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: 2025-04-18

Results Overview

Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: Study Day 85
• Results posted on: 2025-04-18

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=5 Participants	60.1 years STANDARD_DEVIATION 10.86 • n=7 Participants	54.6 years STANDARD_DEVIATION 12.98 • n=5 Participants	56.3 years STANDARD_DEVIATION 13.22 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	14 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Study Day 85

Number 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 29

Overall 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 337

Time to maximum EQ001 serum concentration, Tmax

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study Day 337

Maximum EQ001 serum drug concentration, Cmax

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study Day 337

Minimum EQ001 serum drug concentration prior to next dose, Cmin

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study Day 337

Total EQ001 exposure across time, AUC (from zero to infinity)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study Day 337

Half life of EQ001, t1/2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study Day 337

Volume of distribution of EQ001, Vd

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study Day 337

Clearance, Cl

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study Day 337

Including 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 85

CD6 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) 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

EQ001 Dose Escalation (Part A) 1.6mg/kg

Serious events: 8 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Measure	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 \[Bmab 600\]	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 \[Bmab 600\]
Infections and infestations Sepsis	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.	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.
Infections and infestations Adenovirus infection	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.	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.
Infections and infestations Arthritis bacterial	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.	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.
Infections and infestations COVID-19	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.	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.
Infections and infestations COVID-19 pneumonia	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.	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.
Infections and infestations Klebsiella sepsis	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.	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.
Infections and infestations Nocardiosis	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.	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.
Infections and infestations pulmonary mucormycosis	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.	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.
Infections and infestations Pulmonary sepsis	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.	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.
Infections and infestations Skin infection	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.	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.
Infections and infestations Staphylococcal sepsis	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.	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.
Immune system disorders Graft versus host disease	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.	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.
Immune system disorders Graft versus host disease in gastrointestinal tract	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.	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.
Immune system disorders Acute graft versus host disease	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.	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.
Cardiac disorders Cardiac arrest	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.	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.
Cardiac disorders Atrial fibrillation	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.	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.
Cardiac disorders Atrial flutter	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.	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.
Cardiac disorders Pulseless electrical activity	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.	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.
Gastrointestinal disorders Diarrhoea	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.	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.
Gastrointestinal disorders Intestinal infarction	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.	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.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	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.	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.
Gastrointestinal disorders Retroperitoneal haemorrhage	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.	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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	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.	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.
Respiratory, thoracic and mediastinal disorders Hypoxia	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.	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.
General disorders Physical deconditioning	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.	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.
General disorders Pyrexia	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.	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.
Hepatobiliary disorders Cholecystitis	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.	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.
Hepatobiliary disorders Hepatic cirrhosis	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.	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.
Hepatobiliary disorders Hepatitis fulminant	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.	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.
Injury, poisoning and procedural complications Wound dehiscence	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.	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.
Musculoskeletal and connective tissue disorders Myopathy	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.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	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.	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.
Nervous system disorders Cognitive disorder	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.	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.
Psychiatric disorders Substance-induced psychotic disorder	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.	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.

Other adverse events

Measure	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 \[Bmab 600\]	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 \[Bmab 600\]
Infections and infestations COVID-19	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.	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.
Infections and infestations COVID-19 pneumonia	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.	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.
Infections and infestations Candida infection	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.	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.
Infections and infestations Clostridium difficile colitis	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.	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.
Infections and infestations Clostridium difficile infection	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.	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.
Infections and infestations Cytomegalovirus infection reactivation	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.	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.
Infections and infestations Cytomegalovirus viraemia	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.	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.
Infections and infestations Endocarditis	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.	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.
Infections and infestations Enterococcal bacteraemia	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.	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.
General disorders Oedema peripheral	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.	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.
General disorders Fatigue	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.	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.
General disorders Chills	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.	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.
General disorders Generalised oedema	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.	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.
General disorders Asthenia	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.	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.
General disorders Pyrexia	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.	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.
Metabolism and nutrition disorders Hypokalaemia	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.	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.
Metabolism and nutrition disorders Hypomagnesaemia	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.	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.
Metabolism and nutrition disorders Hyperglycaemia	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.	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.
Metabolism and nutrition disorders Decreased appetite	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.	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.
Metabolism and nutrition disorders Hyperkalaemia	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.	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.
Metabolism and nutrition disorders Hypoalbuminaemia	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.	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.
Metabolism and nutrition disorders Hypophosphataemia	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.	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.
Metabolism and nutrition disorders Hypermagnesaemia	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.	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.
Metabolism and nutrition disorders Hyponatraemia	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.	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.
Metabolism and nutrition disorders Dehydration	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.	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.
Metabolism and nutrition disorders Hypercalcaemia	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.	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.
Metabolism and nutrition disorders Hypernatraemia	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.	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.
Metabolism and nutrition disorders Hyperuricaemia	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.	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.
Metabolism and nutrition disorders Vitamin D deficiency	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.	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.
Gastrointestinal disorders Diarrhoea	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.	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.
Gastrointestinal disorders Abdominal pain	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.	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.
Gastrointestinal disorders Dry mouth	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.	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.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	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.	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.
Gastrointestinal disorders Abdominal distension	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.	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.
Gastrointestinal disorders Gastrooesophageal reflux disease	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.	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.
Gastrointestinal disorders Nausea	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.	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.
Gastrointestinal disorders Stomatitis	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.	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.
Gastrointestinal disorders Vomiting	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.	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.
Investigations Platelet count decreased	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.	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.
Investigations Blood alkaline phosphate increased	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.	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.
Investigations Neutrophil count decreased	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.	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.
Investigations Alanine aminotransferase increased	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.	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.
Investigations Lymphocyte count decreased	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.	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.
Investigations Aspartate aminotransferase increased	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.	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.
Investigations Blood bilirubin increased	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.	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.
Investigations Blood creatinine increased	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.	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.
Investigations Gamma-glutamyltransferase increased	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.	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.
Investigations International normalised ratio increased	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.	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.
Investigations White blood cell count decreased	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.	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.
Investigations Blood lactic acid increased	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.	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.
Infections and infestations Urinary tract infection	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.	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.
Infections and infestations Bacteraemia	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.	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.
Infections and infestations Cytomegalovirus infection	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.	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.
Infections and infestations Sepsis	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.	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.
Respiratory, thoracic and mediastinal disorders Epistaxis	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.	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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	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.	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.
Respiratory, thoracic and mediastinal disorders Cough	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.	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.
Respiratory, thoracic and mediastinal disorders Hiccups	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.	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.
Respiratory, thoracic and mediastinal disorders Hypoxia	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.	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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	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.	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.
Skin and subcutaneous tissue disorders Skin ulcer	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.	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.
Skin and subcutaneous tissue disorders Erythema	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.	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.
Skin and subcutaneous tissue disorders Skin exfoliation	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.	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.
Blood and lymphatic system disorders Anaemia	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.	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.
Blood and lymphatic system disorders Neutropenia	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.	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.
Blood and lymphatic system disorders Thrombocytopenia	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.	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.
Injury, poisoning and procedural complications Fall	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.	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.
Injury, poisoning and procedural complications Contusion	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.	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.
Injury, poisoning and procedural complications Infusion related reaction	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.	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.
Musculoskeletal and connective tissue disorders Back pain	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.	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.
Musculoskeletal and connective tissue disorders Muscular weakness	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.	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.
Musculoskeletal and connective tissue disorders Muscle spasms	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.	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.
Musculoskeletal and connective tissue disorders Osteopenia	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.	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.
Musculoskeletal and connective tissue disorders Pain in extremity	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.	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.
Cardiac disorders Sinus tachycardia	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.	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.
Cardiac disorders Atrial fibrillation	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.	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.
Cardiac disorders Cardiac arrest	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.	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.
Psychiatric disorders Insomnia	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.	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.
Psychiatric disorders Agitation	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.	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.
Psychiatric disorders Depression	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.	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.
Psychiatric disorders Confusional state	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.	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.
Nervous system disorders Dizziness	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.	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.
Nervous system disorders Headache	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.	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.
Immune system disorders Graft versus host disease	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.	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.
Immune system disorders Graft versus host disease in gastrointestinal tract	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.	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.
Immune system disorders Hypogammaglobulinaemia	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.	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.
Renal and urinary disorders Haematuria	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.	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.
Renal and urinary disorders Acute kidney injury	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.	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.
Renal and urinary disorders Dysuria	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.	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.
Vascular disorders Hypertension	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.	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.
Vascular disorders Hypotension	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.	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.
Vascular disorders Orthostatic hypotension	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.	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.
Eye disorders Vision blurred	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.	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.
Endocrine disorders Adrenal insufficiency	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.	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.
Hepatobiliary disorders Cholecystitis	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.	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.
General disorders Chest discomfort	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.	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.
General disorders Chest Pain	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.	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.
General disorders Influenza like illness	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.	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.
General disorders Localised oedema	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.	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.
General disorders Mucosal dryness	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.	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.
General disorders Non-cardiac chest pain	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.	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.
General disorders Physical deconditioning	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.	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.
Metabolism and nutrition disorders Gout	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.	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.
Metabolism and nutrition disorders Hyperferritinaemia	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.	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.
Metabolism and nutrition disorders Hypocalcaemia	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.	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.
Metabolism and nutrition disorders Hypoglycaemia	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.	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.
Metabolism and nutrition disorders Lactose intolerance	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.	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.
Metabolism and nutrition disorders Metabolic acidosis	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.	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.
Metabolism and nutrition disorders Vitamin B complex deficiency	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.	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.
Gastrointestinal disorders Abdominal pain lower	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.	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.
Gastrointestinal disorders Abdominal pain upper	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.	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.
Gastrointestinal disorders Anal fissure	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.	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.
Gastrointestinal disorders Ascites	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.	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.
Gastrointestinal disorders Colitis	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.	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.
Gastrointestinal disorders Constipation	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.	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.
Gastrointestinal disorders Dyspepsia	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.	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.
Gastrointestinal disorders Dysphagia	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.	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.
Gastrointestinal disorders Haematochezia	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.	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.
Gastrointestinal disorders Haemorrhoids	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.	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.
Gastrointestinal disorders Ileus	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.	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.
Gastrointestinal disorders Intestinal infarction	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.	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.
Gastrointestinal disorders Retroperitoneal haemorrhage	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.	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.
Investigations Blood albumin decreased	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.	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.
Investigations Blood lactate dehydrogenase increased	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.	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.
Investigations Blood urea increased	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.	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.
Investigations Corona virus test positive	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.	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.
Investigations Ejection fraction decreased	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.	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.
Investigations Electrocardiogram QT prolonged	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.	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.
Investigations Haptoglobin decreased	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.	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.
Investigations Liver function test increased	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.	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.
Investigations Oxygen saturation decreased	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.	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.
Investigations Transaminases increased	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.	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.
Infections and infestations Adenovirus infection	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.	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.
Infections and infestations Arthritis bacterial	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.	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.
Infections and infestations BK virus infection	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.	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.
Infections and infestations Epstein-Barr virus infection reactivation	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.	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.
Infections and infestations Influenza	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.	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.
Infections and infestations Klebsiella sepsis	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.	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.
Infections and infestations Nocardiosis	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.	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.
Infections and infestations Oral candidiasis	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.	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.
Infections and infestations Parainfluenzae virus infection	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.	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.
Infections and infestations Pharyngitis	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.	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.
Infections and infestations Pneumonia	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.	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.
Infections and infestations Pulmonary mucormycosis	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.	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.
Infections and infestations Pulmonary sepsis	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.	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.
Infections and infestations Sialoadenitis	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.	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.
Infections and infestations Skin infection	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.	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.
Infections and infestations Staphylococcal sepsis	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.	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.
Infections and infestations Upper respiratory tract infection	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.	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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	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.	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.
Respiratory, thoracic and mediastinal disorders Atelectasis	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.	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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	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.	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.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	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.	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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	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.	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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	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.	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.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	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.	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.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	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.	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.
Respiratory, thoracic and mediastinal disorders Sneezing	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.	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.
Respiratory, thoracic and mediastinal disorders Wheezing	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.	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.
Skin and subcutaneous tissue disorders Decubitus ulcer	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.	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.
Skin and subcutaneous tissue disorders Dermatitis acneiform	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.	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.
Skin and subcutaneous tissue disorders Dermatitis bullous	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.	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.
Skin and subcutaneous tissue disorders Dermatitis contact	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.	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.
Skin and subcutaneous tissue disorders Dry skin	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.	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.
Skin and subcutaneous tissue disorders Eczema	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.	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.
Skin and subcutaneous tissue disorders Leukoplakia	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.	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.
Skin and subcutaneous tissue disorders Onychomadesis	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.	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.
Skin and subcutaneous tissue disorders Pigmentation disorder	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.	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.
Skin and subcutaneous tissue disorders Pruritus	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.	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.
Skin and subcutaneous tissue disorders Rash	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.	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.
Skin and subcutaneous tissue disorders Rash maculo-papular	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.	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.
Skin and subcutaneous tissue disorders Skin hypopigmentation	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.	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.
Skin and subcutaneous tissue disorders Skin weeping	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.	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.
Blood and lymphatic system disorders Febrile neutropenia	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.	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.
Blood and lymphatic system disorders Leukopenia	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.	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.
Blood and lymphatic system disorders Thrombotic microangiopathy	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.	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.
Injury, poisoning and procedural complications Skin abrasion	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.	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.
Injury, poisoning and procedural complications Spinal compression fracture	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.	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.
Injury, poisoning and procedural complications Thoracic vertebral fracture	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.	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.
Injury, poisoning and procedural complications Vascular access complication	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.	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.
Injury, poisoning and procedural complications Wound dehiscence	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.	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.
Musculoskeletal and connective tissue disorders Arthralgia	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.	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.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	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.	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.
Musculoskeletal and connective tissue disorders Myopathy	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.	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.
Musculoskeletal and connective tissue disorders Neck pain	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.	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.
Musculoskeletal and connective tissue disorders Osteonecrosis	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.	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.
Musculoskeletal and connective tissue disorders Osteoporosis	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.	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.
Cardiac disorders Angina pectoris	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.	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.
Cardiac disorders Atrial flutter	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.	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.
Cardiac disorders Bradycardia	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.	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.
Cardiac disorders Pericardial effusion	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.	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.
Cardiac disorders Pulseless electrical activity	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.	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.
Cardiac disorders Tachycardia	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.	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.
Psychiatric disorders Delirium	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.	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.
Psychiatric disorders Intensive care unit delirium	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.	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.
Psychiatric disorders Irritability	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.	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.
Psychiatric disorders Substance-induced psychotic disorder	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.	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.
Nervous system disorders Cognitive disorder	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.	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.
Nervous system disorders Dizziness postural	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.	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.
Nervous system disorders Dysgeusia	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.	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.
Nervous system disorders Embolic stroke	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.	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.
Nervous system disorders Encephalopathy	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.	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.
Nervous system disorders Hypoaesthesia	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.	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.
Nervous system disorders Lethargy	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.	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.
Nervous system disorders Peripheral sensory neuropathy	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.	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.
Immune system disorders Acute graft versus host disease	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.	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.
Renal and urinary disorders Hydronephrosis	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.	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.
Renal and urinary disorders Nephrolithiasis	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.	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.
Renal and urinary disorders Urinary retention	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.	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.
Vascular disorders Angiopathy	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.	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.
Vascular disorders Embolism	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.	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.
Eye disorders Eye irritation	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.	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.
Eye disorders Lacrimation increased	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.	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.
Eye disorders Scleral haemorrhage	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.	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.
Hepatobiliary disorders Hepatic cirrhosis	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.	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.
Hepatobiliary disorders Hepatitis fulminant	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.	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.
Ear and labyrinth disorders Ear congestion	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.	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.
Ear and labyrinth disorders Tinnitus	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.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	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.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	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.	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.
Reproductive system and breast disorders Azoospermia	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.	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.
Reproductive system and breast disorders Breast pain	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.	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.
Reproductive system and breast disorders Scrotal oedema	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.	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.
Surgical and medical procedures Dental implantation	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.	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.

Additional Information

Clinical Operations

Equillium

Phone: 858-240-1200

Email: clinicaltrials@equilliumbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60