Trial Outcomes & Findings for Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC) (NCT NCT04390113)

NCT ID: NCT04390113

Last Updated: 2024-05-14

Results Overview

Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 97 participants
• Primary outcome timeframe: Up to 24 weeks
• Results posted on: 2024-05-14

Participant Flow

Participants were enrolled from March 2021 to Jan 2024 across 57 study centers in the United States, Canada, France, Italy, Spain, Sweden, the United Kingdom and South Korea.

Overall 144 participants were screened and a total of 97 participants were randomized in the study.

Participant milestones

Measure	Posoleucel (ALVR105) All participants received 2 infusions of either posoleucel (PSL) or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered intravenously (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	Placebo All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
Overall Study STARTED	57	40
Overall Study COMPLETED	37	26
Overall Study NOT COMPLETED	20	14

Reasons for withdrawal

Measure	Posoleucel (ALVR105) All participants received 2 infusions of either posoleucel (PSL) or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered intravenously (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	Placebo All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
Overall Study Not Treated	0	1
Overall Study Adverse Event	1	0
Overall Study Death	2	1
Overall Study Physician Decision	1	3
Overall Study Study Terminated by Sponsor	5	3
Overall Study Withdrawal by Subject	10	5
Overall Study Other	1	0
Overall Study Missing	0	1

Baseline Characteristics

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)

Baseline characteristics by cohort

Measure	Posoleucel (ALVR105) n=57 Participants All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	Placebo n=40 Participants All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	Total n=97 Participants Total of all reporting groups
Age, Continuous	44.9 years STANDARD_DEVIATION 16.59 • n=5 Participants	47.0 years STANDARD_DEVIATION 16.60 • n=7 Participants	45.8 years STANDARD_DEVIATION 16.54 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	24 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	30 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: BK Intent-to-Treat \[ITT\] Population: All patients randomized who had BKV in their urine at baseline.

Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study.

Outcome measures

Measure	Posoleucel (ALVR105) n=48 Participants All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	Placebo n=38 Participants All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
Time to Resolution of Macroscopic Hematuria	36 Days Interval 22.0 to 63.0	31 Days Interval 18.0 to 63.0

SECONDARY outcome

Timeframe: Until event occurrence through Week 24

Population: Data not collected due to early termination after Data and Safety Monitoring Board (DSMB) futility analysis concluded the study was unlikely to meet its primary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until event occurrence through Week 24

Population: Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Modified ITT Population (mITT): All randomized participants who receive any dose of study drug.

Grading of acute GVHD is reported according to CTCAE version 5.0 which ranges from Grade 0 (best/no disease) to Grade IV (worst). Participants with Grade I-IV are included.

Outcome measures

Measure	Posoleucel (ALVR105) n=57 Participants All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	Placebo n=39 Participants All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)	11 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: mITT: All randomized participants who receive any dose of study drug.

CRS is defined as a supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms can be progressive, must include fever at the onset, and may include hypotension, capillary leak (hypoxia), and end organ dysfunction.

Outcome measures

Measure	Posoleucel (ALVR105) n=57 Participants All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	Placebo n=39 Participants All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Until event occurrence through Week 24

Population: Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until event occurrence through Week 6

Population: Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.

Outcome measures

Outcome data not reported

Adverse Events

Posoleucel (ALVR105)

Serious events: 28 serious events

Other events: 54 other events

Deaths: 2 deaths

Placebo

Serious events: 19 serious events

Other events: 36 other events

Deaths: 1 deaths

Serious adverse events

Measure	Posoleucel (ALVR105) n=57 participants at risk All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	Placebo n=39 participants at risk All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
Infections and infestations Pneumonia	7.0% 4/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Viral haemorrhagic cystitis	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations COVID-19 pneumonia	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Clostridium difficile colitis	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Sinusitis	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Bacterial pyelonephritis	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Bacterial sepsis	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations COVID-19	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Cellulitis	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Escherichia bacteraemia	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Gastroenteritis salmonella	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Human herpesvirus 6 encephalitis	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Kidney infection	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Klebsiella bacteraemia	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Lower respiratory tract infection	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Mastoiditis	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Otitis media acute	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Pneumonia escherichia	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Pneumonia staphylococcal	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Post-acute COVID-19 syndrome	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Respiratory syncytial virus infection	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Sepsis	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Septic shock	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Upper respiratory tract infection	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Urinary tract infection	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Urinary tract infection bacterial	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Urinary tract infection pseudomonal	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Painful respiration	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Acute kidney injury	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Urinary retention	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Anuria	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Cystitis haemorrhagic	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Dysuria	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Viral haemorrhagic cystitis	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Nausea	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Vomiting	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Diarrhoea	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
General disorders Abdominal pain	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
General disorders Pyrexia	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
General disorders Asthenia	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
General disorders Non-cardiac chest pain	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Humerus fracture	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Toxicity to various agents	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Transfusion reaction	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Transplant failure	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Febrile neutropenia	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Anaemia	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Acute graft versus host disease in intestine	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Acute graft versus host disease in liver	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Chronic graft versus host disease in intestine	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Nervous system disorders Dizziness	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Nervous system disorders Encephalopathy	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Nervous system disorders Headache	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Nervous system disorders Seizure	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Cardiac disorders Cardiac failure congestive	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Cardiac disorders Pericarditis	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Cardiac disorders Tachycardia	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Vascular disorders Hypotension	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Vascular disorders Shock haemorrhagic	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations Lipase increased	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Decreased appetite	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Surgical and medical procedures Arterial revascularisation	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.

Other adverse events

Measure	Posoleucel (ALVR105) n=57 participants at risk All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	Placebo n=39 participants at risk All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
Infections and infestations Pneumonia	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	10.3% 4/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations COVID-19	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Urinary tract infection	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	12.8% 5/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Cytomegalovirus infection reactivation	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Oral candidiasis	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Epstein-Barr virus infection reactivation	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Upper respiratory tract infection	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Viral haemorrhagic cystitis	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Diarrhoea	22.8% 13/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	20.5% 8/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Nausea	19.3% 11/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	17.9% 7/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Vomiting	12.3% 7/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Constipation	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Gastrointestinal disorders Dry mouth	7.0% 4/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations Blood creatinine increased	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	15.4% 6/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations Neutrophil count decreased	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	12.8% 5/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations Platelet count decreased	12.3% 7/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations White blood cell count decreased	8.8% 5/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations Aspartate aminotransferase increased	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations Blood alkaline phosphatase increased	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	10.3% 4/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations Alanine aminotransferase increased	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations Blood lactate dehydrogenase increased	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	10.3% 4/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypokalaemia	15.8% 9/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	20.5% 8/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Decreased appetite	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	12.8% 5/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypomagnesaemia	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypophosphataemia	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Acute graft versus host disease in intestine	14.0% 8/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Acute graft versus host disease in skin	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	12.8% 5/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Chronic graft versus host disease in skin	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Chronic graft versus host disease in intestine	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Chronic graft versus host disease in eye	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
General disorders Pyrexia	19.3% 11/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	20.5% 8/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
General disorders Oedema peripheral	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	10.3% 4/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
General disorders Fatigue	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Cough	8.8% 5/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.0% 4/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Dysuria	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Acute kidney injury	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Anaemia	7.0% 4/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	23.1% 9/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Neutropenia	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Febrile neutropenia	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	17.9% 7/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Vascular disorders Hypotension	10.5% 6/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	10.3% 4/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Vascular disorders Hypertension	7.0% 4/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Nervous system disorders Headache	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Psychiatric disorders Confusional state	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Psychiatric disorders Depression	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Fall	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Cardiac disorders Tachycardia	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Eye disorders Dry eye	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Thrombocytopenia	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Cardiac disorders Pericardial effusion	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Acute graft versus host disease in liver	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Chronic graft versus host disease oral	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Adenovirus infection	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Parainfluenzae virus infection	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Urinary tract infection bacterial	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Infections and infestations Cytomegalovirus viraemia	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Blood bilirubin increased	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations Gamma-glutamyltransferase increased	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Investigations C-reactive protein increased	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperglycaemia	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyponatraemia	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	2.6% 1/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypocalcaemia	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Flank pain	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Pain in extremity	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Nervous system disorders Dysgeusia	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	7.7% 3/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Psychiatric disorders Hallucination	1.8% 1/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Psychiatric disorders Insomnia	5.3% 3/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Psychiatric disorders Agitation	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Pruritus	3.5% 2/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Haematuria	7.0% 4/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Urinary retention	7.0% 4/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	0.00% 0/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/57 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.	5.1% 2/39 • Up to 24 weeks All-cause Mortality was collected for all participants enrolled. Serious and Other (not including serious) Adverse Events were collected for participants who received at least one dose of investigational product.

Additional Information

Senior Vice President

AlloVir, Inc.

Phone: +1 617-433-2605

Email: rriese@allovir.com

Results disclosure agreements

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