Trial Outcomes & Findings for Special Investigation (Long-term Investigation) in Patients With Crohn's Disease (NCT NCT01464333)
NCT ID: NCT01464333
Last Updated: 2019-05-20
Results Overview
An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details.
Recruitment status
COMPLETED
Target enrollment
511 participants
Primary outcome timeframe
From first dose of Humira up to 3 years
Results posted on
2019-05-20
Participant Flow
Of the 511 patients enrolled, case report forms were not collected from 7 patients (N = 504). The safety analysis set excluded 115 enrolled patients due to "safety assessment impossible" (N = 389). The efficacy analysis set excluded 79 patients that were included in the safety analysis set due to "efficacy assessment impossible" (N = 310).
Participant milestones
| Measure |
Humira
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Overall Study
STARTED
|
389
|
|
Overall Study
COMPLETED
|
226
|
|
Overall Study
NOT COMPLETED
|
163
|
Reasons for withdrawal
| Measure |
Humira
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Overall Study
Adverse Event
|
34
|
|
Overall Study
Lack of Efficacy
|
72
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Other
|
4
|
|
Overall Study
No Hospital Visit
|
42
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Humira
n=389 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 11.8 • n=389 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=389 Participants
|
|
Sex: Female, Male
Male
|
283 Participants
n=389 Participants
|
|
Region of Enrollment
Japan
|
389 participants
n=389 Participants
|
PRIMARY outcome
Timeframe: From first dose of Humira up to 3 yearsPopulation: Safety Analysis Set
An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details.
Outcome measures
| Measure |
Humira
n=389 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Number of Participants With Adverse Events
Serious Adverse Events
|
58 participants
|
|
Number of Participants With Adverse Events
Non-serious Adverse Events
|
104 participants
|
SECONDARY outcome
Timeframe: From first dose of Humira up to 3 yearsPopulation: Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment
The Change in Crohn's Disease Activity Index (CDAI) is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Humira
n=310 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
At first administration
|
193.68 units on a scale
Standard Deviation 103.00
|
|
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
Week 4 of administration
|
115.17 units on a scale
Standard Deviation 72.21
|
|
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
Month 3 of administration
|
108.43 units on a scale
Standard Deviation 80.45
|
|
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
Month 6 of administration
|
100.29 units on a scale
Standard Deviation 84.14
|
|
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
Year 1 of administration
|
108.81 units on a scale
Standard Deviation 83.40
|
|
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
Year 1 and Month 6 of administration
|
90.86 units on a scale
Standard Deviation 71.84
|
|
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
Year 2 of administration
|
93.90 units on a scale
Standard Deviation 75.99
|
|
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
Year 2 and Month 6 of administration
|
88.92 units on a scale
Standard Deviation 76.62
|
|
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
Year 3 of administration
|
94.89 units on a scale
Standard Deviation 81.61
|
SECONDARY outcome
Timeframe: From first dose of Humira up to 3 yearsPopulation: Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to CD) is calculated as the number of hours of work missed due to CD / (number of hours of work missed due to CD + number of hours worked) \* 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Humira
n=310 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
At first administration
|
30.71 percentage of work time missed
Standard Deviation 42.35
|
|
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
Week 4 of administration
|
11.86 percentage of work time missed
Standard Deviation 28.81
|
|
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
Month 3 of administration
|
11.12 percentage of work time missed
Standard Deviation 28.17
|
|
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
Month 6 of administration
|
7.04 percentage of work time missed
Standard Deviation 22.35
|
|
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
Year 1 of administration
|
8.34 percentage of work time missed
Standard Deviation 24.94
|
|
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
Year 1 and Month 6 of administration
|
10.34 percentage of work time missed
Standard Deviation 28.03
|
|
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
Year 2 of administration
|
5.49 percentage of work time missed
Standard Deviation 19.54
|
|
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
Year 2 and Month 6 of administration
|
7.33 percentage of work time missed
Standard Deviation 23.26
|
|
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
Year 3 of administration
|
4.69 percentage of work time missed
Standard Deviation 21.30
|
SECONDARY outcome
Timeframe: From first dose of Humira up to 3 yearsPopulation: Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to CD ) is calculated as the patient's rating of how much CD affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 \* 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Humira
n=310 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Change in WPAI: CD Presenteeism Over Time
At first administration
|
38.13 Percent impairment while working
Standard Deviation 32.87
|
|
Change in WPAI: CD Presenteeism Over Time
Week 4 of administration
|
24.57 Percent impairment while working
Standard Deviation 27.07
|
|
Change in WPAI: CD Presenteeism Over Time
Month 3 of administration
|
24.03 Percent impairment while working
Standard Deviation 26.91
|
|
Change in WPAI: CD Presenteeism Over Time
Month 6 of administration
|
19.85 Percent impairment while working
Standard Deviation 27.47
|
|
Change in WPAI: CD Presenteeism Over Time
Year 1 of administration
|
22.22 Percent impairment while working
Standard Deviation 28.93
|
|
Change in WPAI: CD Presenteeism Over Time
Year 1 and Month 6 of administration
|
27.69 Percent impairment while working
Standard Deviation 32.80
|
|
Change in WPAI: CD Presenteeism Over Time
Year 2 of administration
|
21.85 Percent impairment while working
Standard Deviation 24.18
|
|
Change in WPAI: CD Presenteeism Over Time
Year 2 and Month 6 of administration
|
20.40 Percent impairment while working
Standard Deviation 29.08
|
|
Change in WPAI: CD Presenteeism Over Time
Year 3 of administration
|
14.21 Percent impairment while working
Standard Deviation 24.11
|
SECONDARY outcome
Timeframe: From first dose of Humira up to 3 yearsPopulation: Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment \[OWI\]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Humira
n=310 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Change in WPAI: CD Overall Work Impairment Over Time
At first administration
|
42.68 Percent overall work impairment
Standard Deviation 34.71
|
|
Change in WPAI: CD Overall Work Impairment Over Time
Week 4 of administration
|
26.89 Percent overall work impairment
Standard Deviation 28.45
|
|
Change in WPAI: CD Overall Work Impairment Over Time
Month 3 of administration
|
25.85 Percent overall work impairment
Standard Deviation 30.40
|
|
Change in WPAI: CD Overall Work Impairment Over Time
Month 6 of administration
|
20.17 Percent overall work impairment
Standard Deviation 28.63
|
|
Change in WPAI: CD Overall Work Impairment Over Time
Year 1 of administration
|
23.89 Percent overall work impairment
Standard Deviation 30.43
|
|
Change in WPAI: CD Overall Work Impairment Over Time
Year 1 and Month 6 of administration
|
27.64 Percent overall work impairment
Standard Deviation 33.18
|
|
Change in WPAI: CD Overall Work Impairment Over Time
Year 2 of administration
|
22.83 Percent overall work impairment
Standard Deviation 26.22
|
|
Change in WPAI: CD Overall Work Impairment Over Time
Year 2 and Month 6 of administration
|
19.77 Percent overall work impairment
Standard Deviation 29.93
|
|
Change in WPAI: CD Overall Work Impairment Over Time
Year 3 of administration
|
14.27 Percent overall work impairment
Standard Deviation 25.06
|
SECONDARY outcome
Timeframe: From first dose of Humira up to 3 yearsPopulation: Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to CD ) is calculated as the patient's rating of how much CD affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 \* 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Humira
n=310 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Change in WPAI: CD Activity Impairment Over Time
At first administration
|
50.22 Percent activity impairment
Standard Deviation 31.45
|
|
Change in WPAI: CD Activity Impairment Over Time
Week 4 of administration
|
29.22 Percent activity impairment
Standard Deviation 26.64
|
|
Change in WPAI: CD Activity Impairment Over Time
Month 3 of administration
|
26.46 Percent activity impairment
Standard Deviation 26.82
|
|
Change in WPAI: CD Activity Impairment Over Time
Month 6 of administration
|
23.66 Percent activity impairment
Standard Deviation 25.22
|
|
Change in WPAI: CD Activity Impairment Over Time
Year 1 of administration
|
21.76 Percent activity impairment
Standard Deviation 24.36
|
|
Change in WPAI: CD Activity Impairment Over Time
Year 1 and Month 6 of administration
|
26.51 Percent activity impairment
Standard Deviation 25.98
|
|
Change in WPAI: CD Activity Impairment Over Time
Year 2 of administration
|
21.52 Percent activity impairment
Standard Deviation 21.91
|
|
Change in WPAI: CD Activity Impairment Over Time
Year 2 and Month 6 of administration
|
24.88 Percent activity impairment
Standard Deviation 25.01
|
|
Change in WPAI: CD Activity Impairment Over Time
Year 3 of administration
|
14.62 Percent activity impairment
Standard Deviation 18.60
|
SECONDARY outcome
Timeframe: From first dose of Humira up to 3 yearsPopulation: Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment
Endoscopic remission per endoscopy sub score.
Outcome measures
| Measure |
Humira
n=310 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Large intsetine: Year 2 of administration
|
35 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Large intestine: start of administration
|
20 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Large intestine: Month 6 of administration
|
17 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Large intestine: Year 1 of administration
|
31 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Large intestine: Year 3 of administration
|
36 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Small intestine: at first administration
|
7 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Small intestine: Month 6 of administration
|
15 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Small intestine: Year 1 of administration
|
25 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Small intestine: Year 2 of administration
|
16 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Small intestine: Year 3 of administration
|
19 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Both intestine: start of administration
|
2 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Both intestine: Mont 6 of administration
|
5 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Both intestine: Year 1 of administration
|
16 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Both intestine: Year 2 of administration
|
8 Participants
|
|
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Both intestine: Year 3 of administration
|
11 Participants
|
SECONDARY outcome
Timeframe: From first dose of Humira up to 3 yearsPopulation: Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment
CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.
Outcome measures
| Measure |
Humira
n=310 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Change in C-Reactive Protein (CRP) Levels Over Time
Week 4 of administration
|
0.43 mg/dL
Standard Deviation 0.99
|
|
Change in C-Reactive Protein (CRP) Levels Over Time
Month 3 of administration
|
0.55 mg/dL
Standard Deviation 1.09
|
|
Change in C-Reactive Protein (CRP) Levels Over Time
Month 6 of administration
|
0.53 mg/dL
Standard Deviation 1.18
|
|
Change in C-Reactive Protein (CRP) Levels Over Time
Year 1 of administration
|
0.54 mg/dL
Standard Deviation 1.00
|
|
Change in C-Reactive Protein (CRP) Levels Over Time
Year 1 and Month 6 of administration
|
0.49 mg/dL
Standard Deviation 1.31
|
|
Change in C-Reactive Protein (CRP) Levels Over Time
Year 2 of administration
|
0.44 mg/dL
Standard Deviation 1.03
|
|
Change in C-Reactive Protein (CRP) Levels Over Time
Year 2 and Month 6 of administration
|
0.52 mg/dL
Standard Deviation 1.38
|
|
Change in C-Reactive Protein (CRP) Levels Over Time
Year 3 of administration
|
0.66 mg/dL
Standard Deviation 2.90
|
|
Change in C-Reactive Protein (CRP) Levels Over Time
At first administration
|
1.53 mg/dL
Standard Deviation 2.00
|
Adverse Events
Humira
Serious events: 58 serious events
Other events: 104 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Humira
n=389 participants at risk
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Infections and infestations
Endocarditis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Fungal infection
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Gastroenteritis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Gastroenteritis viral
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Herpes zoster
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Peritonitis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Pneumonia
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Postoperative wound infection
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Pyelonephritis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Sepsis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Anal abscess
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Abdominal abscess
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Device related sepsis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Immune system disorders
Eosinophilic granulomatosis with polyangiitis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
Tetany
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
Completed suicide
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Headache
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Crohn's disease
|
2.1%
8/389 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Ileal stenosis
|
1.0%
4/389 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Ileus
|
0.77%
3/389 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
1.0%
4/389 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.77%
3/389 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Subileus
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
1.0%
4/389 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Collagen disorder
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Pyrexia
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
C-reactive protein increased
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Platelet count decreased
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
| Measure |
Humira
n=389 participants at risk
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
4/389 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.77%
3/389 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Collagen disorder
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Bronchitis
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Cellulitis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Herpes zoster
|
0.77%
3/389 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Influenza
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
8/389 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Pneumonia
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Rhinitis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Sepsis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Tinea pedis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Tonsillitis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Tracheobronchitis mycoplasmal
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Urethritis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Viral infection
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Anal abscess
|
0.77%
3/389 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Psoas abscess
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Enteritis infectious
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.77%
3/389 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Anal fistula
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Crohn's disease
|
2.1%
8/389 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Gastritis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.77%
3/389 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Nausea
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Stomatitis
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Dyschezia
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
4/389 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.0%
4/389 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Immune system disorders
Seasonal allergy
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Immune system disorders
Eosinophilic granulomatosis with polyangiitis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
Insomnia
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
Adjustment disorder
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Dizziness
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Headache
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Hypoaesthesia
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Cardiac disorders
Palpitations
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
Aortitis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Cholestasis
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.77%
3/389 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Jaundice
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Face oedema
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Injection site erythema
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Injection site pruritus
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Injection site reaction
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Oedema peripheral
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Pyrexia
|
1.0%
4/389 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Injection site swelling
|
0.77%
3/389 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Blood cholesterol increased
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Blood creatinine increased
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
C-reactive protein increased
|
3.1%
12/389 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Chest X-ray abnormal
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Platelet count decreased
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
White blood cell count decreased
|
0.51%
2/389 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Blood beta-D-glucan increased
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Hepatic enzyme increased
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Pancreatic enzymes increased
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Antinuclear antibody increased
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Double stranded DNA antibody positive
|
0.26%
1/389 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.00%
0/389 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).
TEAEs were collected whether elicited or spontaneously reported by the participant.
|
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