Trial Outcomes & Findings for Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice (NCT NCT01077258)
NCT ID: NCT01077258
Last Updated: 2014-04-25
Results Overview
The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Recruitment status
COMPLETED
Target enrollment
4208 participants
Primary outcome timeframe
Baseline and Months 3, 6, 9, 12, 18, and 24
Results posted on
2014-04-25
Participant Flow
Participant milestones
| Measure |
Rheumatoid Arthritis
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
|---|---|
|
Overall Study
STARTED
|
4208
|
|
Overall Study
COMPLETED
|
1640
|
|
Overall Study
NOT COMPLETED
|
2568
|
Reasons for withdrawal
| Measure |
Rheumatoid Arthritis
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1390
|
|
Overall Study
Adverse drug reaction
|
218
|
|
Overall Study
Lack of Efficacy
|
663
|
|
Overall Study
Clinical remission
|
37
|
|
Overall Study
Other reasons
|
260
|
Baseline Characteristics
Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice
Baseline characteristics by cohort
| Measure |
Rheumatoid Arthritis
n=4208 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Gender
Female
|
3199 participants
n=5 Participants
|
|
Gender
Male
|
958 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4208 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) 28
Month 3 (n=2620)
|
-1.5 units on a scale
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score (DAS) 28
Month 6 (n=2243
|
-1.8 units on a scale
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score (DAS) 28
Month 9 (n=1877)
|
-1.9 units on a scale
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score (DAS) 28
Month 12 (n=1776)
|
-2.0 units on a scale
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score (DAS) 28
Month 18 (n=1519)
|
-2.1 units on a scale
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score (DAS) 28
Month 24 (n=1248)
|
-2.2 units on a scale
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
Clinical remission is defined as a disease activity score (DAS) 28 score of \< 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants in DAS28 Remission
Month 18 (n=1519)
|
29.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in DAS28 Remission
Month 3 (n=2620)
|
18.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in DAS28 Remission
Month 6 (n=2243)
|
22.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in DAS28 Remission
Month 9 (n=1877)
|
26.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in DAS28 Remission
Month 12 (n=1776)
|
27.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in DAS28 Remission
Month 24 (n=1248)
|
34.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Significant Therapeutic Response
Month 3 (n=2620)
|
38.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Significant Therapeutic Response
Month 6 (n=2243)
|
49.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Significant Therapeutic Response
Month 9 (n=1877)
|
54.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Significant Therapeutic Response
Month 12 (n=1776)
|
56.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Significant Therapeutic Response
Month 18 (n=1519)
|
60.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Significant Therapeutic Response
Month 24 (n=1248)
|
61.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 \>3.2 to ≤5.1; High disease activity as a DAS28 \>5.1.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
n=2620 Participants
3 months after inclusion
|
Month 6
n=2243 Participants
6 months after inclusion
|
Month 9
n=1877 Participants
9 months after inclusion
|
Month 12
n=1776 Participants
12 months after inclusion
|
Month 18
n=1519 Participants
18 months after inclusion
|
Month 24
n=1248 Participants
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Low, Moderate and High Disease Activity
Low disease activity
|
0.0 percentage of participants
|
30.2 percentage of participants
|
36.5 percentage of participants
|
41.8 percentage of participants
|
43.7 percentage of participants
|
46.7 percentage of participants
|
51.4 percentage of participants
|
|
Percentage of Participants With Low, Moderate and High Disease Activity
Moderate disease ctivity
|
35.7 percentage of participants
|
45.9 percentage of participants
|
45.6 percentage of participants
|
43.9 percentage of participants
|
43.1 percentage of participants
|
41.7 percentage of participants
|
37.7 percentage of participants
|
|
Percentage of Participants With Low, Moderate and High Disease Activity
High disease activity
|
64.3 percentage of participants
|
23.9 percentage of participants
|
17.9 percentage of participants
|
14.3 percentage of participants
|
13.2 percentage of participants
|
11.6 percentage of participants
|
10.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 0 (n=2900)
|
32.1 mm/hour
Standard Deviation 22.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 3 (n=2684)
|
23.2 mm/hour
Standard Deviation 20.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 6 (n=2259)
|
22.1 mm/hour
Standard Deviation 19.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 9 (n=1910)
|
21.6 mm/hour
Standard Deviation 18.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 12 (n=1805)
|
21.4 mm/hour
Standard Deviation 17.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 18 (n=1515)
|
21.0 mm/hour
Standard Deviation 17.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 24 (n=1263)
|
21.2 mm/hour
Standard Deviation 18.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
C-Reactive Protein (CRP) Levels Over Time
Month 0 (n=2899)
|
20.0 mg/L
Standard Deviation 36.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-Reactive Protein (CRP) Levels Over Time
Month 3 (n=2677)
|
11.9 mg/L
Standard Deviation 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-Reactive Protein (CRP) Levels Over Time
Month 9 (n=1936)
|
8.1 mg/L
Standard Deviation 15.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-Reactive Protein (CRP) Levels Over Time
Month 12 (n=1813)
|
8.0 mg/L
Standard Deviation 17.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-Reactive Protein (CRP) Levels Over Time
Month 6 (n=2289)
|
9.2 mg/L
Standard Deviation 19.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-Reactive Protein (CRP) Levels Over Time
Month 18 (n=1537)
|
6.6 mg/L
Standard Deviation 11.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-Reactive Protein (CRP) Levels Over Time
Month 24 (n=1297)
|
5.7 mg/L
Standard Deviation 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Tender Joint Count (TJC) Over Time
Month 0 (n=2950)
|
10.6 tender joints
Standard Deviation 6.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 3 (n=2778)
|
5.4 tender joints
Standard Deviation 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 6 (n=2393)
|
4.3 tender joints
Standard Deviation 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 9 (n=2010)
|
3.9 tender joints
Standard Deviation 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 12 (n=1886)
|
3.6 tender joints
Standard Deviation 5.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 18 (n=1621)
|
3.4 tender joints
Standard Deviation 4.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 24 (n=1339)
|
3.1 tender joints
Standard Deviation 4.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Swollen Joint Count (SJC) Over Time
Month 0 (n=2950)
|
7.7 swollen joints
Standard Deviation 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 3 (n=2768)
|
3.7 swollen joints
Standard Deviation 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 6 (n=2375)
|
3.0 swollen joints
Standard Deviation 4.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 9 (n=2003)
|
2.6 swollen joints
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 12 (n=1868)
|
2.4 swollen joints
Standard Deviation 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 18 (n=1609)
|
2.1 swollen joints
Standard Deviation 3.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 24 (n=1326)
|
2.0 swollen joints
Standard Deviation 3.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 9 (n=1997)
|
71.3 units on a scale
Standard Deviation 22.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 12 (n=1882)
|
71.9 units on a scale
Standard Deviation 22.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 18 (n=1623)
|
72.4 units on a scale
Standard Deviation 22.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 24 (n=1341)
|
72.7 units on a scale
Standard Deviation 22.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 0 (n=2938)
|
61.9 units on a scale
Standard Deviation 22.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 3 (n=2755)
|
68.4 units on a scale
Standard Deviation 22.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 6 (n=2369)
|
70.4 units on a scale
Standard Deviation 22.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18 and 24Population: Full analysis set with available data at each time point (indicated by n)
Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Patients Global Assessment of Disease Activity Over Time
Month 18 (n=1609)
|
4.0 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 24 (n=1339)
|
3.8 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 0 (n=2950)
|
6.3 cm
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 3 (n=2731)
|
4.7 cm
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 6 (n=2353)
|
4.4 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 9 (n=1975)
|
4.2 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 12 (n=1869)
|
4.1 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Participants Assessment of Fatigue Over Time
Month 0 (n=2940)
|
5.8 cm
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 3 (n=2727)
|
4.5 cm
Standard Deviation 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 6 (n=2351)
|
4.2 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 9 (n=1976)
|
4.0 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 12 (n=1864)
|
4.0 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 18 (n=1608)
|
3.9 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 24 (n=1335)
|
3.7 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Participants Assessment of Pain Over Time
Month 0 (n=2942)
|
6.4 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 3 (n=2732)
|
4.5 cm
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 6 (n=2356)
|
4.2 cm
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 9 (n=1973)
|
4.1 cm
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 12 (n=1866)
|
3.9 cm
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 18 (n=1609)
|
3.9 cm
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 24 (n=1339)
|
3.7 cm
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 18, and 24Population: Full analysis set with available data at each time point
Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2864 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
n=2648 Participants
3 months after inclusion
|
Month 6
n=2288 Participants
6 months after inclusion
|
Month 9
n=1914 Participants
9 months after inclusion
|
Month 12
n=1513 Participants
12 months after inclusion
|
Month 18
n=1302 Participants
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Impairment in Daily Activities
No days of impairment
|
19.7 percentage of participants
|
35.8 percentage of participants
|
40.3 percentage of participants
|
45.7 percentage of participants
|
51.4 percentage of participants
|
52.1 percentage of participants
|
—
|
|
Percentage of Participants With Impairment in Daily Activities
Less than 7 days of impairment
|
28.5 percentage of participants
|
36.3 percentage of participants
|
35.5 percentage of participants
|
33.3 percentage of participants
|
30.0 percentage of participants
|
30.4 percentage of participants
|
—
|
|
Percentage of Participants With Impairment in Daily Activities
7 to 14 days of impairment
|
28.8 percentage of participants
|
16.1 percentage of participants
|
14.9 percentage of participants
|
13.2 percentage of participants
|
12.0 percentage of participants
|
10.8 percentage of participants
|
—
|
|
Percentage of Participants With Impairment in Daily Activities
More than 14 days of impairment
|
23.0 percentage of participants
|
11.7 percentage of participants
|
9.4 percentage of participants
|
7.8 percentage of participants
|
6.7 percentage of participants
|
6.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 6, 12, 18, and 24Population: Full analysis set participants who were employed and with available data at each time point (indicated by n)
Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 0 (n=1168)
|
20.6 days
Standard Deviation 52.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 6 (n=938)
|
9.9 days
Standard Deviation 33.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 12 (n=728)
|
4.4 days
Standard Deviation 21.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 18 (n=604)
|
5.2 days
Standard Deviation 27.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 24 (n=507)
|
3.8 days
Standard Deviation 17.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 6, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 9
9 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With In-patient Hospitalization
Baseline (n=2893)
|
21.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 6 (n=2293)
|
7.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 12 (n=1844)
|
5.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 18 (n=1584)
|
5.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 24 (n=1320)
|
3.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Full analysis set with available data at each time point (indicated by n)
Outcome measures
| Measure |
Rheumatoid Arthritis
n=2950 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
Month 3
n=2820 Participants
3 months after inclusion
|
Month 6
n=2415 Participants
6 months after inclusion
|
Month 9
n=2041 Participants
9 months after inclusion
|
Month 12
n=1917 Participants
12 months after inclusion
|
Month 18
n=1651 Participants
18 months after inclusion
|
Month 24
n=1372 Participants
24 months after inclusion
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Non-steroidal anti-inflammatory drug
|
46.1 percentage of participants
|
36.9 percentage of participants
|
34.2 percentage of participants
|
33.9 percentage of participants
|
32.7 percentage of participants
|
31.7 percentage of participants
|
30.5 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Methotrexate
|
54.0 percentage of participants
|
52.3 percentage of participants
|
53.2 percentage of participants
|
53.1 percentage of participants
|
53.2 percentage of participants
|
52.9 percentage of participants
|
51.0 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Sulfasalazine
|
6.2 percentage of participants
|
3.7 percentage of participants
|
3.6 percentage of participants
|
3.2 percentage of participants
|
3.5 percentage of participants
|
3.3 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Hydroxychloroquine/Chloroquine
|
2.5 percentage of participants
|
2.0 percentage of participants
|
1.6 percentage of participants
|
1.2 percentage of participants
|
1.2 percentage of participants
|
1.3 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Leflunomide
|
22.1 percentage of participants
|
18.0 percentage of participants
|
15.9 percentage of participants
|
15.3 percentage of participants
|
15.0 percentage of participants
|
14.1 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Other disease-modifying antirheumatic drug
|
4.5 percentage of participants
|
2.8 percentage of participants
|
2.5 percentage of participants
|
2.3 percentage of participants
|
2.0 percentage of participants
|
2.2 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Analgesics
|
21.8 percentage of participants
|
15.4 percentage of participants
|
14.9 percentage of participants
|
14.0 percentage of participants
|
12.9 percentage of participants
|
11.7 percentage of participants
|
12.0 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Cyclo-oxygenase 2 (COX-2) Inhibitors
|
12.4 percentage of participants
|
10.4 percentage of participants
|
10.2 percentage of participants
|
9.6 percentage of participants
|
9.2 percentage of participants
|
9.6 percentage of participants
|
9.7 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Systemic glucocorticoids
|
80.9 percentage of participants
|
73.4 percentage of participants
|
69.1 percentage of participants
|
65.7 percentage of participants
|
62.1 percentage of participants
|
58.8 percentage of participants
|
57.4 percentage of participants
|
Adverse Events
Rheumatoid Arthritis
Serious events: 245 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rheumatoid Arthritis
n=4208 participants at risk
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.26%
11/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Pneumonia
|
0.24%
10/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Bronchitis
|
0.14%
6/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Urinary tract infection
|
0.12%
5/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Herpes zoster
|
0.10%
4/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Oral herpes
|
0.10%
4/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Bronchopneumonia
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Cellulitis
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Laryngitis
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Rash pustular
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Sinusitis
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Gastrointestinal infection
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Infection
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Localized infection
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Respiratory tract infection
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Sepsis
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Tonsillitis
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Abscess limb
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Acute tonsillitis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Chronic sinusitis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Device-related infection
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Diverticulitis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Encephalitis viral
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Fungal infection
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Furuncle
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Gastroenteritis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Genital herpes
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Herpes simplex
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Herpes virus infection
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Infection susceptibility increased
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Mastoiditis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Otitis media
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Pyothorax
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Sinobronchitis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Skin infection
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Staphylococcal infection
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Tooth abscess
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Infection site erythema
|
0.26%
11/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Injection site pruritus
|
0.21%
9/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Injection site reaction
|
0.12%
5/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Unevaluable event
|
0.12%
5/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Pyrexia
|
0.10%
4/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Injection site pain
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Edema
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Fatigue
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Inflammation
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Injection site swelling
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Injection site urticaria
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Adverse drug reaction
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Chills
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Condition aggravated
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Death
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Disease recurrence
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Injection site induration
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Injection site scab
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Local swelling
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Malaise
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Mucosal dryness
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Obstruction
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
General disorders
Peripheral edema
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.24%
10/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.14%
6/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.12%
5/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.10%
4/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.33%
14/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.17%
7/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Nausea
|
0.12%
5/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Diarrhea
|
0.10%
4/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Stomatitis
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Vomiting
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Acute abdomen
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Gastritis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Glossodynia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Hematochezia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Hypoesthesia oral
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Mouth edema
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Oral pain
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Swollen tongue
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Tongue blistering
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Gastrointestinal disorders
Tongue disorder
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Hospitalization
|
0.14%
6/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.10%
4/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Synovectomy
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Injection
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Surgery
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Antibiotic therapy
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Arthrodesis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Esophageal operation
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Mastoid operation
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Mastoidectomy
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Sinus operation
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Spinal operation
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Stent placement
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Therapy cessation
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Surgical and medical procedures
Vertebroplasty
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Dizziness
|
0.14%
6/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Headache
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Somnolence
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Anosmia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Aphasia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Hypogeusia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Neuralgia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Neurological symptom
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Polyneuropathy
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Nervous system disorders
Transient ischemic attack
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Cardiac failure
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Tachycardia
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Angina pectoris
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Myocardial infarction
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Palpitations
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Atrial tachycardia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Pericardial effusion
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Bloody airway discharge
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine cancer
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary tumor of renal pelvis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urteric cancer local
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Eye disorders
Eyelid edema
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Eye disorders
Cataract
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Eye disorders
Eyelid exfoliation
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Eye disorders
Eyelids pruritus
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Eye disorders
Visual acuity reduced
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Eye disorders
Xerophthalmia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Investigations
Arthroscopy
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Investigations
Antinuclar antibody positive
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Investigations
Arteriogram coronary
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Investigations
DNA antibody positive
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Investigations
Electrophoresis protein abnormal
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Investigations
Hepatic enzyme increased
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Investigations
Transaminase increased
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Psychiatric disorders
Anxiety
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Psychiatric disorders
Restlessness
|
0.05%
2/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Psychiatric disorders
Insomnia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Psychiatric disorders
Panic reaction
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Psychiatric disorders
Sleep disorder
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Renal and urinary disorders
Bladder tamponade
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Renal and urinary disorders
Chromaturia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Renal and urinary disorders
Cystitis hemorrhagic
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Renal and urinary disorders
Micturition urgency
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Renal and urinary disorders
Nephritis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Vascular disorders
Hypertension
|
0.07%
3/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Vascular disorders
Flushing
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Vascular disorders
Venous thrombosis
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Vascular disorders
Venous thrombosis limb
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Blood and lymphatic system disorders
Anemia hemolytic autoimmune
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Immune system disorders
Hypersensitivity
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.02%
1/4208 • Adverse events (AEs) were collected throughout the 24-month period.
During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER