Trial Outcomes & Findings for CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML (NCT NCT04620681)
NCT ID: NCT04620681
Last Updated: 2025-11-04
Results Overview
Maximum Tolerated Dose will be determined by testing increasing doses of CD8 depleted non-engrafting HLA-mismatched unrelated donor lymphocytes infusion (NE-DLI).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 60 days per dose level
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
Phase 1 Dose Level 1
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 1: 1X10\^6 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 1 Dose Level 2
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 2: 1X10\^7 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 1 Dose Level 3
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 3: 5 X10\^7 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 2 -Treatment at Maximum Tolerated Dose (MTD)
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at MTD.
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
10
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Level 1
n=3 Participants
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 1: 1X10\^6 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 1 Dose Level 2
n=3 Participants
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 2: 1X10\^7 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 1 Dose Level 3
n=3 Participants
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 3: 5 X10\^7 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 2 -Treatment at Maximum Tolerated Dose (MTD)
n=10 Participants
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at MTD.
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
4 Participants
n=3 Participants
|
7 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
6 Participants
n=3 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
5 Participants
n=3 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
5 Participants
n=3 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
10 Participants
n=3 Participants
|
17 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
10 Participants
n=3 Participants
|
18 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=15 Participants
|
3 participants
n=161 Participants
|
3 participants
n=100 Participants
|
10 participants
n=3 Participants
|
19 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 60 days per dose levelMaximum Tolerated Dose will be determined by testing increasing doses of CD8 depleted non-engrafting HLA-mismatched unrelated donor lymphocytes infusion (NE-DLI).
Outcome measures
| Measure |
Maximum Tolerated Dose (MTD)
n=9 Participants
All participants from dose escalation phase who received treatment at either dose level 1, dose level 2, or dose level 3.
|
Participants Treated at MTD - MDS
Participants Treated at MTD - MDS
|
|---|---|---|
|
Maximum Tolerated Dose of CD8 Depleted Non-engrafting HLA-mismatched Unrelated Donor Lymphocytes Infusion (NE-DLI)
|
5 10^7 CD4 cells/kg
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: As specified in the protocol, only participants treated at the MTD are included in this outcome measure.
Overall Response Rate is defined as Complete Response + Partial Response using RECIST v1.1 criteria.
Outcome measures
| Measure |
Maximum Tolerated Dose (MTD)
n=13 Participants
All participants from dose escalation phase who received treatment at either dose level 1, dose level 2, or dose level 3.
|
Participants Treated at MTD - MDS
Participants Treated at MTD - MDS
|
|---|---|---|
|
Overall Response Rate
|
61.5 percentage of Participants with Response
Interval 31.6 to 86.1
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: As specified in the protocol, only participants treated at the MTD are included in this outcome measure.
Progression Free Survival is defined as the time from enrollment to date of progression or death, or censor at last follow-up date.
Outcome measures
| Measure |
Maximum Tolerated Dose (MTD)
n=13 Participants
All participants from dose escalation phase who received treatment at either dose level 1, dose level 2, or dose level 3.
|
Participants Treated at MTD - MDS
Participants Treated at MTD - MDS
|
|---|---|---|
|
Progression Free Survival
|
8.7 Months
Interval 1.4 to
Not reached
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: As specified in the protocol, only participants treated at the MTD are included in this outcome measure.
Overall Survival is defined as the time from study enrollment to death from any cause or censored at last follow up date
Outcome measures
| Measure |
Maximum Tolerated Dose (MTD)
n=13 Participants
All participants from dose escalation phase who received treatment at either dose level 1, dose level 2, or dose level 3.
|
Participants Treated at MTD - MDS
Participants Treated at MTD - MDS
|
|---|---|---|
|
Overall Survival
|
11.9 Months
Interval 2.5 to
Not Reached
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: As specified in the protocol, only participants treated at the MTD are included in this outcome measure.
Hematologic response will be determined using International Working Group 2006 criteria for MDS patients and the International Working Group 2003 criteria for AML
Outcome measures
| Measure |
Maximum Tolerated Dose (MTD)
n=11 Participants
All participants from dose escalation phase who received treatment at either dose level 1, dose level 2, or dose level 3.
|
Participants Treated at MTD - MDS
n=2 Participants
Participants Treated at MTD - MDS
|
|---|---|---|
|
Hematologic Response
|
7 Number of Participants achieving CR
|
0 Number of Participants achieving CR
|
Adverse Events
Phase 1 Dose Level 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1 Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1 Dose Level 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 2 -Treatment at Maximum Tolerated Dose (MTD)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Phase 1 Dose Level 1
n=3 participants at risk
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 1: 1X10\^6 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 1 Dose Level 2
n=3 participants at risk
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 2: 1X10\^7 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 1 Dose Level 3
n=3 participants at risk
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 3: 5 X10\^7 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 2 -Treatment at Maximum Tolerated Dose (MTD)
n=10 participants at risk
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at MTD.
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
|---|---|---|---|---|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Infections and infestations
Skin Infection
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
Other adverse events
| Measure |
Phase 1 Dose Level 1
n=3 participants at risk
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 1: 1X10\^6 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 1 Dose Level 2
n=3 participants at risk
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 2: 1X10\^7 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 1 Dose Level 3
n=3 participants at risk
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at dose level 3: 5 X10\^7 CD4 T Cells/kg
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
Phase 2 -Treatment at Maximum Tolerated Dose (MTD)
n=10 participants at risk
All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at MTD.
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes: Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
Standard of Care Chemotherapy: Standard of care cytarabine-based chemotherapy
|
|---|---|---|---|---|
|
Infections and infestations
Endocarditis infective
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
66.7%
2/3 • Number of events 2 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Infections and infestations
Sepsis
|
66.7%
2/3 • Number of events 2 • 1 Year
|
100.0%
3/3 • Number of events 3 • 1 Year
|
66.7%
2/3 • Number of events 2 • 1 Year
|
40.0%
4/10 • Number of events 5 • 1 Year
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
20.0%
2/10 • Number of events 2 • 1 Year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
30.0%
3/10 • Number of events 4 • 1 Year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
10.0%
1/10 • Number of events 2 • 1 Year
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 4 • 1 Year
|
33.3%
1/3 • Number of events 3 • 1 Year
|
33.3%
1/3 • Number of events 2 • 1 Year
|
20.0%
2/10 • Number of events 9 • 1 Year
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Number of events 4 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
10.0%
1/10 • Number of events 2 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 6 • 1 Year
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
66.7%
2/3 • Number of events 2 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 2 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
20.0%
2/10 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 2 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/3 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 5 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 1 Year
|
0.00%
0/3 • 1 Year
|
33.3%
1/3 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place