Trial Outcomes & Findings for Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT00195676)
NCT ID: NCT00195676
Last Updated: 2011-04-13
Results Overview
The Physician's Global Assessment \[PGA\] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1469 participants
Primary outcome timeframe
Week 16 of Period R
Results posted on
2011-04-13
Participant Flow
Participant milestones
| Measure |
All Adalimumab Treatment
All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
|
|---|---|
|
Period O - Open-label Treatment
STARTED
|
1468
|
|
Period O - Open-label Treatment
COMPLETED
|
862
|
|
Period O - Open-label Treatment
NOT COMPLETED
|
606
|
|
Period W (Withdrawal) - No Treatment
STARTED
|
608
|
|
Period W (Withdrawal) - No Treatment
COMPLETED
|
0
|
|
Period W (Withdrawal) - No Treatment
NOT COMPLETED
|
608
|
|
Period R - Retreatment 16 Weeks
STARTED
|
525
|
|
Period R - Retreatment 16 Weeks
COMPLETED
|
490
|
|
Period R - Retreatment 16 Weeks
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
All Adalimumab Treatment
All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
|
|---|---|
|
Period O - Open-label Treatment
Adverse Event
|
82
|
|
Period O - Open-label Treatment
Death
|
6
|
|
Period O - Open-label Treatment
Lack of Efficacy
|
198
|
|
Period O - Open-label Treatment
Lost to Follow-up
|
91
|
|
Period O - Open-label Treatment
Protocol Violation
|
12
|
|
Period O - Open-label Treatment
Withdrawal by Subject
|
147
|
|
Period O - Open-label Treatment
Administrative reasons
|
2
|
|
Period O - Open-label Treatment
Other reasons
|
68
|
|
Period W (Withdrawal) - No Treatment
Adverse Event
|
4
|
|
Period W (Withdrawal) - No Treatment
Death
|
2
|
|
Period W (Withdrawal) - No Treatment
Lost to Follow-up
|
11
|
|
Period W (Withdrawal) - No Treatment
Withdrawal by Subject
|
46
|
|
Period W (Withdrawal) - No Treatment
Relapse (PGA >= 3)
|
397
|
|
Period W (Withdrawal) - No Treatment
Period W Close-out
|
129
|
|
Period W (Withdrawal) - No Treatment
Administrative reasons
|
1
|
|
Period W (Withdrawal) - No Treatment
Other reasons
|
18
|
|
Period R - Retreatment 16 Weeks
Adverse Event
|
4
|
|
Period R - Retreatment 16 Weeks
Lack of Efficacy
|
5
|
|
Period R - Retreatment 16 Weeks
Lost to Follow-up
|
11
|
|
Period R - Retreatment 16 Weeks
Withdrawal by Subject
|
9
|
|
Period R - Retreatment 16 Weeks
Other reasons
|
6
|
Baseline Characteristics
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
All Adalimumab Treatment
n=1468 Participants
All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
|
|---|---|
|
Age Continuous
|
44.1 years
STANDARD_DEVIATION 12.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
470 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
998 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
802 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
501 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
15 participants
n=5 Participants
|
|
Region of Enrollment
France
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16 of Period RPopulation: The Period R Modified Intent-to-Treat population included 178 participants who relapsed and 107 participants who did not relapse in Period W when therapy was withdrawn; all received Period R adalimumab 40 mg every other week (after an 80 mg initial dose). Results were analyzed using non-responder imputation (NRI) for missing values.
The Physician's Global Assessment \[PGA\] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
Outcome measures
| Measure |
Period O Adalimumab EOW Treatment Population
n=285 Participants
Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
|
|---|---|
|
Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R
|
76.5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 60Population: A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.
The Physician's Global Assessment \[PGA\] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
Outcome measures
| Measure |
Period O Adalimumab EOW Treatment Population
n=1256 Participants
Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
|
|---|---|
|
Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60
|
50.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 120Population: A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.
The Physician's Global Assessment \[PGA\] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
Outcome measures
| Measure |
Period O Adalimumab EOW Treatment Population
n=1256 Participants
Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
|
|---|---|
|
Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120
|
46.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 60Population: A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.
Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.
Outcome measures
| Measure |
Period O Adalimumab EOW Treatment Population
n=1256 Participants
Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
|
|---|---|
|
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60
|
61.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 120Population: A subset of the the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.
Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.
Outcome measures
| Measure |
Period O Adalimumab EOW Treatment Population
n=1256 Participants
Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
|
|---|---|
|
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120
|
57.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Period WPopulation: Participants in the Period W Modified Intent-to-Treat Population who had relapsed (defined by a PGA of greater than or equal to 3) during Period W and had at least one post-baseline PGA assessment in Period W.
Relapse of psoriasis was defined as a Physician's Global Assessment (assessment of overall lesion severity) score of greater than or equal to 3 (3=moderate; 4=severe; 5=very severe).
Outcome measures
| Measure |
Period O Adalimumab EOW Treatment Population
n=339 Participants
Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
|
|---|---|
|
Time to Relapse in Period W
|
141 days
Interval 127.0 to 146.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 16 of Period RPopulation: Participants in the Period R mITT population who had relapsed (had a PGA of greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.
The Physician's Global Assessment \[PGA\] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
Outcome measures
| Measure |
Period O Adalimumab EOW Treatment Population
n=178 Participants
Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
|
|---|---|
|
Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R
|
69.1 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 16 of Period RPopulation: Participants in the Period R mITT population who did not relapse (did not have a PGA greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.
The Physician's Global Assessment \[PGA\] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
Outcome measures
| Measure |
Period O Adalimumab EOW Treatment Population
n=107 Participants
Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
|
|---|---|
|
Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R
|
88.8 percentage of participants
|
Adverse Events
All Adalimumab Treatment
Serious events: 189 serious events
Other events: 1036 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Adalimumab Treatment
n=1468 participants at risk
All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
|
|---|---|
|
Reproductive system and breast disorders
Breast enlargement
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Reproductive system and breast disorders
Cystocele
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.27%
4/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Reproductive system and breast disorders
Perineal fistula
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Arrhythmia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Cardiac arrest
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Cardiac tamponade
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Coronary artery disease
|
0.68%
10/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Myocardial infarction
|
0.34%
5/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Ascites
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Diverticulum
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Enterocele
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Nausea
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
General disorders
Chest discomfort
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
General disorders
Chest pain
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
General disorders
Localised oedema
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
General disorders
Oedema peripheral
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Hepatobiliary disorders
Colecystitis
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Abscess
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Abscess limb
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Appendicitis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Appendicitis perforated
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Arthritis bacterial
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Cellulitis
|
0.41%
6/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Diverticulitis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Epiglottitis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Gastroenteritis
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Gastroenteritis escherichia coli
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Gastroenteritis viral
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Haematoma infection
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Hepatitis C
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Human ehrlichiosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Lobar pneumonia
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Meningitis viral
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Necrotising pasciitis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Osteomyelitis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Paratyphoid fever
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Peritonsillar abscess
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Pneumonia
|
0.34%
5/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Pneumonia legionella
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Post procedural infection
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Pyelonephritis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Sepsis
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Staphylococcal abscess
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Staphylococcal infection
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Streptococcal infection
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Subcutaneous abscess
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Tuberculosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Device failure
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Injury
|
0.27%
4/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Postprocedural haemorrhage
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Metabolism and nutrition disorders
Central obesity
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Metabolism and nutrition disorders
Obesity
|
0.27%
4/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.48%
7/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenoma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.54%
8/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Agnosia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Brain mass
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Convulsion
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Diabetic ketoacidotic hyperglycaemic coma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Neuralgia
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Paresis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Presyncope
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Syncope
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Cerebellar infarction
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Psychiatric disorders
Anxiety
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Psychiatric disorders
Completed suicide
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Psychiatric disorders
Cyclothymic disorder
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Psychiatric disorders
Depression
|
0.27%
4/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Psychiatric disorders
Depression suicidal
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Psychiatric disorders
Psychotic disorder
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.34%
5/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Renal and urinary disorders
Renal colic
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Renal and urinary disorders
Renal failure
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Renal and urinary disorders
Renal failure acute
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Renal and urinary disorders
Urinary retention
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Reproductive system and breast disorders
Bartholinitis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Reproductive system and breast disorders
Rectocele
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Skin and subcutaneous tissue disorders
Excessive skin
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Social circumstances
Physical abuse
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Surgical and medical procedures
Abortion induced
|
0.20%
3/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Vascular disorders
Aortic aneurysm
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Vascular disorders
Aortic stenosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Vascular disorders
Arterial stenosis
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Vascular disorders
Deep vein thrombosis
|
0.14%
2/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Vascular disorders
Haemorrhage
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Vascular disorders
Orthostatic hypotension
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Vascular disorders
Venous insufficiency
|
0.07%
1/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
Other adverse events
| Measure |
All Adalimumab Treatment
n=1468 participants at risk
All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
83/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
82/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
General disorders
Injection site reaction
|
5.0%
74/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Bronchitis
|
7.9%
116/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Influenza
|
7.7%
113/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Nasopharyngitis
|
26.6%
391/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Sinusitis
|
10.2%
150/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.3%
298/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.7%
84/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
156/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
110/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
75/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Nervous system disorders
Headache
|
11.2%
164/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
94/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
81/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
|
Vascular disorders
Hypertension
|
11.1%
163/1468 • 2,095 days(approximately 5.7 years), including adalimumab exposure in prior studies
Adverse events reported from the start of adalimumab treatment until 70 days after discontinuation of adalimumab treatment were defined as treatment-emergent and are displayed.
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER