Trial Outcomes & Findings for Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant (NCT NCT05305040)

NCT ID: NCT05305040

Last Updated: 2024-05-16

Results Overview

The average number of clinically significant infections or episodes of end-organ disease per participant due to Adenovirus (AdV), BK virus (BKV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human herpes virus 6 (HHV-6), or JC virus (JCV).

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 451 participants
• Primary outcome timeframe: Through Week 14
• Results posted on: 2024-05-16

Participant Flow

Participants at high risk for viral infection after allogeneic Hematopoietic Cell Transplant were enrolled in the Phase 3 portion of study P-105-202 between Mar 2022 and Jan 2024. The Phase 3 study was discontinued in Dec 2023 after futility analysis of the Primary Outcome Measure. No safety concerns were identified. The Phase 2 portion of study P-105-202 is reported under NCT number NCT04693637.

A total of 451 participants were enrolled in this Phase 3 study. Due to the early termination of this study, 74 were not dosed. The 377 randomized participants that were dosed comprise the Safety Population.

Participant milestones

Measure	Posoleucel (ALVR105) Participants received posoleucel administered as 2-4 mL intravenous (IV) infusion once every 14 days for 7 doses.	Placebo Participants received placebo administered as 2-4 mL IV infusion once every 14 days for 7 doses.
Overall Study STARTED	225	226
Overall Study Participants Dosed (Safety Population)	188	189
Overall Study COMPLETED	100	101
Overall Study NOT COMPLETED	125	125

Reasons for withdrawal

Measure	Posoleucel (ALVR105) Participants received posoleucel administered as 2-4 mL intravenous (IV) infusion once every 14 days for 7 doses.	Placebo Participants received placebo administered as 2-4 mL IV infusion once every 14 days for 7 doses.
Overall Study Not Dosed	37	37
Overall Study Study Closure	34	46
Overall Study Death	14	13
Overall Study Withdrawal by Subject	15	10
Overall Study Other	13	10
Overall Study Primary Malignancy Relapse	3	4
Overall Study Adverse Event	3	3
Overall Study Lost to Follow-up	2	1
Overall Study Graft versus host disease	2	0
Overall Study Investigator's Decision	1	1
Overall Study COVID-19 Reasons	1	0

Baseline Characteristics

Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Baseline characteristics by cohort

Measure	Posoleucel (ALVR105) n=188 Participants Participants received posoleucel administered as 2-4 mL IV infusion once every 14 days for 7 doses.	Placebo n=189 Participants Participants received placebo administered as 2-4 mL IV infusion once every 14 days for 7 doses.	Total n=377 Participants Total of all reporting groups
Age, Continuous	55.0 years n=5 Participants	53.0 years n=7 Participants	54.0 years n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	66 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	110 Participants n=5 Participants	123 Participants n=7 Participants	233 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	24 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	143 Participants n=5 Participants	144 Participants n=7 Participants	287 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants	21 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	118 Participants n=5 Participants	131 Participants n=7 Participants	249 Participants n=5 Participants
Race/Ethnicity, Customized Other	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through Week 14

Population: Includes modified Intent-to-Treat (mITT) Population comprised of all randomized participants who received study drug and completed through Week 14 visit.

The average number of clinically significant infections or episodes of end-organ disease per participant due to Adenovirus (AdV), BK virus (BKV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human herpes virus 6 (HHV-6), or JC virus (JCV).

Outcome measures

Measure	Posoleucel (ALVR105) n=159 Participants Participants received posoleucel administered as 2-4 mL IV infusion once every 14 days for 7 doses.	Placebo n=155 Participants Participants received placebo administered as 2-4 mL IV infusion once every 14 days for 7 doses.
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14	0.2 Infections/Episodes per participant Standard Deviation 0.44	0.2 Infections/Episodes per participant Standard Deviation 0.42

SECONDARY outcome

Timeframe: Through Week 26

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

The number of clinically significant infections or episodes of end-organ disease per participant due to AdV, BKV, CMV, EBV, HHV-6, or JCV.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through Week 14

Population: Includes mITT Population comprised of all randomized participants who received study drug and completed through Week 14 visit.

The number of participants with clinically significant infections or episodes of end-organ disease due to each of the following viruses: AdV, BKV, CMV, EBV, HHV-6, or JCV.

Outcome measures

Measure	Posoleucel (ALVR105) n=159 Participants Participants received posoleucel administered as 2-4 mL IV infusion once every 14 days for 7 doses.	Placebo n=155 Participants Participants received placebo administered as 2-4 mL IV infusion once every 14 days for 7 doses.
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus EBV	10 participants	6 participants
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus AdV	3 participants	2 participants
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus BKV	2 participants	2 participants
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus CMV	16 participants	19 participants
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus HHV-6	0 participants	0 participants
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus JCV	0 participants	0 participants

Adverse Events

Posoleucel (ALVR105)

Serious events: 88 serious events

Other events: 180 other events

Deaths: 18 deaths

Placebo

Serious events: 86 serious events

Other events: 184 other events

Deaths: 19 deaths

Serious adverse events

Measure	Posoleucel (ALVR105) n=188 participants at risk Participants received posoleucel administered as 2-4 mL IV infusion once every 14 days for 7 doses.	Placebo n=189 participants at risk Participants received placebo administered as a 2-4 mL IV infusion once every 14 days for 7 doses.
Blood and lymphatic system disorders Febrile neutropenia	2.1% 4/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	3.2% 6/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Anaemia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Cytopenia	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Leukocytosis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Warm autoimmune haemolytic anaemia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Cardiac disorders Cardiac arrest	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.6% 3/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Cardiac disorders Cardiac failure	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Cardiac disorders Pericardial effusion	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Cardiac disorders Pericarditis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Cardiac disorders Cardio-respiratory arrest	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Congenital, familial and genetic disorders Aplasia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Eye disorders Papilloedema	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Eye disorders Strabismus	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Diarrhoea	3.2% 6/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	2.1% 4/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Vomiting	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.6% 3/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Abdominal pain	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Barrett's oesophagus	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Colitis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Intestinal obstruction	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Nausea	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Small intestinal obstruction	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Pyrexia	2.1% 4/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	6.3% 12/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Disease progression	1.6% 3/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Asthenia	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Chills	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Fatigue	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders General physical health deterioration	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Influenza like illness	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Malaise	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Non-cardiac chest pain	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Systemic inflammatory response syndrome	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Hepatobiliary disorders Bile duct stone	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Hepatobiliary disorders Cholelithiasis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Hepatobiliary disorders Hepatic necrosis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Hepatobiliary disorders Hypertransaminasaemia	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Graft versus host disease in gastrointestinal tract	3.7% 7/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	3.7% 7/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Acute graft versus host disease in skin	2.1% 4/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Acute graft versus host disease in intestine	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.6% 3/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Graft versus host disease in liver	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Acute graft versus host disease	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Graft versus host disease	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Graft versus host disease in skin	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Acute graft versus host disease in liver	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Chronic graft versus host disease in skin	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Autoimmune disorder	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Chronic graft versus host disease	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Chronic graft versus host disease in liver	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Cytokine release syndrome	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations COVID-19	2.7% 5/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	2.1% 4/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Pneumonia	2.1% 4/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	2.1% 4/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Cytomegalovirus infection	1.6% 3/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	2.1% 4/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Sepsis	2.7% 5/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Bacteraemia	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	2.1% 4/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Cytomegalovirus infection reactivation	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	2.1% 4/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Adenovirus infection	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.6% 3/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Epstein-Barr viraemia	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Cytomegalovirus viraemia	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Gastroenteritis	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Clostridium difficile colitis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Clostridium difficile infection	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Device related bacteraemia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Epstein-Barr virus infection reactivation	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Herpes zoster	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Klebsiella bacteraemia	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Klebsiella sepsis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Norovirus infection	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Parainfluenzae virus infection	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Pneumococcal sepsis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Toxoplasmosis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Viral haemorrhagic cystitis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Adenoviral haemorrhagic cystitis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Adenovirus reactivation	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Anorectal infection	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Aspergillus infection	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Bacterial sepsis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Catheter site infection	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Clostridial sepsis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations COVID-19 pneumonia	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Cystitis viral	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Device related infection	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Endocarditis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Enterobacter bacteraemia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Enterocolitis bacterial	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Epstein-Barr virus infection	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Fungal infection	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Herpes simplex	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Human bocavirus infection	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Human herpesvirus 6 infection reactivation	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Meningitis aseptic	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Paronychia	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Respiratory tract infection viral	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Rotavirus infection	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Septic shock	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Sinusitis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Systemic candida	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Tracheobronchitis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Upper respiratory tract infection	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Urinary tract infection	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Vascular device infection	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Injury, poisoning and procedural complications Transplant failure	1.6% 3/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Injury, poisoning and procedural complications Fall	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Injury, poisoning and procedural complications Femoral neck fracture	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Injury, poisoning and procedural complications Subdural haemorrhage	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Enterobacter test positive	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Epstein-Barr virus antigen positive	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Epstein-Barr virus test positive	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Herpes simplex test positive	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Human rhinovirus test positive	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Influenza A virus test positive	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Liver function test abnormal	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Liver function test increased	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Neutrophil count decreased	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Respiratory syncytial virus test positive	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Decreased appetite	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Dehydration	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Hyperkalaemia	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	3.2% 6/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	1.1% 2/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post transplant lymphoproliferative disorder	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia recurrent	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia recurrent	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia recurrent	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Precursor T-lymphoblastic lymphoma/leukaemia recurrent	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Headache	1.6% 3/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Haemorrhage intracranial	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Central nervous system lesion	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Cerebellar haematoma	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Cerebral haemorrhage	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Neuropathy peripheral	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Status epilepticus	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Transient aphasia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Psychiatric disorders Confusional state	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Psychiatric disorders Mental status changes	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Renal and urinary disorders Acute kidney injury	2.1% 4/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 4/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.6% 3/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Vascular disorders Shock haemorrhagic	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.1% 2/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Vascular disorders Hypertensive crisis	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Vascular disorders Hypotension	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Vascular disorders Hypovolaemic shock	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Cardiac disorders Cardio-respiratory arrest with sepsis	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Fever and rigors	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Hospitalization for nausea and vomiting	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Positive cultures from indwelling CVAD	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Sepsis with multiple organ failure	0.53% 1/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.00% 0/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Sepsis with fever and rigor	0.00% 0/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	0.53% 1/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.

Other adverse events

Measure	Posoleucel (ALVR105) n=188 participants at risk Participants received posoleucel administered as 2-4 mL IV infusion once every 14 days for 7 doses.	Placebo n=189 participants at risk Participants received placebo administered as a 2-4 mL IV infusion once every 14 days for 7 doses.
Blood and lymphatic system disorders Anaemia	13.8% 26/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	12.7% 24/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Thrombocytopenia	3.2% 6/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	7.4% 14/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Febrile neutropenia	5.3% 10/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	4.8% 9/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Blood and lymphatic system disorders Neutropenia	6.4% 12/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	3.7% 7/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Eye disorders Dry eye	2.7% 5/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	6.9% 13/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Diarrhoea	24.5% 46/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	19.6% 37/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Nausea	19.1% 36/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	11.6% 22/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Vomiting	15.4% 29/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	11.1% 21/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Abdominal pain	13.3% 25/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	8.5% 16/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Gastrointestinal disorders Constipation	6.4% 12/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	5.3% 10/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Pyrexia	17.6% 33/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	19.0% 36/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Fatigue	11.7% 22/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	9.0% 17/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Oedema peripheral	9.0% 17/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	10.6% 20/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
General disorders Asthenia	5.9% 11/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	4.2% 8/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Acute graft versus host disease in skin	19.1% 36/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	14.3% 27/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Graft versus host disease in gastrointestinal tract	12.8% 24/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	8.5% 16/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Graft versus host disease in skin	8.0% 15/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	7.9% 15/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Acute graft versus host disease	5.9% 11/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	3.7% 7/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Immune system disorders Hypogammaglobulinaemia	3.2% 6/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	6.3% 12/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Cytomegalovirus infection	6.9% 13/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	9.5% 18/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Pneumonia	5.9% 11/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	7.4% 14/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations COVID-19	6.9% 13/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	5.8% 11/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Cytomegalovirus infection reactivation	5.3% 10/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	5.8% 11/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Upper respiratory tract infection	2.7% 5/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	7.4% 14/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Infections and infestations Sepsis	5.3% 10/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	1.6% 3/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Injury, poisoning and procedural complications Fall	4.3% 8/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	5.3% 10/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Blood creatinine increased	16.0% 30/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	11.6% 22/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Platelet count decreased	11.7% 22/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	7.9% 15/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Alanine aminotransferase increased	7.4% 14/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	8.5% 16/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Aspartate aminotransferase increased	4.8% 9/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	5.8% 11/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations White blood cell count decreased	6.4% 12/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	4.2% 8/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Investigations Neutrophil count decreased	5.3% 10/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	4.2% 8/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Decreased appetite	9.6% 18/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	11.6% 22/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Hypokalaemia	12.2% 23/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	6.3% 12/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Hypomagnesaemia	10.1% 19/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	6.9% 13/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Hyperglycaemia	9.6% 18/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	5.8% 11/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Metabolism and nutrition disorders Hyponatraemia	5.3% 10/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	3.7% 7/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 8/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	5.8% 11/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Headache	11.7% 22/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	11.6% 22/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Tremor	7.4% 14/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	5.8% 11/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Nervous system disorders Dizziness	5.3% 10/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	6.3% 12/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Psychiatric disorders Insomnia	5.9% 11/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	3.7% 7/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Renal and urinary disorders Acute kidney injury	7.4% 14/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	3.2% 6/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Cough	16.0% 30/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	10.6% 20/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.4% 14/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	11.6% 22/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.8% 9/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	7.4% 14/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.3% 10/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	2.6% 5/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Skin and subcutaneous tissue disorders Pruritus	9.0% 17/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	7.4% 14/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Skin and subcutaneous tissue disorders Rash	8.5% 16/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	7.4% 14/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.0% 17/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	6.3% 12/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Skin and subcutaneous tissue disorders Erythema	5.9% 11/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	4.8% 9/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Skin and subcutaneous tissue disorders Dry skin	5.3% 10/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	4.8% 9/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.
Vascular disorders Hypertension	8.5% 16/188 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.	3.7% 7/189 • Day 1 through Week 26. Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.

Additional Information

Kevin Anderson

AlloVir, Inc.

Phone: 617-433-2605

Email: kanderson@allovir.com

Results disclosure agreements

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