Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD (NCT NCT03763318)
NCT ID: NCT03763318
Last Updated: 2026-06-11
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/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Study Day 85
Results posted on
2026-06-11
Participant Flow
Part B of the study was not conducted.
Participant milestones
| Measure |
EQ001 Dose Escalation (Part A) 0.4mg/kg
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Dose Escalation (Part A) 0.8mg/kg
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.8mg/kg
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Dose Escalation (Part A) 1.6mg/kg
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 1.6mg/kg
EQ001: Itolizumab \[Bmab 600\]
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
17
|
9
|
|
Overall Study
COMPLETED
|
3
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
10
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
Baseline characteristics by cohort
| Measure |
EQ001 Dose Escalation (Part A) 0.4mg/kg
n=4 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Dose Escalation (Part A) 0.8mg/kg
n=17 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.8mg/kg
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Dose Escalation (Part A) 1.6mg/kg
n=9 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 1.6mg/kg
EQ001: Itolizumab \[Bmab 600\]
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 18.03 • n=20 Participants
|
60.1 years
STANDARD_DEVIATION 10.86 • n=20 Participants
|
54.6 years
STANDARD_DEVIATION 12.98 • n=40 Participants
|
56.3 years
STANDARD_DEVIATION 13.22 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
10 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
20 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
26 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Study Day 85Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Outcome measures
| Measure |
EQ001 Dose Escalation (Part A) 0.4mg/kg
n=4 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg
EQ001: Itolizumab \[Bmab 600\])
|
EQ001 Dose Escalation (Part A) 0.8mg/kg
n=17 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.8mg/kg
EQ001: Itolizumab \[Bmab 600\])
|
EQ001 Dose Escalation (Part A) 1.6mg/kg
n=9 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 1.6mg/kg
EQ001: Itolizumab \[Bmab 600\])
|
|---|---|---|---|
|
Number of Treatment Emergent Adverse Events
|
4 Participants
|
17 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Study Day 29Overall Response Rate (ORR) is defined as the number of subjects with a partial response (PR), very good partial response (VGPR), or complete response (CR) who are alive at Day 29. Subjects must not have received new systemic therapy for aGVHD before the Day 29 Visit.
Outcome measures
| Measure |
EQ001 Dose Escalation (Part A) 0.4mg/kg
n=4 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg
EQ001: Itolizumab \[Bmab 600\])
|
EQ001 Dose Escalation (Part A) 0.8mg/kg
n=17 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.8mg/kg
EQ001: Itolizumab \[Bmab 600\])
|
EQ001 Dose Escalation (Part A) 1.6mg/kg
n=9 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 1.6mg/kg
EQ001: Itolizumab \[Bmab 600\])
|
|---|---|---|---|
|
Overall Response Rate
|
2 Participants
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 337Time to maximum EQ001 serum concentration, Tmax
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 337Maximum EQ001 serum drug concentration, Cmax
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 337Minimum EQ001 serum drug concentration prior to next dose, Cmin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 337Total EQ001 exposure across time, AUC (from zero to infinity)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 337Half life of EQ001, t1/2
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 337Volume of distribution of EQ001, Vd
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 337Clearance, Cl
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 337Including but not limited to: IL-1β, IL-2, IL-6, IL-17, IL-21, IL-22, IL-23, IFN-γ, and TGF-β, C-reactive protein
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 85CD6 receptor expression levels - percent of baseline
Outcome measures
| Measure |
EQ001 Dose Escalation (Part A) 0.4mg/kg
n=4 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg
EQ001: Itolizumab \[Bmab 600\])
|
EQ001 Dose Escalation (Part A) 0.8mg/kg
n=17 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.8mg/kg
EQ001: Itolizumab \[Bmab 600\])
|
EQ001 Dose Escalation (Part A) 1.6mg/kg
n=9 Participants
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 1.6mg/kg
EQ001: Itolizumab \[Bmab 600\])
|
|---|---|---|---|
|
CD6 Receptor Expression Levels
|
81.0 Percent of baseline
Standard Deviation 17.78
|
23.7 Percent of baseline
Standard Deviation 15.76
|
33.0 Percent of baseline
Standard Deviation 19.25
|
Adverse Events
EQ001 Dose Escalation (Part A) 1.6mg/kg
Serious events: 8 serious events
Other events: 9 other events
Deaths: 6 deaths
EQ001 Dose Escalation (Part A) 0.4mg/kg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
EQ001 Dose Escalation (Part A) 0.8mg/kg
Serious events: 9 serious events
Other events: 17 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
EQ001 Dose Escalation (Part A) 1.6mg/kg
n=9 participants at risk
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 1.6mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Dose Escalation (Part A) 0.4mg/kg
n=4 participants at risk
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Dose Escalation (Part A) 0.8mg/kg
n=17 participants at risk
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.8mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
|---|---|---|---|
|
Infections and infestations
Sepsis
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
52.9%
9/17 • Number of events 9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Adenovirus infection
|
88.9%
8/9 • Number of events 8 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Arthritis bacterial
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Klebsiella sepsis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Nocardiosis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
pulmonary mucormycosis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Pulmonary sepsis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Skin infection
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Atrial flutter
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Pulseless electrical activity
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Intestinal infarction
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Physical deconditioning
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Hepatobiliary disorders
Cholecystitis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Hepatobiliary disorders
Hepatitis fulminant
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Cognitive disorder
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
Other adverse events
| Measure |
EQ001 Dose Escalation (Part A) 1.6mg/kg
n=9 participants at risk
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 1.6mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Dose Escalation (Part A) 0.4mg/kg
n=4 participants at risk
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.4mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Dose Escalation (Part A) 0.8mg/kg
n=17 participants at risk
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses at 0.8mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
66.7%
6/9 • Number of events 6 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
50.0%
2/4 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
52.9%
9/17 • Number of events 9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
35.3%
6/17 • Number of events 6 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Generalised oedema
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Asthenia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
55.6%
5/9 • Number of events 5 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
44.4%
4/9 • Number of events 4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
35.3%
6/17 • Number of events 6 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
29.4%
5/17 • Number of events 5 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
3/9 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
50.0%
2/4 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Platelet count decreased
|
33.3%
3/9 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
52.9%
9/17 • Number of events 9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Blood alkaline phosphate increased
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Neutrophil count decreased
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
3/9 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Blood creatinine increased
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
International normalised ratio increased
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
White blood cell count decreased
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
3/9 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Sepsis
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Blood and lymphatic system disorders
Anaemia
|
44.4%
4/9 • Number of events 4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
29.4%
5/17 • Number of events 5 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Injury, poisoning and procedural complications
Contusion
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Psychiatric disorders
Agitation
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
3/9 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Renal and urinary disorders
Acute kidney injury
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Renal and urinary disorders
Dysuria
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Eye disorders
Vision blurred
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Endocrine disorders
Adrenal insufficiency
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Hepatobiliary disorders
Cholecystitis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Chest Pain
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Localised oedema
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Mucosal dryness
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
General disorders
Physical deconditioning
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hyperferritinaemia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Anal fissure
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Colitis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Haemorrhoids
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Intestinal infarction
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Blood urea increased
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Corona virus test positive
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Ejection fraction decreased
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Liver function test increased
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Investigations
Transaminases increased
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Adenovirus infection
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Arthritis bacterial
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
BK virus infection
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Candida infection
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Enterococcal bacteraemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Klebsiella sepsis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Nocardiosis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Pulmonary mucormycosis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Pulmonary sepsis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Skin infection
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Skin and subcutaneous tissue disorders
Skin weeping
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Atrial flutter
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Pulseless electrical activity
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Psychiatric disorders
Intensive care unit delirium
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Psychiatric disorders
Irritability
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Cognitive disorder
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Renal and urinary disorders
Nephrolithiasis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Vascular disorders
Angiopathy
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Vascular disorders
Embolism
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Eye disorders
Eye irritation
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Eye disorders
Scleral haemorrhage
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Hepatobiliary disorders
Hepatitis fulminant
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Reproductive system and breast disorders
Azoospermia
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/9 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
|
Surgical and medical procedures
Dental implantation
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/4 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
0.00%
0/17 • Adverse Events (AEs) were collected from signing of the informed consent form through the long-term follow-up visit at Day 337.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60