Trial Outcomes & Findings for RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation (NCT NCT04014790)
NCT ID: NCT04014790
Last Updated: 2024-05-28
Results Overview
Acute GVHD will be graded and assessed according to modified KEYSTONE criteria and the severity grade (Grade II through IV) were captured up through the first 100 days post-transplant
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Day 100 post-transplant
Results posted on
2024-05-28
Participant Flow
Participant milestones
| Measure |
RGI-2001
Subjects will be administered RGI 2001 in combination with standard of care treatment
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
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Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
RGI-2001
Subjects will be administered RGI 2001 in combination with standard of care treatment
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
RGI-2001
n=49 Participants
Subjects will be administered RGI 2001 in combination with standard of care treatment
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 11.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 100 post-transplantPopulation: intent to treat population
Acute GVHD will be graded and assessed according to modified KEYSTONE criteria and the severity grade (Grade II through IV) were captured up through the first 100 days post-transplant
Outcome measures
| Measure |
RGI-2001
n=48 Participants
Subjects will be administered RGI 2001 in combination with standard of care treatment
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
Grades II-IV aGVHD
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 180 post-transplantPopulation: Intent to treat
Acute GVHD will be graded and assessed within 180 days post-transplant
Outcome measures
| Measure |
RGI-2001
n=48 Participants
Subjects will be administered RGI 2001 in combination with standard of care treatment
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
Grades II-IV aGVHD
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 year post-transplantPopulation: intent to treat
The probability of mortality not preceded by relapse of the underlying malignancy will be estimated
Outcome measures
| Measure |
RGI-2001
n=48 Participants
Subjects will be administered RGI 2001 in combination with standard of care treatment
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
Non-relapse Mortality (NRM) Rates
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 year post-transplantPopulation: Intent to treat
The probability of survival without relapse of the underlying malignancy will be estimated
Outcome measures
| Measure |
RGI-2001
n=48 Participants
Subjects will be administered RGI 2001 in combination with standard of care treatment
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
Disease-free Survival (DFS)
|
40 Participants
|
SECONDARY outcome
Timeframe: 1 year post-transplantPopulation: intent to treat
The probability of survival without relapse of the underlying malignancy, without severe (grades 3-4) acute GVHD, and without chronic GVHD requiring systemic immunosuppression will be estimated
Outcome measures
| Measure |
RGI-2001
n=48 Participants
Subjects will be administered RGI 2001 in combination with standard of care treatment
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
GvHD-free, Relapse Free Survival (GRFS)
|
26 Participants
|
SECONDARY outcome
Timeframe: 1 year post-transplantPopulation: intent to treat
The probability of survival will be estimated
Outcome measures
| Measure |
RGI-2001
n=48 Participants
Subjects will be administered RGI 2001 in combination with standard of care treatment
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
Overall Survival (OS)
|
44 Participants
|
Adverse Events
RGI-2001
Serious events: 8 serious events
Other events: 49 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
RGI-2001
n=49 participants at risk
Subjects will be administered RGI 2001 in combination with standard of care treatment (Tacrolimus and Methotrexate)
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
Cardiac disorders
Myocarditis
|
2.0%
1/49 • Number of events 1 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/49 • Number of events 1 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Infections and infestations
Septic Shock
|
2.0%
1/49 • Number of events 1 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 1 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.0%
1/49 • Number of events 1 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary veno-occlusive disease
|
2.0%
1/49 • Number of events 1 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.0%
1/49 • Number of events 1 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.0%
1/49 • Number of events 1 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
Other adverse events
| Measure |
RGI-2001
n=49 participants at risk
Subjects will be administered RGI 2001 in combination with standard of care treatment (Tacrolimus and Methotrexate)
RGI-2001: Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Standard of Care: Standard of care prophylaxis regimen will be administered according to institutional guidelines
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.2%
6/49 • Number of events 6 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
7/49 • Number of events 7 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Gastrointestinal disorders
Constipation
|
6.1%
3/49 • Number of events 3 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
18.4%
9/49 • Number of events 9 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Gastrointestinal disorders
Nausea
|
22.4%
11/49 • Number of events 11 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Gastrointestinal disorders
Stomatitis
|
18.4%
9/49 • Number of events 9 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Gastrointestinal disorders
Vomiting
|
18.4%
9/49 • Number of events 9 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
General disorders
Fatigue
|
14.3%
7/49 • Number of events 7 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
General disorders
Muscosal Inflammation
|
12.2%
6/49 • Number of events 6 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Investigations
Alanine Aminotransferase increased
|
12.2%
6/49 • Number of events 6 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Investigations
Aspartate Aminotransferase increased
|
6.1%
3/49 • Number of events 3 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
6.1%
3/49 • Number of events 3 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Investigations
Blood Creatinine increased
|
6.1%
3/49 • Number of events 3 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Investigations
Blood Lactate Dehyrogenase increased
|
6.1%
3/49 • Number of events 3 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Investigations
Neutrophil Count Decreased
|
12.2%
6/49 • Number of events 6 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Investigations
Platelet Count Decreased
|
14.3%
7/49 • Number of events 7 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Investigations
White blood cell count decreased
|
12.2%
6/49 • Number of events 6 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
18.4%
9/49 • Number of events 9 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.2%
4/49 • Number of events 4 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.1%
3/49 • Number of events 3 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.2%
6/49 • Number of events 6 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.2%
4/49 • Number of events 4 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.1%
3/49 • Number of events 3 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Nervous system disorders
Dizziness
|
8.2%
4/49 • Number of events 4 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Nervous system disorders
Dysgeusia
|
10.2%
5/49 • Number of events 5 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Nervous system disorders
Headache
|
8.2%
4/49 • Number of events 4 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Nervous system disorders
Tremor
|
6.1%
3/49 • Number of events 3 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.2%
6/49 • Number of events 6 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.2%
4/49 • Number of events 4 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
8.2%
4/49 • Number of events 4 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.4%
10/49 • Number of events 10 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
|
Vascular disorders
Hypertension
|
6.1%
3/49 • Number of events 3 • TEAE is defined as any AE reported on or after the first dose date of RGI-2001, or that was already present and worsened after the first dose date, up to 30 days after the last RGI-2001 dose date. TEAE were collected from sign of consent up through 9 weeks after transplant. TEAE for all cause mortality were collected up through 1 year.
TEAE were collected from sign of consent up through 9 weeks after transplant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place