Trial Outcomes & Findings for Adalimumab in Adult Japanese Subjects With Psoriasis (NCT NCT00647400)
NCT ID: NCT00647400
Last Updated: 2011-04-08
Results Overview
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
147 participants
Primary outcome timeframe
Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
Results posted on
2011-04-08
Participant Flow
Japanese participants with chronic plaque psoriasis who completed the blinded, placebo-controlled Study M04-688 (NCT00338754; 24-week duration) enrolled in the extension study, M04-702, an open-label study until adalimumab received approval for treatment of psoriasis in Japan.
Participant milestones
| Measure |
Adalimumab 40 mg Every Other Week
Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
|
Adalimumab 80 mg Every Other Week
Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
58
|
|
Overall Study
COMPLETED
|
67
|
45
|
|
Overall Study
NOT COMPLETED
|
22
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adalimumab in Adult Japanese Subjects With Psoriasis
Baseline characteristics by cohort
| Measure |
Adalimumab 40 mg Every Other Week
n=89 Participants
Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
|
Adalimumab 80 mg Every Other Week
n=58 Participants
Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age Continuous
|
45.1 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 11.88 • n=7 Participants
|
44.2 years
STANDARD_DEVIATION 12.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
89 participants
n=5 Participants
|
58 participants
n=7 Participants
|
147 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumabPopulation: All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Outcome measures
| Measure |
Adalimumab 40 mg Every Other Week
n=89 Participants
Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
|
Adalimumab 80 mg Every Other Week
n=58 Participants
Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
|
|---|---|---|
|
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow])
|
80 Participants
|
55 Participants
|
|
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow])
|
79 Participants
|
52 Participants
|
|
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow])
|
29 Participants
|
14 Participants
|
|
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow])
|
78 Participants
|
54 Participants
|
|
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow])
|
80 Participants
|
51 Participants
|
|
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow])
|
76 Participants
|
52 Participants
|
|
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow])
|
75 Participants
|
49 Participants
|
|
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow])
|
71 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumabPopulation: All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Outcome measures
| Measure |
Adalimumab 40 mg Every Other Week
n=89 Participants
Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
|
Adalimumab 80 mg Every Other Week
n=58 Participants
Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
|
|---|---|---|
|
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow])
|
54 Participants
|
45 Participants
|
|
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow])
|
69 Participants
|
50 Participants
|
|
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow])
|
65 Participants
|
51 Participants
|
|
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow])
|
67 Participants
|
48 Participants
|
|
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow])
|
70 Participants
|
47 Participants
|
|
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow])
|
69 Participants
|
41 Participants
|
|
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow])
|
27 Participants
|
13 Participants
|
|
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow])
|
66 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumabPopulation: All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Outcome measures
| Measure |
Adalimumab 40 mg Every Other Week
n=89 Participants
Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
|
Adalimumab 80 mg Every Other Week
n=58 Participants
Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
|
|---|---|---|
|
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow])
|
54 Participants
|
44 Participants
|
|
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow])
|
55 Participants
|
38 Participants
|
|
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow])
|
55 Participants
|
35 Participants
|
|
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow])
|
57 Participants
|
33 Participants
|
|
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow])
|
31 Participants
|
29 Participants
|
|
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow])
|
50 Participants
|
39 Participants
|
|
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow])
|
54 Participants
|
42 Participants
|
|
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow])
|
23 Participants
|
12 Participants
|
Adverse Events
Adalimumab 40 mg Every Other Week
Serious events: 19 serious events
Other events: 88 other events
Deaths: 0 deaths
Adalimumab 80 mg Every Other Week
Serious events: 11 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab 40 mg Every Other Week
n=89 participants at risk
Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
|
Adalimumab 80 mg Every Other Week
n=58 participants at risk
Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Cardiac disorders
Angina pectoris
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Oedema peripheral
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Bronchopneumonia
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Cellulitis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Viral infection
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Near drowning
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Nervous system disorders
Cerebral infarction
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Nervous system disorders
Loss of consciousness
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Nervous system disorders
Monoplegia
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Reproductive system and breast disorders
Epididymitis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Social circumstances
Miscarriage of partner
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
Other adverse events
| Measure |
Adalimumab 40 mg Every Other Week
n=89 participants at risk
Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
|
Adalimumab 80 mg Every Other Week
n=58 participants at risk
Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Cardiac disorders
Palpitations
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Eye disorders
Conjunctivitis
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
12.1%
7/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
4/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Cheilitis
|
3.4%
3/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Constipation
|
3.4%
3/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.5%
20/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
24.1%
14/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Gastritis
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Gingival pain
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Periodontitis
|
10.1%
9/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
10.3%
6/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Toothace
|
10.1%
9/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
3/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Adverse drug reaction
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
17.2%
10/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Chest pain
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Feeling abnormal
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Injection site erythema
|
18.0%
16/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Injection site pruritus
|
4.5%
4/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Injection site reaction
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Injection site swelling
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Malaise
|
13.5%
12/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
13.8%
8/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Oedema peripheral
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Pain
|
4.5%
4/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Pyrexia
|
13.5%
12/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
12.1%
7/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
General disorders
Swelling
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Hepatobiliary disorders
Hepatic steatotis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Immune system disorders
Seasonal allergy
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Cystitis
|
3.4%
3/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Dental caries
|
20.2%
18/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
10.3%
6/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Folliculitis
|
23.6%
21/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
24.1%
14/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Furuncle
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Herpes simplex
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Hordeolum
|
4.5%
4/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Nasopharyngitis
|
75.3%
67/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
77.6%
45/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Otitis media
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Pharyngitis
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
12.1%
7/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Rhinitis
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Tinea pedis
|
10.1%
9/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
15.5%
9/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.7%
14/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
15.5%
9/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
11.2%
10/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.1%
9/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Alanine aminotransferase increased
|
23.6%
21/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
15.5%
9/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Antinuclear antibody increased
|
23.6%
21/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
13.8%
8/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Aspartate aminotransferase increased
|
16.9%
15/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
10.3%
6/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Bacteria urine identified
|
9.0%
8/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Blood bilirubin increased
|
10.1%
9/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Blood creatine phosphokinase increased
|
23.6%
21/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
25.9%
15/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Blood glucose increased
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
10.3%
6/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.0%
8/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Blood triglycerides increased
|
24.7%
22/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
29.3%
17/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Blood uric acid increased
|
14.6%
13/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
19.0%
11/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Blood urine present
|
13.5%
12/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
C-reactive protein increased
|
13.5%
12/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Eosinophil percentage increased
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.4%
11/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Glucose urine present
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Platelet count decreased
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Platelet count increased
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Protein urine present
|
4.5%
4/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Weight decreased
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
Weight increased
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
White blood cell count increased
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Investigations
White blood cells urine positive
|
10.1%
9/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
11.2%
10/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
13.8%
8/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.1%
17/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
13.8%
8/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.3%
19/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
17.2%
10/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.4%
3/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.5%
4/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.4%
11/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
3.4%
2/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
4.5%
4/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Nervous system disorders
Dizziness
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Nervous system disorders
Headache
|
21.3%
19/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
13.8%
8/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Nervous system disorders
Hypoaesthesia
|
4.5%
4/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Psychiatric disorders
Insomnia
|
11.2%
10/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
15.5%
9/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.5%
12/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
13.8%
8/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
1.7%
1/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
20.2%
18/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
17.2%
10/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
5/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
0.00%
0/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.4%
3/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
18.0%
16/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
13.8%
8/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.0%
8/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
10.3%
6/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.2%
10/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
17.2%
10/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
15.5%
9/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
15.5%
9/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis
|
1.1%
1/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
6.9%
4/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.2%
2/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
10.3%
6/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Skin and subcutaneous tissue disorders
Urticaria generalised
|
0.00%
0/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
5.2%
3/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Vascular disorders
Hypertension
|
6.7%
6/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
|
Infections and infestations
Influenza
|
7.9%
7/89 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
8.6%
5/58 • Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.
|
Additional Information
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