Trial Outcomes & Findings for An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy (NCT NCT00264550)
NCT ID: NCT00264550
Last Updated: 2014-04-29
Results Overview
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 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain 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
444 participants
Primary outcome timeframe
Week 14
Results posted on
2014-04-29
Participant Flow
A total of 444 participants were enrolled at 60 sites in 12 countries.
Participant milestones
| Measure |
Group 1: Placebo + Methotrexate
Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg 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 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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
|
133
|
133
|
89
|
89
|
|
Overall Study
COMPLETED
|
90
|
92
|
72
|
59
|
|
Overall Study
NOT COMPLETED
|
43
|
41
|
17
|
30
|
Reasons for withdrawal
| Measure |
Group 1: Placebo + Methotrexate
Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg 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 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
23
|
18
|
9
|
14
|
|
Overall Study
Unsatisfactory therapeutic effect
|
4
|
11
|
4
|
6
|
|
Overall Study
Discontinued oral study agent
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
13
|
7
|
3
|
9
|
Baseline Characteristics
An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
Group 1: Placebo + Methotrexate
n=133 Participants
Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=133 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=89 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=89 Participants
Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=444 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
50 years
STANDARD_DEVIATION 11.47 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
50 years
STANDARD_DEVIATION 10.78 • n=4 Participants
|
50.4 years
STANDARD_DEVIATION 11.36 • n=21 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
358 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: All participants randomly assigned to each treatment group
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 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain 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=133 Participants
Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=133 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=89 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=89 Participants
Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=178 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 14
|
44 Participants
|
59 Participants
|
49 Participants
|
50 Participants
|
99 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 24Population: All participants randomly assigned to each treatment group
HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).
Outcome measures
| Measure |
Group 1: Placebo + Methotrexate
n=133 Participants
Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=133 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=89 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=89 Participants
Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=178 Participants
Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
|
|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24
|
0.1250 Units on a scale
Interval -0.125 to 0.375
|
0.1250 Units on a scale
Interval -0.25 to 0.625
|
0.3750 Units on a scale
Interval 0.125 to 0.75
|
0.5000 Units on a scale
Interval 0.125 to 0.75
|
0.4375 Units on a scale
Interval 0.125 to 0.75
|
SECONDARY outcome
Timeframe: Week 14Population: All participants randomly assigned to each treatment group
DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of \<= 3.2 (good response) or \> 3.2 to 5.1 (moderate response).
Outcome measures
| Measure |
Group 1: Placebo + Methotrexate
n=133 Participants
Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=133 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=89 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=89 Participants
Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=178 Participants
Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
|
|---|---|---|---|---|---|
|
Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14
|
67 Participants
|
84 Participants
|
64 Participants
|
67 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: All participants randomly assigned to each treatment group
An 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 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (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 (CRP).
Outcome measures
| Measure |
Group 1: Placebo + Methotrexate
n=133 Participants
Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=133 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=89 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=89 Participants
Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=178 Participants
Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24
|
37 Participants
|
47 Participants
|
53 Participants
|
53 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 14Population: All participants randomly assigned to each treatment group
The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).
Outcome measures
| Measure |
Group 1: Placebo + Methotrexate
n=133 Participants
Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=133 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=89 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=89 Participants
Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=178 Participants
Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
|
|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14
|
0.1250 Units on a scale
Interval -0.125 to 0.375
|
0.2500 Units on a scale
Interval -0.125 to 0.625
|
0.3750 Units on a scale
Interval 0.125 to 0.75
|
0.3750 Units on a scale
Interval 0.125 to 0.625
|
0.3750 Units on a scale
Interval 0.125 to 0.75
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 24Population: All participants randomly assigned to each treatment group
The vdH-S score is the sum of joint erosion score and 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=133 Participants
Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 2: Golimumab 100 mg + Placebo
n=133 Participants
Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=89 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
|
Group 4: Golimumab 100 mg + Methotrexate
n=89 Participants
Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; 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=178 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 24
|
0.00 Units on a scale
Inter-Quartile Range 2.354 • Interval 0.0 to 0.5
|
0.00 Units on a scale
Inter-Quartile Range 1.598 • Interval 0.0 to 0.5
|
0.00 Units on a scale
Inter-Quartile Range 2.740 • Interval 0.0 to 0.5
|
0.00 Units on a scale
Inter-Quartile Range 1.342 • Interval 0.0 to 0.5
|
0.00 Units on a scale
Inter-Quartile Range 2.159 • Interval 0.0 to 0.5
|
Adverse Events
Group 1: Golimumab 50 mg SC Injections Only
Serious events: 33 serious events
Other events: 96 other events
Deaths: 0 deaths
Group 2: Golimumab 100 mg SC Injections Only
Serious events: 84 serious events
Other events: 160 other events
Deaths: 0 deaths
Group 3: Golimumab 50 and 100 mg SC Injections
Serious events: 55 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Golimumab 50 mg SC Injections Only
n=105 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.
|
Group 2: Golimumab 100 mg SC Injections Only
n=184 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.
|
Group 3: Golimumab 50 and 100 mg SC Injections
n=145 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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Cyanosis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Dressler's Syndrome
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Endocrine disorders
Goitre
|
1.9%
2/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Eye disorders
Scleritis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Eye disorders
Scotoma
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Oesophagitis Ulcerative
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Parotid Gland Enlargement
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
General disorders
Chest Pain
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
General disorders
Necrosis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
General disorders
Pain
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
General disorders
Pyrexia
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Hepatobiliary disorders
Acute Hepatic Failure
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.7%
5/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.1%
3/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Immune system disorders
Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Arthritis Bacterial
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Arthritis Infective
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Cellulitis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.2%
4/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Chronic Tonsillitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Disseminated Tuberculosis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Empyema
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Herpes Zoster
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Incision Site Cellulitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Peritoneal Tuberculosis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.6%
3/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Sepsis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.7%
5/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Septic Arthritis Staphylococcal
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Tuberculous Pleurisy
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Vulval Cellulitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Abdominal Injury
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Brain Contusion
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Limb Crushing Injury
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Postpericardiotomy Syndrome
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Spinal Column Injury
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Investigations
Weight Decreased
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.6%
3/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Joint Destruction
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.6%
3/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.1%
3/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
1.9%
2/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
3.3%
6/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
3.4%
5/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Nodule
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.9%
2/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.2%
4/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's Disease
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in Situ
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma Metastatic
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative Disorder
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
1.9%
2/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.1%
3/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Axonal Neuropathy
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Convulsion
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Hypoaesthesia
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Migraine
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Paresis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Syncope
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Renal and urinary disorders
Incontinence
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Reproductive system and breast disorders
Breast Calcifications
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Reproductive system and breast disorders
Breast Enlargement
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Reproductive system and breast disorders
Dysfunctional Uterine Bleeding
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Reproductive system and breast disorders
Menopausal Symptoms
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Reproductive system and breast disorders
Pelvic Adhesions
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Disorder
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Disorder
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Polyp
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Vascular disorders
Hypertensive Emergency
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.54%
1/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Vascular disorders
Venous Thrombosis
|
0.00%
0/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.00%
0/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
Other adverse events
| Measure |
Group 1: Golimumab 50 mg SC Injections Only
n=105 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.
|
Group 2: Golimumab 100 mg SC Injections Only
n=184 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.
|
Group 3: Golimumab 50 and 100 mg SC Injections
n=145 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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
5/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.0%
11/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.8%
7/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
3/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.0%
11/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.8%
7/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
8.6%
9/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
7.1%
13/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.3%
15/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.2%
16/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
13.0%
24/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
7.6%
11/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
7/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.0%
11/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.8%
4/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
7/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.9%
9/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
3.4%
5/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
4.8%
5/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
3.3%
6/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
5.5%
8/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
9/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
12.5%
23/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
7.6%
11/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
General disorders
Fatigue
|
10.5%
11/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.9%
9/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.1%
3/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
General disorders
Injection Site Erythema
|
3.8%
4/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.9%
20/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.1%
3/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
General disorders
Oedema Peripheral
|
1.9%
2/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
5.4%
10/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.2%
9/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Bronchitis
|
17.1%
18/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
14.7%
27/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
19.3%
28/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Fungal Skin Infection
|
5.7%
6/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.1%
2/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Gastroenteritis
|
3.8%
4/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.0%
11/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.8%
7/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Herpes Zoster
|
8.6%
9/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.0%
11/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.9%
10/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Influenza
|
3.8%
4/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.0%
11/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.2%
9/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
15/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
19.0%
35/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
16.6%
24/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Oral Herpes
|
3.8%
4/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.9%
9/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
7.6%
11/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Pharyngitis
|
12.4%
13/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.9%
20/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
17.2%
25/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Rhinitis
|
6.7%
7/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.7%
5/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.1%
3/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Sinusitis
|
5.7%
6/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.9%
20/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
11.0%
16/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
37.1%
39/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
34.8%
64/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
26.9%
39/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Infections and infestations
Urinary Tract Infection
|
8.6%
9/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.9%
20/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
13.8%
20/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.8%
5/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
7.1%
13/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
5.5%
8/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Investigations
Alanine Aminotransferase Increased
|
7.6%
8/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.3%
19/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
7.6%
11/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Investigations
Aspartate Aminotransferase Increased
|
4.8%
5/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
9.2%
17/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.8%
7/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.7%
7/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
7.6%
14/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.9%
10/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
16/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
9.8%
18/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.3%
15/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.5%
10/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
12.0%
22/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
13.8%
20/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.8%
4/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
5.4%
10/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.8%
7/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.8%
4/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
5.4%
10/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.8%
4/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.8%
4/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
5.4%
10/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.1%
6/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
12.4%
13/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
12.0%
22/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.3%
15/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Nervous system disorders
Headache
|
12.4%
13/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
12.0%
22/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
13.8%
20/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Psychiatric disorders
Depression
|
0.95%
1/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
5.4%
10/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.9%
10/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Psychiatric disorders
Insomnia
|
2.9%
3/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.0%
11/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
6.2%
9/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.9%
24/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
19.0%
35/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
9.7%
14/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
9.5%
10/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
5.4%
10/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.8%
7/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
7.6%
8/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.3%
8/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
0.69%
1/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
7/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
3.3%
6/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
4.1%
6/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
6.7%
7/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.6%
3/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.1%
3/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
6/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
3.3%
6/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
2.8%
4/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
3/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.3%
19/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
10.3%
15/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
7.6%
8/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
3.3%
6/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
1.4%
2/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
|
Vascular disorders
Hypertension
|
7.6%
8/105 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
13.6%
25/184 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
14.5%
21/145 • Adverse event data were collected for 5 years
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
|
Additional Information
Director Clinical Research
Centocor Research & Development, Inc.
Phone: 1-800-457-6399
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60