal
| Measure |
Adalimumab Open Label run-in
Adalimumab 40 mg subcutaneous (SC) injection every 2 weeks (Q2W) for 16 weeks added to stable dose of methotrexate (MTX).
|
Etanercept + MTX (Randomized)
Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
|
Sarilumab 150 mg + MTX (Randomized)
Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
|
Sarilumab 200 mg + MTX (Randomized)
Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
|
Sarilumab 150 mg + MTX Open Label Sub-study
Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
|
|---|---|---|---|---|---|
|
Run-in Period
Adverse Event
|
15
|
0
|
0
|
0
|
0
|
|
Run-in Period
Lack of Efficacy
|
5
|
0
|
0
|
0
|
0
|
|
Run-in Period
Poor compliance to protocol
|
1
|
0
|
0
|
0
|
0
|
|
Run-in Period
Other than specified above
|
17
|
0
|
0
|
0
|
0
|
|
Study Drug Treatment Period
Adverse Event
|
0
|
1
|
0
|
0
|
24
|
|
Study Drug Treatment Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
2
|
|
Study Drug Treatment Period
Other than specified above
|
0
|
0
|
0
|
0
|
10
|
Baseline Characteristics
An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
Baseline characteristics by cohort
| Measure |
Adalimumab Open Label run-in Treatment Only
n=411 Participants
Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX during run-in period. Participants who were not randomized in the main study or did not enter the sub-study were included in this arm for safety assessment.
|
Etanercept + MTX (Randomized)
n=17 Participants
Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
|
Sarilumab 150 mg + MTX (Randomized)
n=13 Participants
Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
|
Sarilumab 200 mg + MTX (Randomized)
n=13 Participants
Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
|
Sarilumab 150 mg + MTX Open Label Sub-study
n=322 Participants
Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
|
Total
n=776 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
360 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
274 Participants
n=31 Participants
|
668 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
108 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
342 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
261 Participants
n=31 Participants
|
637 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
139 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
Adverse Events
Adalimumab Open Label run-in
Serious events: 25 serious events
Other events: 132 other events
Deaths: 0 deaths
Etanercept + MTX (Randomized)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Sarilumab 150 mg + MTX (Randomized)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Sarilumab 200 mg + MTX (Randomized)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sarilumab 150 mg + MTX Open Label Sub-study
Serious events: 11 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab Open Label run-in
n=776 participants at risk
Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX. AEs in this group were those collected from signature of the informed consent form up to the end of Adalimumab treatment (Week 16).
|
Etanercept + MTX (Randomized)
n=17 participants at risk
Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
|
Sarilumab 150 mg + MTX (Randomized)
n=13 participants at risk
Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
|
Sarilumab 200 mg + MTX (Randomized)
n=13 participants at risk
Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
|
Sarilumab 150 mg + MTX Open Label Sub-study
n=322 participants at risk
Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX. AEs in this group were those collected from enrollment in the sub-study up to the final visit (Week 58).
|
|---|---|---|---|---|---|
|
Infections and infestations
Arthritis bacterial
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Cellulitis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Cholecystitis infective
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Histoplasmosis disseminated
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Oral herpes
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Pneumonia
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Pyelonephritis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Viral parotitis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Psychiatric disorders
Suicide attempt
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Nervous system disorders
Syncope
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Eye disorders
Blindness
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Vascular disorders
Haematoma
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Vascular disorders
Hypertensive crisis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Vascular disorders
Ischaemia
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Investigations
Influenza B virus test positive
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Investigations
Liver function test abnormal
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
Other adverse events
| Measure |
Adalimumab Open Label run-in
n=776 participants at risk
Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX. AEs in this group were those collected from signature of the informed consent form up to the end of Adalimumab treatment (Week 16).
|
Etanercept + MTX (Randomized)
n=17 participants at risk
Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
|
Sarilumab 150 mg + MTX (Randomized)
n=13 participants at risk
Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
|
Sarilumab 200 mg + MTX (Randomized)
n=13 participants at risk
Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
|
Sarilumab 150 mg + MTX Open Label Sub-study
n=322 participants at risk
Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX. AEs in this group were those collected from enrollment in the sub-study up to the final visit (Week 58).
|
|---|---|---|---|---|---|
|
Infections and infestations
Body tinea
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Hordeolum
|
0.26%
2/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Pharyngitis
|
0.90%
7/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.93%
3/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Rash pustular
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Sinusitis
|
0.90%
7/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
1.6%
5/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Tinea versicolour
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
27/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.0%
16/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
16/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
1.2%
4/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.26%
2/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
15.4%
2/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
10.2%
33/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
10/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
1.6%
5/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
8/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.93%
3/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.52%
4/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.62%
2/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.64%
5/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
1.2%
4/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.62%
2/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.26%
2/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.62%
2/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
General disorders
Fatigue
|
0.39%
3/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.62%
2/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
General disorders
Injection site erythema
|
1.2%
9/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
4.7%
15/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
General disorders
Injection site pain
|
1.2%
9/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.93%
3/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
General disorders
Injection site pruritus
|
0.64%
5/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
2.8%
9/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
General disorders
Injection site rash
|
0.77%
6/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
2.2%
7/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
General disorders
Injection site swelling
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.62%
2/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
General disorders
Peripheral swelling
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
General disorders
Pyrexia
|
0.90%
7/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.31%
1/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
0.64%
5/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
15.4%
2/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
3.4%
11/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.13%
1/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.93%
3/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
7.7%
1/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
1.2%
4/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
3.1%
24/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
23.1%
3/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
4.3%
14/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/776 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
5.9%
1/17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
0.00%
0/322 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER