Trial Outcomes & Findings for Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation (NCT NCT05179057)
NCT ID: NCT05179057
Last Updated: 2024-05-08
Results Overview
Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower limit of quantification (LLOQ).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
57 participants
Primary outcome timeframe
Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion)
Results posted on
2024-05-08
Participant Flow
Participants were enrolled at 47 study centers in the United States, Canada, Italy, Spain, Sweden, and the United Kingdom, and participated from April 2022 to January 2024.
Participants with adenovirus infection receiving standard of care following allogeneic hematopoietic stem cell transplant (allo-HCT) were randomized in a 1:1 ratio to receive either posoleucel or placebo. Randomization was stratified by level of viremia (≥10,000 copies/mL or \<10,000 copies/mL adenovirus DNA) and age (≥12 years or \<12 years).
Participant milestones
| Measure |
Posoleucel, Then Placebo
Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
Placebo, Then Posoleucel
Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
|
Overall Study
Received Primary Study Treatment
|
28
|
23
|
|
Overall Study
Met Cross-over Eligibility Criteria
|
4
|
5
|
|
Overall Study
Received Cross-over Treatment
|
4
|
5
|
|
Overall Study
COMPLETED
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
20
|
14
|
Reasons for withdrawal
| Measure |
Posoleucel, Then Placebo
Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
Placebo, Then Posoleucel
Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Non-compliance with protocol requirements or study-related procedures
|
1
|
0
|
|
Overall Study
Study terminated
|
13
|
7
|
|
Overall Study
Discontinuation or withdrawal by participants/parent/legal guardian
|
2
|
2
|
|
Overall Study
Never received primary or cross-over study treatment
|
1
|
3
|
Baseline Characteristics
Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Baseline characteristics by cohort
| Measure |
Posoleucel, Then Placebo
n=30 Participants
Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
Placebo, Then Posoleucel
n=27 Participants
Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.2 years
STANDARD_DEVIATION 17.10 • n=39 Participants
|
14.9 years
STANDARD_DEVIATION 15.80 • n=41 Participants
|
15.6 years
STANDARD_DEVIATION 16.36 • n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion)Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of posoleucel or placebo. Only participants in the mITT population who completed through Day 29 or discontinued early were included.
Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower limit of quantification (LLOQ).
Outcome measures
| Measure |
Posoleucel, Then Placebo
n=25 Participants
Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
Placebo, Then Posoleucel
n=21 Participants
Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
Posoleucel (Cross-over Period)
Participants were randomized to receive 2 sequential infusions of placebo in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received posoleucel during the Cross-over Period.
|
Placebo (Cross-over Period)
Participants were randomized to receive 2 sequential infusions of posoleucel in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received placebo during the Cross-over Period.
|
|---|---|---|---|---|
|
Number of Participants With Undetectable Adenovirus Infection
|
11 Participants
|
9 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 34 weeksPopulation: The safety population included all participants who received any amount of posoleucel or placebo and had at least one post-treatment safety assessment.
A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included acute or chronic graft versus host disease, cytokine release syndrome, infusion-related reactions, and graft failure or rejection. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
Outcome measures
| Measure |
Posoleucel, Then Placebo
n=28 Participants
Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
Placebo, Then Posoleucel
n=23 Participants
Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
Eligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.
|
Posoleucel (Cross-over Period)
n=5 Participants
Participants were randomized to receive 2 sequential infusions of placebo in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received posoleucel during the Cross-over Period.
|
Placebo (Cross-over Period)
n=4 Participants
Participants were randomized to receive 2 sequential infusions of posoleucel in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received placebo during the Cross-over Period.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Any TEAE leading to study discontinuation
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
27 Participants
|
23 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Any TEAE related to study treatment
|
7 Participants
|
9 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Any AESI
|
6 Participants
|
9 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Any SAE
|
16 Participants
|
16 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Any SAE related to study treatment
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Any TEAE leading to study treatment discontinuation
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Any TEAE leading to death
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 29 up to Week 10Population: Data not collected due to early termination after Data and Safety Monitoring Board (DSMB) futility analysis concluded the study was unlikely to meet its primary endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and Day 29Population: Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29Population: Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose to 34 weeksPopulation: Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 34 weeksPopulation: Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.
Outcome measures
Outcome data not reported
Adverse Events
Posoleucel (Primary Study Period)
Serious events: 16 serious events
Other events: 27 other events
Deaths: 2 deaths
Placebo (Primary Study Period)
Serious events: 16 serious events
Other events: 23 other events
Deaths: 1 deaths
Posoleucel (Cross-over Period)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Cross-over Period)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Posoleucel (Primary Study Period)
n=28 participants at risk
Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days, during the Primary Study Period.
|
Placebo (Primary Study Period)
n=23 participants at risk
Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days, during the Primary Study Period.
|
Posoleucel (Cross-over Period)
n=5 participants at risk
Participants were randomized to receive 2 sequential infusions of placebo in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received posoleucel during the Cross-over Period.
|
Placebo (Cross-over Period)
n=4 participants at risk
Participants were randomized to receive 2 sequential infusions of posoleucel in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received placebo during the Cross-over Period.
|
|---|---|---|---|---|
|
Infections and infestations
Cryptosporidiosis infection
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Candida infection
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Pneumonia
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
COVID-19
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Gastroenteritis
|
3.6%
1/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Device related infection
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Gastroenteritis rotavirus
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Localised infection
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Pancreatitis viral
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Parainfluenzae virus infection
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Parotitis
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Pneumococcal bacteraemia
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
General disorders
Pyrexia
|
14.3%
4/28 • Up to 34 weeks
|
13.0%
3/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
General disorders
Asthenia
|
3.6%
1/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
General disorders
Disease progression
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
General disorders
Influenza like illness
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Chronic graft versus host disease in intestine
|
3.6%
1/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Acute graft versus host disease in skin
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Chronic graft versus host disease
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Chronic graft versus host disease in lung
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Chronic graft versus host disease oral
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
3.6%
1/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Blood and lymphatic system disorders
Immune-mediated cytopenia
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Renal and urinary disorders
Renal tubular disorder
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Vascular disorders
Capillary leak syndrome
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Hepatobiliary disorders
Acute hepatic failure
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Weight decreased
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Nervous system disorders
Seizure
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
Other adverse events
| Measure |
Posoleucel (Primary Study Period)
n=28 participants at risk
Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days, during the Primary Study Period.
|
Placebo (Primary Study Period)
n=23 participants at risk
Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days, during the Primary Study Period.
|
Posoleucel (Cross-over Period)
n=5 participants at risk
Participants were randomized to receive 2 sequential infusions of placebo in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received posoleucel during the Cross-over Period.
|
Placebo (Cross-over Period)
n=4 participants at risk
Participants were randomized to receive 2 sequential infusions of posoleucel in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received placebo during the Cross-over Period.
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
10.7%
3/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Infections and infestations
Rhinovirus infection
|
7.1%
2/28 • Up to 34 weeks
|
13.0%
3/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
BK virus infection
|
10.7%
3/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Candida infection
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Pneumonia
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Adenovirus infection
|
10.7%
3/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/28 • Up to 34 weeks
|
13.0%
3/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Cytomegalovirus viraemia
|
10.7%
3/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Gastroenteritis adenovirus
|
3.6%
1/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Sepsis
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
3/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Adenoviral hepatitis
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Bacteraemia
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Enterovirus infection
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
3.6%
1/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Infections and infestations
Klebsiella bacteraemia
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Epstein-Barr viraemia
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Klebsiella infection
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
8/28 • Up to 34 weeks
|
17.4%
4/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
17.9%
5/28 • Up to 34 weeks
|
17.4%
4/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
21.4%
6/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Nausea
|
21.4%
6/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.7%
3/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Ascites
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/28 • Up to 34 weeks
|
13.0%
3/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Platelet count decreased
|
7.1%
2/28 • Up to 34 weeks
|
13.0%
3/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Weight decreased
|
7.1%
2/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
2/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Blood bicarbonate decreased
|
3.6%
1/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Investigations
Blood bilirubin increased
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Blood creatinine increased
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.6%
1/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Neutrophil count decreased
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Lipase increased
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Investigations
Enterobacter test positive
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
32.1%
9/28 • Up to 34 weeks
|
26.1%
6/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
17.9%
5/28 • Up to 34 weeks
|
13.0%
3/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.7%
3/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
2/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
1/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Iron overload
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
General disorders
Pyrexia
|
35.7%
10/28 • Up to 34 weeks
|
34.8%
8/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
General disorders
Gait disturbance
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
General disorders
Asthenia
|
3.6%
1/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
21.4%
6/28 • Up to 34 weeks
|
21.7%
5/23 • Up to 34 weeks
|
40.0%
2/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.7%
3/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.7%
3/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.7%
3/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
3/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
2/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.7%
3/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
3.6%
1/28 • Up to 34 weeks
|
13.0%
3/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Cytokine release syndrome
|
3.6%
1/28 • Up to 34 weeks
|
13.0%
3/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Acute graft versus host disease in skin
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Hypogammaglobulinaemia
|
10.7%
3/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Immune system disorders
Graft versus host disease in liver
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Renal and urinary disorders
Dysuria
|
7.1%
2/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Renal and urinary disorders
Proteinuria
|
10.7%
3/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
7.1%
2/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Cardiac disorders
Pericardial effusion
|
7.1%
2/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Vascular disorders
Hypertension
|
14.3%
4/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Congenital, familial and genetic disorders
Phimosis
|
14.3%
4/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Eye disorders
Orbital haematoma
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/28 • Up to 34 weeks
|
8.7%
2/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
0.00%
0/5 • Up to 34 weeks
|
25.0%
1/4 • Up to 34 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Up to 34 weeks
|
4.3%
1/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.6%
1/28 • Up to 34 weeks
|
0.00%
0/23 • Up to 34 weeks
|
20.0%
1/5 • Up to 34 weeks
|
0.00%
0/4 • Up to 34 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place