Trial Outcomes & Findings for A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive (NCT NCT00264537)
NCT ID: NCT00264537
Last Updated: 2014-09-05
Results Overview
ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
637 participants
Primary outcome timeframe
Week 24
Results posted on
2014-09-05
Participant Flow
A total of 637 participants were enrolled at 90 centers: 25 sites in Asia, 34 sites in Europe/Australia/New Zealand, 10 sites in Latin America and 21 sites in North America.
Participant milestones
| Measure |
Group 1: Placebo + Methotrexate
Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; 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-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 3: Golimumab 50 mg + Methotrexate
Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for 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-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
160
|
159
|
159
|
159
|
|
Overall Study
COMPLETED
|
110
|
101
|
109
|
99
|
|
Overall Study
NOT COMPLETED
|
50
|
58
|
50
|
60
|
Reasons for withdrawal
| Measure |
Group 1: Placebo + Methotrexate
Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; 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-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 3: Golimumab 50 mg + Methotrexate
Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for 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-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
3
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
7
|
6
|
|
Overall Study
Adverse Event
|
21
|
32
|
24
|
34
|
|
Overall Study
Unsatisfactory therapeutic effect
|
5
|
6
|
5
|
7
|
|
Overall Study
Other
|
21
|
11
|
10
|
11
|
|
Overall Study
Not treated
|
0
|
2
|
1
|
0
|
Baseline Characteristics
A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive
Baseline characteristics by cohort
| Measure |
Group 1: Placebo + Methotrexate
n=160 Participants
Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; 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-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 3: Golimumab 50 mg + Methotrexate
n=159 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for 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-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Total
n=637 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 12.91 • n=99 Participants
|
48.2 years
STANDARD_DEVIATION 12.85 • n=107 Participants
|
50.9 years
STANDARD_DEVIATION 11.32 • n=206 Participants
|
50.2 years
STANDARD_DEVIATION 11.87 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 12.28 • n=31 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
125 Participants
n=7 Participants
|
528 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
109 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: All participants randomly assigned to each treatment group. 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 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Outcome measures
| Measure |
Group 1: Placebo + Methotrexate
n=160 Participants
Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; 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-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 3: Golimumab 50 mg + Methotrexate
n=159 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for 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-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Combined Golimumab + Methotrexate
n=318 Participants
Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
|
47 Participants
|
52 Participants
|
64 Participants
|
58 Participants
|
122 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: All participants randomly assigned to each treatment group.
The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.
Outcome measures
| Measure |
Group 1: Placebo + Methotrexate
n=160 Participants
Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; 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-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 3: Golimumab 50 mg + Methotrexate
n=159 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for 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-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Combined Golimumab + Methotrexate
n=318 Participants
Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52
|
1.37 Scores on a scale
Standard Deviation 4.555
|
1.25 Scores on a scale
Standard Deviation 6.155
|
0.74 Scores on a scale
Standard Deviation 5.233
|
0.07 Scores on a scale
Standard Deviation 1.833
|
0.41 Scores on a scale
Standard Deviation 3.929
|
SECONDARY outcome
Timeframe: Week 24Population: All participants randomly assigned to each treatment group. 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 defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 20 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Outcome measures
| Measure |
Group 1: Placebo + Methotrexate
n=160 Participants
Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; 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-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 3: Golimumab 50 mg + Methotrexate
n=159 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for 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-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Combined Golimumab + Methotrexate
n=318 Participants
Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24
|
79 Participants
|
82 Participants
|
98 Participants
|
98 Participants
|
196 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Randomized participants with abnormal baseline CRP. 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 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Outcome measures
| Measure |
Group 1: Placebo + Methotrexate
n=95 Participants
Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; 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-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=90 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 3: Golimumab 50 mg + Methotrexate
n=86 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for 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-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=83 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Combined Golimumab + Methotrexate
n=169 Participants
Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
|
|---|---|---|---|---|---|
|
Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
|
34 Participants
|
26 Participants
|
38 Participants
|
37 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: All participants randomly assigned to each treatment group who had C-reactive protein \> 1.0 mg/dl at baseline.
The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.
Outcome measures
| Measure |
Group 1: Placebo + Methotrexate
n=160 Participants
Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; 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-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 3: Golimumab 50 mg + Methotrexate
n=159 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for 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-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=159 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Combined Golimumab + Methotrexate
n=318 Participants
Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline
|
2.16 Scores on a scale
Standard Deviation 5.642
|
2.19 Scores on a scale
Standard Deviation 7.967
|
1.29 Scores on a scale
Standard Deviation 6.991
|
0.16 Scores on a scale
Standard Deviation 2.195
|
0.74 Scores on a scale
Standard Deviation 5.235
|
Adverse Events
Group A: Golimumab 50 mg SC Injections Only
Serious events: 55 serious events
Other events: 139 other events
Deaths: 0 deaths
Group B: Golimumab 100 mg SC Injections Only
Serious events: 94 serious events
Other events: 215 other events
Deaths: 0 deaths
Group C: Golimumab 50 and 100 mg SC Injections
Serious events: 55 serious events
Other events: 174 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Golimumab 50 mg SC Injections Only
n=172 participants at risk
Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study. Participants were included from Group 1 and Group 3, who received only Golimumab 50 mg SC Injections.
|
Group B: Golimumab 100 mg SC Injections Only
n=243 participants at risk
Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2 and Group 4, who received only Golimumab 100 mg SC Injections.
|
Group C: Golimumab 50 and 100 mg SC Injections
n=201 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. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2, Group 3 and Group 4, who received Golimumab 50 mg and 100 mg SC Injections.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Angina Unstable
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Myocardial Infarction
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.2%
2/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Endocrine disorders
Addison's Disease
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Eye disorders
Cataract
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Eye disorders
Retinal Artery Embolism
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
1.2%
2/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer Haemorrhage
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Haematochezia
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
General disorders
Chest Pain
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
General disorders
Pyrexia
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
General disorders
Sudden Death
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.2%
3/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Hepatobiliary disorders
Cholestasis of Pregnancy
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Hepatobiliary disorders
Hepatitis Toxic
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.00%
2/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Appendicitis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.00%
2/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Bone Tuberculosis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Breast Abscess
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Bronchitis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Bursitis Infective
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Cellulitis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Chronic Tonsillitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Cystitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Empyema
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Encephalitis Viral
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Enteritis Infectious
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
H1n1 Influenza
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.5%
3/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Intervertebral Discitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Necrotising Fasciitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Orchitis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Peritoneal Tuberculosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Peritonitis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Pneumocystis JiroveCI Pneumonia
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Pneumonia
|
2.9%
5/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.6%
4/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
2.5%
5/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Pneumonia Legionella
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.6%
4/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.00%
2/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Sepsis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.2%
3/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Septic Shock
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Tuberculosis Gastrointestinal
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Tuberculous Pleurisy
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Urinary Tract Infection
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.00%
2/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Vulval Abscess
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Open Fracture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Synovial Rupture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Investigations
General Physical Condition Abnormal
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Investigations
Weight Increased
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.2%
2/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's Contracture
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.00%
2/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.00%
2/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
2.5%
6/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Vertebral Foraminal Stenosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma Benign
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital Warts
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.00%
2/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's Disease
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.2%
3/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in Situ
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's Disease
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma in Situ
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
1.2%
2/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Adenoma
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.00%
2/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Cerebral Infarction
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Hypoglycaemic Coma
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Migraine
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Multiple Sclerosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
1.6%
4/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Psychiatric disorders
Bipolar Disorder
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Psychiatric disorders
Bipolar I Disorder
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Psychiatric disorders
Completed Suicide
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Psychiatric disorders
Delusional Disorder, Unspecified Type
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Psychiatric disorders
Depression
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Psychiatric disorders
Mania
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Renal and urinary disorders
Bladder Prolapse
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Renal and urinary disorders
Urethral Disorder
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Reproductive system and breast disorders
Breast Calcifications
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Reproductive system and breast disorders
Breast Inflammation
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Reproductive system and breast disorders
Fibrocystic Breast Disease
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Reproductive system and breast disorders
Uterine Cervical Squamous Metaplasia
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis Fibrosing
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic Cyst
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Rheumatoid Lung
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Cutaneous Lupus Erythematosus
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Generalised Erythema
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Pustular Psoriasis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Arterial Stenosis
|
0.58%
1/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Haematoma
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Hypertension
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Hypotension
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.41%
1/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Varicose Ulceration
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Venous Thrombosis
|
0.00%
0/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.00%
0/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.50%
1/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
Other adverse events
| Measure |
Group A: Golimumab 50 mg SC Injections Only
n=172 participants at risk
Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study. Participants were included from Group 1 and Group 3, who received only Golimumab 50 mg SC Injections.
|
Group B: Golimumab 100 mg SC Injections Only
n=243 participants at risk
Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2 and Group 4, who received only Golimumab 100 mg SC Injections.
|
Group C: Golimumab 50 and 100 mg SC Injections
n=201 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. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2, Group 3 and Group 4, who received Golimumab 50 mg and 100 mg SC Injections.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
5/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
3.7%
9/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
5.5%
11/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.8%
10/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
4.5%
11/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
3.5%
7/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.7%
8/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.2%
20/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.5%
17/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
15/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.0%
17/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.5%
17/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
18/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.0%
17/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
10.4%
21/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Gastritis
|
4.1%
7/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
6.6%
16/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
5.0%
10/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Nausea
|
12.8%
22/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
22.6%
55/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
21.9%
44/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
8/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.0%
17/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
9.0%
18/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
General disorders
Fatigue
|
4.1%
7/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.6%
21/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
5.0%
10/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
General disorders
Injection Site Erythema
|
5.8%
10/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
11.5%
28/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
6.0%
12/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
General disorders
Pyrexia
|
2.3%
4/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
5.3%
13/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.0%
14/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Bronchitis
|
15.1%
26/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
16.5%
40/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
16.9%
34/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Gastroenteritis
|
5.2%
9/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
4.5%
11/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
6.5%
13/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Influenza
|
7.0%
12/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.0%
17/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.0%
16/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Nasopharyngitis
|
11.6%
20/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
12.8%
31/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
16.4%
33/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Oral Herpes
|
4.1%
7/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
0.82%
2/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
6.0%
12/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Pharyngitis
|
9.3%
16/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
11.1%
27/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
10.0%
20/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Respiratory Tract Infection
|
5.2%
9/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
4.5%
11/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
2.5%
5/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Sinusitis
|
15.1%
26/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.8%
19/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
11.9%
24/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
26.2%
45/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
25.5%
62/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
35.8%
72/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Infections and infestations
Urinary Tract Infection
|
8.7%
15/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
11.5%
28/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.0%
16/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Investigations
Alanine Aminotransferase Increased
|
18.0%
31/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
14.8%
36/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
15.9%
32/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.2%
21/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.6%
21/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
11.9%
24/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
8/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.6%
21/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.5%
17/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.9%
17/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
9.5%
23/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
10.9%
22/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
1.7%
3/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.8%
19/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
5.5%
11/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Dizziness
|
3.5%
6/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
6.2%
15/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
4.0%
8/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Headache
|
8.1%
14/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
13.6%
33/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.0%
16/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Nervous system disorders
Paraesthesia
|
2.3%
4/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
2.9%
7/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
5.5%
11/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Psychiatric disorders
Depression
|
9.3%
16/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
4.1%
10/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
10.4%
21/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Psychiatric disorders
Insomnia
|
2.3%
4/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.0%
17/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
4.5%
9/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.0%
19/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
15.2%
37/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
14.4%
29/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.1%
7/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
4.9%
12/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
8.0%
16/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.5%
6/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
4.9%
12/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.0%
14/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
9/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.4%
18/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
7.5%
15/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
|
Vascular disorders
Hypertension
|
11.0%
19/172 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
10.3%
25/243 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
11.4%
23/201 • Adverse event data were collected for 5 years
3 of 637 randomized participants did not receive treatment \& additional 18 participants did not receive any treatment with golimumab during the study. Thus only 616 participants are included in 5-year safety data. AEs were planned to be reported in relation to the doses of golimumab received throughout the study, rather than the treatment regimen.
|
Additional Information
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