Trial Outcomes & Findings for Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation) (NCT NCT01960790)
NCT ID: NCT01960790
Last Updated: 2019-03-22
Results Overview
The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.
Recruitment status
COMPLETED
Target enrollment
473 participants
Primary outcome timeframe
Up to Week 156
Results posted on
2019-03-22
Participant Flow
A total of 473 participants were enrolled in the study; 462 participants were analyzed for safety and 383 participants were analyzed for efficacy.
Participant milestones
| Measure |
Participants Who Received Humira®
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Overall Study
STARTED
|
473
|
|
Overall Study
COMPLETED
|
462
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Participants Who Received Humira®
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Overall Study
Survey forms could not be recovered
|
3
|
|
Overall Study
Treat with Humira outside survey period
|
3
|
|
Overall Study
Transferred to another hospital
|
4
|
|
Overall Study
Unevaluable for safety
|
1
|
Baseline Characteristics
Demographic data was unavailable for one participant.
Baseline characteristics by cohort
| Measure |
Participants Who Received Humira®
n=462 Participants
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 17.2 • n=461 Participants • Demographic data was unavailable for one participant.
|
|
Sex: Female, Male
Female
|
225 Participants
n=461 Participants • Demographic data was unavailable for one participant.
|
|
Sex: Female, Male
Male
|
236 Participants
n=461 Participants • Demographic data was unavailable for one participant.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=462 Participants
|
|
Race (NIH/OMB)
Asian
|
461 Participants
n=462 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=462 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=462 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=462 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=462 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=462 Participants
|
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety analysis set: All participants who received at least one administration of Humira® during the study (after informed consent or first administration of Humira®) and for 70 days following the last scheduled administration of Humira®.
The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.
Outcome measures
| Measure |
Participants Who Received Humira®
n=462 Participants
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Number of Participants With Adverse Drug Reactions
Infections and infestations
|
47 Participants
|
|
Number of Participants With Adverse Drug Reactions
Neoplasms benign, malignant and unspecified
|
5 Participants
|
|
Number of Participants With Adverse Drug Reactions
Blood and lymphatic system disorders
|
6 Participants
|
|
Number of Participants With Adverse Drug Reactions
Immune system disorders
|
1 Participants
|
|
Number of Participants With Adverse Drug Reactions
Endocrine disorders
|
3 Participants
|
|
Number of Participants With Adverse Drug Reactions
Metabolism and nutrition disorders
|
1 Participants
|
|
Number of Participants With Adverse Drug Reactions
Psychiatric disorders
|
3 Participants
|
|
Number of Participants With Adverse Drug Reactions
Nervous system disorders
|
7 Participants
|
|
Number of Participants With Adverse Drug Reactions
Eye disorders
|
1 Participants
|
|
Number of Participants With Adverse Drug Reactions
Vascular disorders
|
5 Participants
|
|
Number of Participants With Adverse Drug Reactions
Respiratory, thoracic and mediastinal disorders
|
9 Participants
|
|
Number of Participants With Adverse Drug Reactions
Gastrointestinal Disorders
|
20 Participants
|
|
Number of Participants With Adverse Drug Reactions
Hepatobiliary disorders
|
4 Participants
|
|
Number of Participants With Adverse Drug Reactions
Skin and subcutaneous tissue disorder
|
6 Participants
|
|
Number of Participants With Adverse Drug Reactions
Musculoskeletal and connective tissue disorder
|
9 Participants
|
|
Number of Participants With Adverse Drug Reactions
Pregnancy, puerperium and perinatal conditions
|
1 Participants
|
|
Number of Participants With Adverse Drug Reactions
General disorders and adminstration site condition
|
19 Participants
|
|
Number of Participants With Adverse Drug Reactions
Investigations
|
22 Participants
|
|
Number of Participants With Adverse Drug Reactions
Injury, poisoning and procedural complications
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 156Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
Study participants completed a global assessment of their gastrointestinal symptoms on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life.
Outcome measures
| Measure |
Participants Who Received Humira®
n=383 Participants
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Global Assessment of Gastrointestinal Symptoms
Baseline · Global assessment score = 0
|
52 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Baseline · Global assessment score = 1
|
55 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Baseline · Global assessment score = 2
|
76 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Baseline · Global assessment score = 3
|
88 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Baseline · Global assessment score = 4
|
98 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 4 · Global assessment score = 0
|
153 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 4 · Global assessment score = 1
|
85 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 4 · Global assessment score = 3
|
33 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 4 · Global assessment score = 4
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 8 · Global assessment score = 0
|
176 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 8 · Global assessment score = 1
|
72 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 8 · Global assessment score = 2
|
38 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 8 · Global assessment score = 3
|
19 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 8 · Global assessment score = 4
|
10 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 12 · Global assessment score = 0
|
169 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 12 · Global assessment score = 1
|
72 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 12 · Global assessment score = 2
|
32 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 12 · Global assessment score = 3
|
12 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 12 · Global assessment score = 4
|
7 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 24 · Global assessment score = 0
|
152 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 24 · Global assessment score = 1
|
44 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 24 · Global assessment score = 2
|
34 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 24 · Global assessment score = 3
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 24 · Global assessment score = 4
|
2 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 52 · Global assessment score = 0
|
142 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 52 · Global assessment score = 1
|
45 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 52 · Global assessment score = 2
|
22 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 52 · Global assessment score = 3
|
10 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 52 · Global assessment score = 4
|
2 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 76 · Global assessment score = 0
|
112 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 76 · Global assessment score = 1
|
38 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 76 · Global assessment score = 2
|
18 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 76 · Global assessment score = 3
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 76 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 104 · Global assessment score = 0
|
113 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 104 · Global assessment score = 1
|
39 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 104 · Global assessment score = 2
|
17 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 104 · Global assessment score = 3
|
3 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 104 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 128 · Global assessment score = 0
|
29 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 128 · Global assessment score = 1
|
12 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 128 · Global assessment score = 2
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 128 · Global assessment score = 3
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 128 · Global assessment score = 4
|
1 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 156 · Global assessment score = 0
|
32 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 156 · Global assessment score = 1
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 156 · Global assessment score = 2
|
9 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 156 · Global assessment score = 3
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 156 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms
Week 4 · Global assessment score = 2
|
44 Participants
|
SECONDARY outcome
Timeframe: Up to Week 156Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
Study participants completed a global assessment of their gastrointestinal symptoms (including abdominal pain, diarrhea and other gastrointestinal symptoms such as abdominal distension, abdominal tenderness, and hemorrhage) on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life.
Outcome measures
| Measure |
Participants Who Received Humira®
n=368 Participants
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 0 (baseline) · Global assessment score = 0
|
89 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 0 (baseline) · Global assessment score = 1
|
56 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 0 (baseline) · Global assessment score = 2
|
74 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 0 (baseline) · Global assessment score = 3
|
82 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 0 (baseline) · Global assessment score = 4
|
67 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 4 · Global assessment score = 0
|
181 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 4 · Global assessment score = 1
|
69 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 4 · Global assessment score = 2
|
39 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 4 · Global assessment score = 3
|
27 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 8 · Global assessment score = 0
|
202 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 8 · Global assessment score = 1
|
59 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 8 · Global assessment score = 2
|
28 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 8 · Global assessment score = 3
|
20 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 8 · Global assessment score = 4
|
5 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 12 · Global assessment score = 0
|
193 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 12 · Global assessment score = 1
|
54 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 12 · Global assessment score = 2
|
26 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 12 · Global assessment score = 3
|
13 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 12 · Global assessment score = 4
|
6 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 24 · Global assessment score = 0
|
174 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 24 · Global assessment score = 1
|
28 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 24 · Global assessment score = 2
|
29 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 24 · Global assessment score = 3
|
6 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 24 · Global assessment score = 4
|
2 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 52 · Global assessment score = 0
|
158 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 52 · Global assessment score = 1
|
31 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 52 · Global assessment score = 2
|
21 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 52 · Global assessment score = 3
|
10 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 76 · Global assessment score = 0
|
129 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 76 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 104 · Global assessment score = 0
|
132 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 104 · Global assessment score = 1
|
31 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 104 · Global assessment score = 2
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 104 · Global assessment score = 3
|
2 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 104 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 128 · Global assessment score = 0
|
36 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 128 · Global assessment score = 1
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 128 · Global assessment score = 2
|
4 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 128 · Global assessment score = 3
|
1 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 128 · Global assessment score = 4
|
1 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 156 · Global assessment score = 0
|
36 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 4 · Global assessment score = 0
|
226 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 4 · Global assessment score = 1
|
52 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 4 · Global assessment score = 2
|
27 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 4 · Global assessment score = 4
|
3 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 8 · Global assessment score = 0
|
232 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 8 · Global assessment score = 1
|
54 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 8 · Global assessment score = 3
|
7 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 12 · Global assessment score = 3
|
5 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 52 · Global assessment score = 0
|
176 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 52 · Global assessment score = 1
|
28 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 52 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 76 · Global assessment score = 0
|
131 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 76 · Global assessment score = 1
|
31 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 104 · Global assessment score = 1
|
26 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 104 · Global assessment score = 2
|
10 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 128 · Global assessment score = 0
|
36 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 128 · Global assessment score = 2
|
3 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 128 · Global assessment score = 3
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 128 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 156 · Global assessment score = 0
|
37 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 156 · Global assessment score = 1
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 156 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 0/baseline · Global assessment score = 0
|
124 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 0/baseline · Global assessment score = 1
|
54 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 0/baseline · Global assessment score = 2
|
61 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 0/baseline · Global assessment score = 3
|
68 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 4 · Global assessment score = 3
|
16 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 8 · Global assessment score = 1
|
44 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 8 · Global assessment score = 3
|
10 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 8 · Global assessment score = 4
|
7 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 12 · Global assessment score = 0
|
220 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 12 · Global assessment score = 1
|
40 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 12 · Global assessment score = 2
|
21 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 24 · Global assessment score = 0
|
188 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 24 · Global assessment score = 1
|
28 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 24 · Global assessment score = 2
|
19 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 24 · Global assessment score = 3
|
2 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 52 · Global assessment score = 0
|
172 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 52 · Global assessment score = 1
|
26 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 52 · Global assessment score = 3
|
6 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 76 · Global assessment score = 1
|
20 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 76 · Global assessment score = 2
|
13 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 76 · Global assessment score = 3
|
5 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 76 · Global assessment score = 4
|
1 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 104 · Global assessment score = 0
|
143 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 104 · Global assessment score = 1
|
17 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 104 · Global assessment score = 2
|
10 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 104 · Global assessment score = 3
|
3 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 104 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 128 · Global assessment score = 0
|
36 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 128 · Global assessment score = 1
|
11 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 128 · Global assessment score = 2
|
1 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 128 · Global assessment score = 3
|
1 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 128 · Global assessment score = 4
|
1 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 156 · Global assessment score = 0
|
37 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 156 · Global assessment score = 1
|
7 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 156 · Global assessment score = 2
|
4 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 156 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 12 · Global assessment score = 3
|
7 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 12 · Global assessment score = 4
|
4 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 24 · Global assessment score = 4
|
2 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 52 · Global assessment score = 2
|
15 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 52 · Global assessment score = 4
|
1 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 76 · Global assessment score = 0
|
138 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 156 · Global assessment score = 3
|
1 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 4 · Global assessment score = 4
|
6 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 52 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 76 · Global assessment score = 1
|
26 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 76 · Global assessment score = 2
|
14 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 76 · Global assessment score = 3
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 156 · Global assessment score = 1
|
5 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 156 · Global assessment score = 2
|
8 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 156 · Global assessment score = 3
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Abdominal pain at week 156 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 0 (baseline) · Global assessment score = 0
|
167 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 0 (baseline) · Global assessment score = 1
|
61 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 0 (baseline) · Global assessment score = 2
|
54 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 0 (baseline) · Global assessment score = 3
|
50 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 0 (baseline) · Global assessment score = 4
|
36 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 4 · Global assessment score = 3
|
14 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 8 · Global assessment score = 2
|
18 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 8 · Global assessment score = 4
|
3 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 12 · Global assessment score = 0
|
221 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 12 · Global assessment score = 1
|
37 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 12 · Global assessment score = 2
|
26 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 12 · Global assessment score = 4
|
3 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 24 · Global assessment score = 0
|
181 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 24 · Global assessment score = 1
|
35 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 24 · Global assessment score = 2
|
21 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 24 · Global assessment score = 3
|
2 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 24 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 52 · Global assessment score = 2
|
12 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 52 · Global assessment score = 3
|
4 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 76 · Global assessment score = 2
|
10 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 76 · Global assessment score = 3
|
5 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 76 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 104 · Global assessment score = 0
|
135 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 104 · Global assessment score = 3
|
2 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 104 · Global assessment score = 4
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 128 · Global assessment score = 1
|
11 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 156 · Global assessment score = 2
|
4 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Diarrhoea at week 156 · Global assessment score = 3
|
0 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 0/baseline · Global assessment score = 4
|
61 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 4 · Global assessment score = 0
|
219 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 4 · Global assessment score = 1
|
49 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 4 · Global assessment score = 2
|
31 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 4 · Global assessment score = 4
|
7 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 8 · Global assessment score = 0
|
226 Participants
|
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Other gastrointestinal symptoms at week 8 · Global assessment score = 2
|
27 Participants
|
SECONDARY outcome
Timeframe: Up to Week 156Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
The presence or absence of symptoms including recurrent aphthous ulcers of oral mucosa, cutaneous symptoms, eye symptoms and ulceration of vulva was assessed at weeks 52, 104 and 156 against presence or absence at baseline.
Outcome measures
| Measure |
Participants Who Received Humira®
n=220 Participants
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcer of oral mucosa at week104 · Assessment absence and baseline absence
|
74 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcer of oral mucosa at week104 · Assessment presence and baseline presence
|
26 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcer of oral mucosa at week156 · Assessment absence and baseline absence
|
27 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcer of oral mucosa at week156 · Assessment absence and baseline presence
|
12 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcer of oral mucosa at week156 · Assessment presence and baseline absence
|
5 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcer of oral mucosa at week156 · Assessment presence and baseline presence
|
5 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 52 · Assessment absence and baseline absence
|
147 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 52 · Assessment absence and baseline presence
|
56 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 52 · Assessment presence and baseline absence
|
5 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 52 · Assessment presence and baseline presence
|
11 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 156 · Assessment absence and baseline presence
|
13 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 156 · Assessment presence and baseline absence
|
4 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 156 · Assessment presence and baseline presence
|
0 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 52 · Assessment absence and baseline absence
|
216 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 52 · Assessment presence and baseline absence
|
0 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 52 · Assessment presence and baseline presence
|
1 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 104 · Assessment absence and baseline absence
|
168 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 104 · Assessment absence and baseline presence
|
4 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 104 · Assessment presence and baseline absence
|
1 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 104 · Assessment presence and baseline presence
|
0 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 156 · Assessment absence and baseline absence
|
48 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 156 · Assessment absence and baseline presence
|
1 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 156 · Assessment presence and baseline absence
|
0 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 156 · Assessment presence and baseline presence
|
0 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 52 · Assessment absence and baseline absence
|
184 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 52 · Assessment absence and baseline presence
|
27 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 52 · Assessment presence and baseline absence
|
1 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcers of oral mucosa at week52 · Assessment absence and baseline absence
|
99 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcers of oral mucosa at week52 · Assessment absence and baseline presence
|
84 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcers of oral mucosa at week52 · Assessment presence and baseline absence
|
7 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcers of oral mucosa at week52 · Assessment presence and baseline presence
|
29 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcer of oral mucosa at week104 · Assessment absence and baseline presence
|
59 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Recurrent aphthous ulcer of oral mucosa at week104 · Assessment presence and baseline absence
|
13 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 104 · Assessment absence and baseline absence
|
123 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 104 · Assessment absence and baseline presence
|
34 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 104 · Assessment presence and baseline absence
|
7 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 104 · Assessment presence and baseline presence
|
9 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Cutaneous symptoms at week 156 · Assessment absence and baseline absence
|
32 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Eye symptoms at week 52 · Assessment absence and baseline presence
|
3 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 52 · Assessment presence and baseline presence
|
8 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 104 · Assessment absence and baseline absence
|
151 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 104 · Assessment absence and baseline presence
|
14 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 104 · Assessment presence and baseline absence
|
4 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 104 · Assessment presence and baseline presence
|
4 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 156 · Assessment absence and baseline absence
|
42 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 156 · Assessment absence and baseline presence
|
5 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 156 · Assessment presence and baseline absence
|
1 Participants
|
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Ulceration of vulva at week 156 · Assessment presence and baseline presence
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 156Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
The presence or absence of symptoms including arthritis without deformity or stiffness, epididymitis, vascular lesions and moderate to severe central nervous system (CNS) lesions was assessed at weeks 52, 104 and 156 against presence or absence at baseline.
Outcome measures
| Measure |
Participants Who Received Humira®
n=221 Participants
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 52 · Assessment absence and baseline absence
|
150 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 52 · Assessment absence and baseline presence
|
39 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 52 · Assessment presence and baseline absence
|
11 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 52 · Assessment presence and baseline presence
|
21 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 104 · Assessment absence and baseline absence
|
115 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 156 · Assessment absence and baseline absence
|
46 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 156 · Assessment absence and baseline presence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 156 · Assessment presence and baseline absence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 156 · Assessment presence and baseline presence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 52 · Assessment absence and baseline presence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 52 · Assessment presence and baseline absence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 52 · Assessment presence and baseline presence
|
2 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 104 · Assessment absence and baseline absence
|
171 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 104 · Assessment absence and baseline presence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 104 · Assessment presence and baseline absence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 104 · Assessment presence and baseline presence
|
2 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 156 · Assessment absence and baseline absence
|
48 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 156 · Assessment absence and baseline presence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 156 · Assessment presence and baseline absence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 156 · Assessment presence and baseline presence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 104 · Assessment absence and baseline presence
|
36 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 104 · Assessment presence and baseline absence
|
14 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 104 · Assessment presence and baseline presence
|
9 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 156 · Assessment absence and baseline absence
|
30 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 156 · Assessment absence and baseline presence
|
14 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 156 · Assessment presence and baseline absence
|
5 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Arthritis without deformity/ stiffness at week 156 · Assessment presence and baseline presence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 52 · Assessment absence and baseline absence
|
219 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 52 · Assessment absence and baseline presence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 52 · Assessment presence and baseline absence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 52 · Assessment presence and baseline presence
|
2 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 104 · Assessment absence and baseline absence
|
172 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 104 · Assessment absence and baseline presence
|
2 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 104 · Assessment presence and baseline absence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Epididymitis at week 104 · Assessment presence and baseline presence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 52 · Assessment absence and baseline absence
|
213 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 52 · Assessment absence and baseline presence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 52 · Assessment presence and baseline absence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 52 · Assessment presence and baseline presence
|
7 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 104 · Assessment absence and baseline absence
|
168 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 104 · Assessment absence and baseline presence
|
4 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 104 · Assessment presence and baseline absence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 104 · Assessment presence and baseline presence
|
2 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 156 · Assessment absence and baseline absence
|
47 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 156 · Assessment absence and baseline presence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 156 · Assessment presence and baseline absence
|
1 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Vascular lesions at week 156 · Assessment presence and baseline presence
|
0 Participants
|
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Moderate to severe CNS lesions at week 52 · Assessment absence and baseline absence
|
217 Participants
|
SECONDARY outcome
Timeframe: Up to Week 156Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
The number of participants with improvement in endoscopic findings is assessed.
Outcome measures
| Measure |
Participants Who Received Humira®
n=383 Participants
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Baseline to < Week 24 · Cured or scarring
|
64 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Baseline to < Week 24 · Diminished in size
|
38 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Baseline to < Week 24 · Unchanged
|
24 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Baseline to < Week 24 · Aggravated
|
9 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Baseline to < Week 24 · Unassessable
|
2 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 24 to < Week 52 · Cured or scarring
|
73 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 24 to < Week 52 · Diminished in size
|
29 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 24 to < Week 52 · Unchanged
|
12 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 24 to < Week 52 · Aggravated
|
6 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 24 to < Week 52 · Unassessable
|
8 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 52 to < Week 76 · Cured or scarring
|
42 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 76 to < Week 104 · Cured or scarring
|
29 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 76 to < Week 104 · Diminished in size
|
6 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 76 to < Week 104 · Unchanged
|
7 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 76 to < Week 104 · Aggravated
|
5 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 76 to < Week 104 · Unassessable
|
2 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 104 to < Week 128 · Cured or scarring
|
16 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 52 to < Week 76 · Diminished in size
|
6 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 52 to < Week 76 · Unchanged
|
9 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 52 to < Week 76 · Aggravated
|
0 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 52 to < Week 76 · Unassessable
|
3 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 104 to < Week 128 · Diminished in size
|
3 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 104 to < Week 128 · Unchanged
|
1 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 104 to < Week 128 · Aggravated
|
1 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 104 to < Week 128 · Unassessable
|
1 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 128 to < Week 160 · Cured or scarring
|
9 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 128 to < Week 160 · Diminished in size
|
1 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 128 to < Week 160 · Unchanged
|
0 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 128 to < Week 160 · Aggravated
|
0 Participants
|
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Week 128 to < Week 160 · Unassessable
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 156Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
The change in CRP from baseline through the end of the study was assessed.
Outcome measures
| Measure |
Participants Who Received Humira®
n=383 Participants
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Changes in C-reactive Protein (CRP)
Baseline
|
2.0239 mg/dL
Standard Deviation 3.4242
|
|
Changes in C-reactive Protein (CRP)
Week 24
|
0.5389 mg/dL
Standard Deviation 1.5150
|
|
Changes in C-reactive Protein (CRP)
Week 52
|
0.5504 mg/dL
Standard Deviation 1.4651
|
|
Changes in C-reactive Protein (CRP)
Week 76
|
0.3348 mg/dL
Standard Deviation 0.8126
|
|
Changes in C-reactive Protein (CRP)
Week 104
|
0.4031 mg/dL
Standard Deviation 1.1279
|
|
Changes in C-reactive Protein (CRP)
Week 128
|
0.5034 mg/dL
Standard Deviation 2.5356
|
|
Changes in C-reactive Protein (CRP)
Week 156
|
0.2246 mg/dL
Standard Deviation 0.5808
|
Adverse Events
Participants Who Received Humira®
Serious events: 75 serious events
Other events: 165 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Participants Who Received Humira®
n=462 participants at risk
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Infections and infestations
BRONCHITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
MENINGITIS LISTERIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PERIODONTITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PHARYNGITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PNEUMONIA
|
1.1%
5/462 • Number of events 5 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PSEUDOMEMBRANOUS COLITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
SEPSIS
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
ANAL ABSCESS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
COLONIC ABSCESS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
VARICELLA ZOSTER VIRUS INFECTION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC MYELOMONOCYTIC LEUKAEMIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL STROMAL TUMOUR
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME TRANSFORMATION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
ANAEMIA MEGALOBLASTIC
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
BONE MARROW FAILURE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Endocrine disorders
ADRENAL DISORDER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Endocrine disorders
DIABETES INSIPIDUS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Endocrine disorders
THYROIDITIS SUBACUTE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Vascular disorders
BEHCET'S SYNDROME
|
2.4%
11/462 • Number of events 11 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ILEAL PERFORATION
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ILEAL ULCER
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ILEUS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
STOMATITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
FISTULA OF SMALL INTESTINE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
DENTAL CYST
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
LUPUS-LIKE SYNDROME
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION MISSED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
General disorders
PYREXIA
|
1.5%
7/462 • Number of events 7 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
PLATELET COUNT DECREASED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
Other adverse events
| Measure |
Participants Who Received Humira®
n=462 participants at risk
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration
|
|---|---|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
VARICELLA ZOSTER VIRUS INFECTION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
ANGULAR CHEILITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
BRONCHITIS
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
CELLULITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
CYSTITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
GASTROENTERITIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
HERPES ZOSTER
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
INFLUENZA
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
MENINGITIS LISTERIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.2%
10/462 • Number of events 10 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
OTITIS MEDIA
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
OTITIS MEDIA CHRONIC
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PERIODONTITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PHARYNGITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PNEUMONIA
|
1.5%
7/462 • Number of events 7 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PSEUDOMEMBRANOUS COLITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PYELONEPHRITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
SEPSIS
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
SINUSITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
TINEA PEDIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
TONSILLITIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
ANAL ABSCESS
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
ENTERITIS INFECTIOUS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
LUNG INFECTION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
ENTEROCOLITIS VIRAL
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
LATENT TUBERCULOSIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
ORAL HERPES
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Infections and infestations
COLONIC ABSCESS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC MYELOMONOCYTIC LEUKAEMIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON ADENOMA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL STROMAL TUMOUR
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME TRANSFORMATION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
ANAEMIA MEGALOBLASTIC
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Blood and lymphatic system disorders
BONE MARROW FAILURE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Immune system disorders
HYPOGAMMAGLOBULINAEMIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Endocrine disorders
ADRENAL DISORDER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Endocrine disorders
DIABETES INSIPIDUS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Endocrine disorders
THYROIDITIS SUBACUTE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Metabolism and nutrition disorders
HYPERAMYLASAEMIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Metabolism and nutrition disorders
HYPERLIPASAEMIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Psychiatric disorders
INSOMNIA
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Psychiatric disorders
OBSESSIVE-COMPULSIVE DISORDER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Psychiatric disorders
DEPRESSIVE SYMPTOM
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
DYSGEUSIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
DYSLALIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
HEADACHE
|
0.87%
4/462 • Number of events 4 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
PRESYNCOPE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Nervous system disorders
TREMOR
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Eye disorders
CONJUNCTIVITIS ALLERGIC
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Eye disorders
VITREOUS FLOATERS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Vascular disorders
BEHCET'S SYNDROME
|
3.2%
15/462 • Number of events 15 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Vascular disorders
HYPOTENSION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL ULCERATION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFLAMMATION
|
0.87%
4/462 • Number of events 4 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
COLITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
GASTRITIS ALCOHOLIC
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ILEAL PERFORATION
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ILEAL ULCER
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
ILEUS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
INTESTINAL STENOSIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
INTESTINAL ULCER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
NAUSEA
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
STOMATITIS
|
1.1%
5/462 • Number of events 5 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
VOMITING
|
0.65%
3/462 • Number of events 3 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
FISTULA OF SMALL INTESTINE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
FAECES SOFT
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Gastrointestinal disorders
DENTAL CYST
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
ALCOHOLIC LIVER DISEASE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION MISSED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
General disorders
ASTHENIA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
General disorders
INJECTION SITE REACTION
|
0.87%
4/462 • Number of events 4 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
General disorders
MALAISE
|
1.1%
5/462 • Number of events 5 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
General disorders
PAIN
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
General disorders
PYREXIA
|
2.8%
13/462 • Number of events 13 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
2.6%
12/462 • Number of events 12 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
PLATELET COUNT DECREASED
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
1.1%
5/462 • Number of events 5 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
ANTITHROMBIN III DECREASED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
BLOOD BETA-D-GLUCAN INCREASED
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
BRAIN NATRIURETIC PEPTIDE INCREASED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
TRANSAMINASES INCREASED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
COMPUTERISED TOMOGRAM THORAX ABNORMAL
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.3%
6/462 • Number of events 6 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Musculoskeletal and connective tissue disorders
LUPUS-LIKE SYNDROME
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Skin and subcutaneous tissue disorders
DYSHIDROTIC ECZEMA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Skin and subcutaneous tissue disorders
HAEMORRHAGE SUBCUTANEOUS
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Skin and subcutaneous tissue disorders
PRURIGO
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.43%
2/462 • Number of events 2 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Skin and subcutaneous tissue disorders
GENERALISED ERYTHEMA
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
|
Skin and subcutaneous tissue disorders
DERMATITIS PSORIASIFORM
|
0.22%
1/462 • Number of events 1 • Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER