Trial Outcomes & Findings for Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease (NCT NCT00195715)
NCT ID: NCT00195715
Last Updated: 2011-07-12
Results Overview
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
777 participants
Primary outcome timeframe
Week 156
Results posted on
2011-07-12
Participant Flow
Participant milestones
| Measure |
Open-label Adalimumab
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Overall Study
STARTED
|
777
|
|
Overall Study
COMPLETED
|
400
|
|
Overall Study
NOT COMPLETED
|
377
|
Reasons for withdrawal
| Measure |
Open-label Adalimumab
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Overall Study
Adverse Event
|
122
|
|
Overall Study
Withdrawal by Subject
|
58
|
|
Overall Study
Lost to Follow-up
|
27
|
|
Overall Study
Protocol Violation
|
13
|
|
Overall Study
Lack of Efficacy
|
93
|
|
Overall Study
Pregnancy
|
14
|
|
Overall Study
Investigative site closure
|
8
|
|
Overall Study
Subject moved/relocated
|
7
|
|
Overall Study
Subject non-compliance
|
6
|
|
Overall Study
Subject started commercial Humira
|
5
|
|
Overall Study
Subject choice
|
3
|
|
Overall Study
Loss of response/no improvement
|
3
|
|
Overall Study
Sponsor stopped study
|
1
|
|
Overall Study
Administrative reasons
|
2
|
|
Overall Study
Investigator's decision
|
2
|
|
Overall Study
Subject wants to get pregnant
|
4
|
|
Overall Study
Use of prohibited medication
|
2
|
|
Overall Study
Planned surgery
|
2
|
|
Overall Study
Increased infection rate
|
1
|
|
Overall Study
Ineligible
|
1
|
|
Overall Study
Colonic stricture
|
1
|
|
Overall Study
Sponsor discontinued trial
|
1
|
|
Overall Study
Sponsor discretion - trial ended early
|
1
|
Baseline Characteristics
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
Baseline characteristics by cohort
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Age Continuous
|
38.0 years
STANDARD_DEVIATION 11.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
485 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
292 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
349 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
66 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
197 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
18 participants
n=5 Participants
|
|
Region of Enrollment
France
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 156Population: Intent-to-treat, defined as all subjects who received at least 1 dose of study drug; Observed Cases
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Outcome measures
| Measure |
Open-label Adalimumab
n=272 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects Achieving Clinical Remission
|
69.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Intent-to-treat, Observed Cases
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Outcome measures
| Measure |
Open-label Adalimumab
n=609 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects Achieving Clinical Remission
|
59.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 108Population: Intent-to-treat, Observed Cases
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Outcome measures
| Measure |
Open-label Adalimumab
n=462 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects Achieving Clinical Remission
|
68.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 204Population: Intent-to-treat, Observed Cases
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Outcome measures
| Measure |
Open-label Adalimumab
n=15 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects Achieving Clinical Remission
|
46.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 156Population: Intent-to-treat, Observed Cases
A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Outcome measures
| Measure |
Open-label Adalimumab
n=272 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects Achieving Clinical Response 100 (CR-100)
|
85.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 156Population: Intent-to-treat, Observed Cases
A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Outcome measures
| Measure |
Open-label Adalimumab
n=272 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects Achieving Clinical Response 70 (CR-70)
|
91.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 156Population: Intent-to-treat, Subjects with steroid use at baseline of preceding study, Observed Cases
Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of \<150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Outcome measures
| Measure |
Open-label Adalimumab
n=103 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects Achieving Steroid-free Clinical Remission
|
63.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 156Population: Intent-to-treat, Subjects with corticosteroid use at baseline of preceding study, Observed Cases
Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Outcome measures
| Measure |
Open-label Adalimumab
n=103 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects Achieving Steroid-free CR-100
|
74.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 156Population: Intent-to-treat, Subjects with fistulas present at baseline of the preceding study, Observed Cases
Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.
Outcome measures
| Measure |
Open-label Adalimumab
n=43 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Fistula Remission
|
55.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population, defined as all subjects who received at least 1 dose of study drug
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Infection
|
80.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Serious Infection
|
10.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Malignancy
|
4.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Lymphoma
|
0.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Nonmelanoma Skin Cancer
|
1.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)
|
2.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)
|
2.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
An injection site reaction is any adverse event corresponding to a preferred term beginning with "injection site" excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration.
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Injection Site Reaction-related Adverse Event
|
22.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)
|
4.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Congestive Heart Failure
|
0 Percentage of subjects
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Demyelinating Disease
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Hepatic-related Adverse Event
|
8.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Allergic Reaction-related Adverse Event
|
2.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Lupus-like Syndrome
|
0.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Hematologic-related Adverse Event
|
1.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 262 weeks of adalimumab treatmentPopulation: Safety population
Outcome measures
| Measure |
Open-label Adalimumab
n=777 Participants
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Percentage of Subjects With Fatal Adverse Event
|
0.3 Percentage of participants
|
Adverse Events
Open-label Adalimumab
Serious events: 296 serious events
Other events: 720 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label Adalimumab
n=777 participants at risk
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Infections and infestations
Abdominal abscess
|
0.64%
5/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Abdominal mass
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
11/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Abdominal sepsis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Surgical and medical procedures
Abortion induced
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion of ectopic pregnancy
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Abscess
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Abscess intestinal
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Abscess limb
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Acute pulmonary histoplasmosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
4/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Anal abscess
|
1.9%
15/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Anal fistula
|
1.0%
8/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Anal stenosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Cardiac disorders
Angina unstable
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Anxiety
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Appendicitis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Arthritis infective
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Ascites
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Vascular disorders
Axillary vein thrombosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Endocrine disorders
Basedow's disease
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Bipolar disorder
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Renal and urinary disorders
Bladder prolapse
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Breast cellulitis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Bronchitis
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Investigations
C-reactive protein increased
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Renal and urinary disorders
Calculus ureteric
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Campylobacter infection
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Carotid artery disease
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Catheter sepsis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Cellulitis
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Cervicitis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Chest pain
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Chills
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Clostridial infection
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Coccidioidomycosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Colitis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Colpocele
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Constipation
|
0.51%
4/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Convulsion
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Crohn's disease
|
11.8%
92/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Cystocele
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.90%
7/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Demyelination
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Dental caries
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Depression
|
0.64%
5/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Drug dependence
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Endometriosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Enteritis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Escherichia infection
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Faecal volume increased
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Fatigue
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Feeling cold
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Gastroenteritis
|
0.64%
5/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Gastroenteritis viral
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Endocrine disorders
Goitre
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Investigations
Haematocrit decreased
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Investigations
Haemoglobin decreased
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Headache
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Hernia
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Herpes zoster
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Immune system disorders
Hypersensitivity
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Vascular disorders
Hypertension
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Hypoaesthesia
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Vascular disorders
Hypotension
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Ileal perforation
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.51%
4/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Ileus
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Injury
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Insomnia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.3%
10/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Lobar pneumonia
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Surgical and medical procedures
Mammoplasty
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Surgical and medical procedures
Medical device removal
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Megacolon
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Muscle abscess
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Nausea
|
0.77%
6/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.77%
6/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Non-cardiac chest pain
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Obstruction
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Optic neuritis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Otitis media
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.64%
5/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Pain
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Cardiac disorders
Palpitations
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Perineal abscess
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Peripheral coldness
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Perirectal abscess
|
0.64%
5/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Peritonitis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Peritonsillar abscess
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Eye disorders
Photophobia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Social circumstances
Physical assault
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Pneumonia
|
1.0%
8/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Pneumonia fungal
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Post procedural infection
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Proctalgia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Pyelonephritis
|
0.64%
5/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Pyrexia
|
0.77%
6/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Rectal abscess
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Rectocele
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Renal and urinary disorders
Renal failure acute
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Scrotal abscess
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Sepsis
|
0.51%
4/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Septic shock
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Sinusitis
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.9%
30/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Staphylococcal infection
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Substance abuse
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Suicide attempt
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Cardiac disorders
Tachyarrhythmia
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Urinary tract infection
|
0.39%
3/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Investigations
Urogram normal
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal cancer recurrent
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.26%
2/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Vascular disorders
Venous thrombosis
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Viral infection
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Eye disorders
Vision blurred
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Eye disorders
Visual impairment
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
6/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Vulval abscess
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Investigations
Weight decreased
|
0.13%
1/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
Other adverse events
| Measure |
Open-label Adalimumab
n=777 participants at risk
40 mg by subcutaneous injection every other week or every week
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.4%
65/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Abdominal pain
|
23.2%
180/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
45/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
5.8%
45/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
46/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Anal fistula
|
5.8%
45/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Anxiety
|
6.9%
54/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.7%
192/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.2%
87/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Bronchitis
|
11.8%
92/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Constipation
|
10.4%
81/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
82/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Crohn's disease
|
39.8%
309/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Depression
|
9.0%
70/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Diarrhoea
|
15.2%
118/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Dizziness
|
6.9%
54/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
64/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.7%
52/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Fatigue
|
13.8%
107/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
5.1%
40/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
44/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Gastroenteritis
|
7.5%
58/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Gastroenteritis viral
|
5.4%
42/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.9%
54/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Nervous system disorders
Headache
|
18.1%
141/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Vascular disorders
Hypertension
|
5.7%
44/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Influenza
|
17.6%
137/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Influenza like illness
|
6.2%
48/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Injection site irritation
|
5.9%
46/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Injection site pain
|
5.5%
43/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Injection site reaction
|
7.7%
60/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Psychiatric disorders
Insomnia
|
10.4%
81/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.5%
43/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Nasopharyngitis
|
26.1%
203/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Nausea
|
18.3%
142/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Oedema peripheral
|
6.0%
47/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.8%
84/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Pain
|
5.8%
45/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
47/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.4%
50/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
General disorders
Pyrexia
|
13.5%
105/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.9%
100/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Sinusitis
|
14.9%
116/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Upper respiratory tract infection
|
19.3%
150/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Urinary tract infection
|
10.3%
80/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Infections and infestations
Viral infection
|
5.1%
40/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
82/777 • Up to 262 weeks of adalimumab treatment (includes adalimumab treatment in previous study)
|
Additional Information
Global Medical Services
Abbott
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Any investigator or institution that plans on presenting/publishing results disclosure, should provide written notification to Abbott within 60 days of their presentation/publication. Abbott requests that no presentation/publication will be allowed until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay of any proposed presentation/publication maybe requested if Abbott needs to secure patent or other proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER