Trial Outcomes & Findings for Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis (NCT NCT04128579)
NCT ID: NCT04128579
Last Updated: 2025-04-18
Results Overview
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Type A up to Day 57 or Type B up to Day 253
Results posted on
2025-04-18
Participant Flow
Participant milestones
| Measure |
EQ001 Type A Cohort (0.4mg/kg)
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 for Type B Cohort
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (0.8mg/kg)
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.8mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (1.6mg/kg)
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 1.6mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (2.4mg/kg)
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 2.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (3.2mg/kg)
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 3.2mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
17
|
7
|
7
|
6
|
9
|
|
Overall Study
COMPLETED
|
6
|
14
|
6
|
6
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
1
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Baseline characteristics by cohort
| Measure |
EQ001 Type A Cohort (0.4mg/kg)
n=6 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 for Type B Cohort
n=17 Participants
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (0.8mg/kg)
n=7 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.8mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (1.6mg/kg)
n=7 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 1.6mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (2.4mg/kg)
n=6 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 2.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (3.2mg/kg)
n=9 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 3.2mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 11.18 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 16.20 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 6.82 • n=4 Participants
|
48.2 years
STANDARD_DEVIATION 11.63 • n=21 Participants
|
55.0 years
STANDARD_DEVIATION 11.09 • n=8 Participants
|
45.3 years
STANDARD_DEVIATION 14.52 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
49 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
9 participants
n=8 Participants
|
40 participants
n=8 Participants
|
|
Region of Enrollment
India
|
0 participants
n=5 Participants
|
12 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
12 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Type A up to Day 57 or Type B up to Day 253Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Outcome measures
| Measure |
EQ001 Type A Cohort (0.4mg/kg)
n=6 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 for Type B Cohort
n=17 Participants
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (0.8mg/kg)
n=7 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.8mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (1.6mg/kg)
n=7 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 1.6mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (2.4mg/kg)
n=6 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 2.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (3.2mg/kg)
n=9 Participants
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 3.2mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events
|
0 Participants
|
17 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Type A up to Day 57 or Type B up to Day 253To characterize the pharmacokinetics of itolizumab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Type A up to Day 57 or Type B up to Day 253the % levels of free versus EQ001-bound CD6 receptor on T cells
Outcome measures
Outcome data not reported
Adverse Events
EQ001 Type A Cohort (0.4mg/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EQ001 for Type B Cohort
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
EQ001 Type A Cohort (0.8mg/kg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
EQ001 Type A Cohort (1.6mg/kg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
EQ001 Type A Cohort (2.4mg/kg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
EQ001 Type A Cohort (3.2mg/kg)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EQ001 Type A Cohort (0.4mg/kg)
n=6 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 for Type B Cohort
n=17 participants at risk
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (0.8mg/kg)
n=7 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.8mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (1.6mg/kg)
n=7 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 1.6mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (2.4mg/kg)
n=6 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 2.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (3.2mg/kg)
n=9 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 3.2mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Renal and urinary disorders
Renal Deterioration
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar hemorrhage
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Abscess on the proximal aspect of left thigh
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Right elbow septic arthritis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
Other adverse events
| Measure |
EQ001 Type A Cohort (0.4mg/kg)
n=6 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 for Type B Cohort
n=17 participants at risk
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (0.8mg/kg)
n=7 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.8mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (1.6mg/kg)
n=7 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 1.6mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (2.4mg/kg)
n=6 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 2.4mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
EQ001 Type A Cohort (3.2mg/kg)
n=9 participants at risk
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 3.2mg/kg.
Itolizumab \[Bmab 600\]: EQ001
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
14.3%
1/7 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
28.6%
2/7 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
33.3%
3/9 • Number of events 3 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
14.3%
1/7 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
33.3%
3/9 • Number of events 3 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Chills
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
33.3%
3/9 • Number of events 3 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Fatigue
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
16.7%
1/6 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.8%
2/17 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
22.2%
2/9 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
33.3%
2/6 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
44.4%
4/9 • Number of events 4 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
52.9%
9/17 • Number of events 9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
14.3%
1/7 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
33.3%
2/6 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.8%
2/17 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
16.7%
1/6 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
17.6%
3/17 • Number of events 3 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
17.6%
3/17 • Number of events 3 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
29.4%
5/17 • Number of events 5 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
23.5%
4/17 • Number of events 4 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.8%
2/17 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.8%
2/17 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
14.3%
1/7 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
17.6%
3/17 • Number of events 3 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
17.6%
3/17 • Number of events 3 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.8%
2/17 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.8%
2/17 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.8%
2/17 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.8%
2/17 • Number of events 2 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Generalised oedema
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Mucosal ulceration
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Oedema
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Pain
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Abcess limb
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
14.3%
1/7 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Rash erythematosus
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Vascular disorders
Palor
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Renal and urinary disorders
Renal impairement
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Investigations
Liver function test increased
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
5.9%
1/17 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
16.7%
1/6 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
16.7%
1/6 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
14.3%
1/7 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
16.7%
1/6 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
14.3%
1/7 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
14.3%
1/7 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/9 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/17 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/7 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
0.00%
0/6 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
11.1%
1/9 • Number of events 1 • The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60