Trial Outcomes & Findings for A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s) (NCT NCT00299546)
NCT ID: NCT00299546
Last Updated: 2014-02-27
Results Overview
ACR 20 response is an improvement of \>= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
461 participants
Primary outcome timeframe
Week 14
Results posted on
2014-02-27
Participant Flow
A total of 461 participants were enrolled at 86 sites in North America, Europe, Australia and New Zealand.
Participant milestones
| Measure |
Group 1: Placebo
Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
|
Group 2: Golimumab 50 mg
Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
|
Group 3: Golimumab 100 mg
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
|
|---|---|---|---|
|
Overall Study
STARTED
|
155
|
153
|
153
|
|
Overall Study
COMPLETED
|
55
|
61
|
67
|
|
Overall Study
NOT COMPLETED
|
100
|
92
|
86
|
Reasons for withdrawal
| Measure |
Group 1: Placebo
Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
|
Group 2: Golimumab 50 mg
Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
|
Group 3: Golimumab 100 mg
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
5
|
|
Overall Study
Adverse Event
|
37
|
22
|
27
|
|
Overall Study
Unsatisfactory therapeutic effect
|
34
|
39
|
34
|
|
Overall Study
Other
|
24
|
26
|
19
|
|
Overall Study
Not treated
|
0
|
1
|
1
|
Baseline Characteristics
A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)
Baseline characteristics by cohort
| Measure |
Group 1: Placebo
n=155 Participants
Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
|
Group 2: Golimumab 50 mg
n=153 Participants
Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
|
Group 3: Golimumab 100 mg
n=153 Participants
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
|
Total
n=461 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 13.07 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 11.47 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 12.27 • n=4 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
367 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.
ACR 20 response is an improvement of \>= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)
Outcome measures
| Measure |
Group 1: Placebo
n=150 Participants
Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 2: Golimumab 50 mg
n=147 Participants
Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 3: Golimumab 100 mg
n=148 Participants
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
|
Combined Golimumab
n=295 Participants
Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) 20 Response at Week 14.
|
27 participants
|
51 participants
|
54 participants
|
105 participants
|
SECONDARY outcome
Timeframe: Week 14Population: Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.
Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of \>= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).
Outcome measures
| Measure |
Group 1: Placebo
n=150 Participants
Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 2: Golimumab 50 mg
n=147 Participants
Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 3: Golimumab 100 mg
n=148 Participants
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
|
Combined Golimumab
n=295 Participants
Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) 50 Response at Week 14
|
10 participants
|
22 participants
|
27 participants
|
49 participants
|
SECONDARY outcome
Timeframe: Week 14Population: Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing DAS 28 components imputed by Last Observation Carried Forward unless all components were missing; in which case considered non-responders.
DAS 28 using C-reactive protein (CRP) is an index to measure disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst).
Outcome measures
| Measure |
Group 1: Placebo
n=150 Participants
Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 2: Golimumab 50 mg
n=147 Participants
Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 3: Golimumab 100 mg
n=148 Participants
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
|
Combined Golimumab
n=295 Participants
Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
|
|---|---|---|---|---|
|
Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14
|
44 participants
|
82 participants
|
87 participants
|
169 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components imputed by LOCF unless all components were missing; in which case considered non-responders. Wk 16 ACR response used for change in study tx.
Number of patients who achieved ACR 20 response at Week (Wk) 24. ACR 20 response is an improvement of \>= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)
Outcome measures
| Measure |
Group 1: Placebo
n=150 Participants
Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 2: Golimumab 50 mg
n=147 Participants
Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 3: Golimumab 100 mg
n=148 Participants
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
|
Combined Golimumab
n=295 Participants
Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) 20 at Week 24
|
24 participants
|
46 participants
|
63 participants
|
109 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Randomized participants (excluding 1 site). Missing scores imputed by Last Observation Carried Forward. Week 16 scores were used for participants with change in study treatment.
Improvement from baseline in HAQ score at Week 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3.
Outcome measures
| Measure |
Group 1: Placebo
n=150 Participants
Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 2: Golimumab 50 mg
n=147 Participants
Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
|
Group 3: Golimumab 100 mg
n=148 Participants
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
|
Combined Golimumab
n=295 Participants
Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
|
|---|---|---|---|---|
|
Health Assessment Questionnaire (HAQ) Score at Week 24
|
0.0000 scores on a scale
Interval -0.25 to 0.25
|
0.1250 scores on a scale
Interval 0.0 to 0.5
|
0.2500 scores on a scale
Interval 0.0 to 0.5
|
0.2500 scores on a scale
Interval 0.0 to 0.5
|
Adverse Events
Group 1: Golimumab 50 mg SC Injections Only
Serious events: 34 serious events
Other events: 76 other events
Deaths: 0 deaths
Group 2: Golimumab 100 mg SC Injections Only
Serious events: 46 serious events
Other events: 117 other events
Deaths: 0 deaths
Group 3: Golimumab 50 and 100 mg SC Injections
Serious events: 71 serious events
Other events: 172 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Golimumab 50 mg SC Injections Only
n=98 participants at risk
Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.
|
Group 2: Golimumab 100 mg SC Injections Only
n=138 participants at risk
Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.
|
Group 3: Golimumab 50 and 100 mg SC Injections
n=195 participants at risk
Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Atrial Flutter
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.4%
2/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Cardiovascular Disorder
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.4%
2/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Cardiac disorders
Torsade De Pointes
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Congenital, familial and genetic disorders
Branchial Cleft Cyst
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.4%
2/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Splenic Artery Aneurysm
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Chest Pain
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Device Breakage
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Device Dislocation
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Device Failure
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Generalised Oedema
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Hernia
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Pain
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Pyrexia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Hepatobiliary disorders
Biliary Cirrhosis Primary
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Appendicitis
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Bronchitis
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Cellulitis
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Cellulitis Streptococcal
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.4%
2/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Extradural Abscess
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Histoplasmosis Disseminated
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Infected Skin Ulcer
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Infection
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Intervertebral Discitis
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Lung Infection Pseudomonal
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Pelvic Abscess
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Periorbital Cellulitis
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Pneumonia
|
3.1%
3/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
3.6%
5/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
10/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.6%
5/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Staphylococcal Abscess
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.4%
2/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.6%
5/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Urosepsis
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Fractured Sacrum
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Open Fracture
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Stress Fracture
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.4%
2/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Bone Disorder
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
4.1%
8/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.4%
2/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
4.1%
8/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Nodule
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.2%
3/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma Cell Type Unspecified Stage Iv
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary Tract Neoplasm
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.2%
3/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Migraine
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Sciatica
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Viith Nerve Paralysis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Renal and urinary disorders
Calculus Urinary
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Renal and urinary disorders
Renal Disorder
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Renal and urinary disorders
Vesical Fistula
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.4%
2/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Mass
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Fibrosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.4%
2/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Surgical and medical procedures
Drug Detoxification
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Aortic Thrombosis
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.2%
3/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Haemorrhage
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.72%
1/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Labile Blood Pressure
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.51%
1/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
Other adverse events
| Measure |
Group 1: Golimumab 50 mg SC Injections Only
n=98 participants at risk
Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.
|
Group 2: Golimumab 100 mg SC Injections Only
n=138 participants at risk
Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.
|
Group 3: Golimumab 50 and 100 mg SC Injections
n=195 participants at risk
Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
5.1%
5/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.9%
4/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.1%
4/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Eye disorders
Dry Eye
|
5.1%
5/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.9%
4/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.6%
5/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
15.9%
22/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
14.4%
28/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
4.3%
6/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
10/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Nausea
|
9.2%
9/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
13.0%
18/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
10.8%
21/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
3/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
8.7%
12/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
3.6%
7/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Fatigue
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
11.6%
16/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
8.2%
16/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Injection Site Erythema
|
6.1%
6/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
9.4%
13/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
9.2%
18/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Oedema Peripheral
|
3.1%
3/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
7.2%
10/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.6%
11/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
General disorders
Pyrexia
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.9%
4/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
10/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Immune system disorders
Seasonal Allergy
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
6.5%
9/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Bronchitis
|
11.2%
11/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
15.9%
22/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
12.3%
24/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Ear Infection
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
7/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
4.1%
8/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Influenza
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
7/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
7.7%
15/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
10/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
18.8%
26/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
19.0%
37/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Oral Herpes
|
6.1%
6/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
6.5%
9/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
3.6%
7/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Pneumonia
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
7/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
3.1%
6/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Rhinitis
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
6.5%
9/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.0%
2/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Sinusitis
|
19.4%
19/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
16.7%
23/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
17.9%
35/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
25.5%
25/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
31.2%
43/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
25.1%
49/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Urinary Tract Infection
|
13.3%
13/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
8.7%
12/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
11.3%
22/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Infections and infestations
Viral Infection
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
7/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.1%
4/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.8%
8/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
6.2%
12/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.1%
3/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
4.3%
6/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
10/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
7/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
7.2%
14/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Investigations
Alanine Aminotransferase Increased
|
6.1%
6/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
0.00%
0/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.6%
5/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
12/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
14.5%
20/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
12.8%
25/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.2%
8/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
12.3%
17/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
18.5%
36/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
4.3%
6/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
10/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.8%
8/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
1.5%
3/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
8.7%
12/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
3.1%
6/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
6.5%
9/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
7.7%
15/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.1%
3/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
3.6%
5/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
6.7%
13/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
6.5%
9/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
8.2%
16/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
14.3%
14/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
16.7%
23/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
27.2%
53/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
8.7%
12/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
8.2%
16/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Dizziness
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.8%
8/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.1%
10/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Headache
|
14.3%
14/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
10.1%
14/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
9.7%
19/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
2/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.8%
8/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
2.6%
5/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Nervous system disorders
Paraesthesia
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.8%
8/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.6%
11/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
8.7%
12/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.6%
11/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Psychiatric disorders
Depression
|
3.1%
3/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.8%
8/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
9.2%
18/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
8.0%
11/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.6%
11/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
10/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
9.4%
13/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
12.3%
24/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.8%
8/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
7.7%
15/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
4/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
5.8%
8/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
9.7%
19/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
|
Vascular disorders
Hypertension
|
10.2%
10/98 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
12.3%
17/138 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
17.4%
34/195 • Adverse event data were collected for 5 years
Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.
|
Additional Information
Associate Director Clinical Research
Centocor Research & Development, Inc.
Phone: 1-800-457-6399
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER