Trial Outcomes & Findings for Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant (NCT NCT02506933)
NCT ID: NCT02506933
Last Updated: 2025-08-22
Results Overview
Cytomegalovirus (CMV) events included CMV reactivation ≥1250 CMV DNA IU/mL, CMV viremia prompting antiviral therapy, or CMV disease before day 100 after HCT.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Prior to day 100 post-HCT
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Arm I (Multi-peptide CMV-MVA Vaccine)
Patients receive multi-peptide CMV-MVA vaccine IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Placebo)
Patients receive placebo IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given IM
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant
Baseline characteristics by cohort
| Measure |
Arm I (Multi-peptide CMV-MVA Vaccine)
n=51 Participants
Patients receive multi-peptide CMV-MVA vaccine IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Placebo)
n=51 Participants
Patients receive placebo IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given IM
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
57 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
51 participants
n=7 Participants
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prior to day 100 post-HCTCytomegalovirus (CMV) events included CMV reactivation ≥1250 CMV DNA IU/mL, CMV viremia prompting antiviral therapy, or CMV disease before day 100 after HCT.
Outcome measures
| Measure |
Arm I (Multi-peptide CMV-MVA Vaccine)
n=51 Participants
Patients receive multi-peptide CMV-MVA vaccine IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Placebo)
n=51 Participants
Patients receive placebo IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given IM
|
|---|---|---|
|
Cytomegalovirus (CMV) Events to Day 100
|
5 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to 100 days post-transplantSevere acute graft-versus-host disease (aGVHD, grade 3-4) was monitored as every 12th subject on the vaccine arm reaches the 100 day evaluation point. aGVHD was scored using Keystone consensus criteria \[Przepiorka, D., et al., 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant, 1995. 15(6): p. 825-8\].
Outcome measures
| Measure |
Arm I (Multi-peptide CMV-MVA Vaccine)
n=51 Participants
Patients receive multi-peptide CMV-MVA vaccine IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Placebo)
n=51 Participants
Patients receive placebo IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given IM
|
|---|---|---|
|
Incidence of Severe (Grade 3-4) Acute Graft-Versus-Host Disease
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year post-HCTDeath due to any cause.
Outcome measures
| Measure |
Arm I (Multi-peptide CMV-MVA Vaccine)
n=51 Participants
Patients receive multi-peptide CMV-MVA vaccine IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Placebo)
n=51 Participants
Patients receive placebo IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given IM
|
|---|---|---|
|
All-cause Mortality
|
8 Participants
|
8 Participants
|
Adverse Events
Arm I (Multi-peptide CMV-MVA Vaccine)
Serious events: 15 serious events
Other events: 50 other events
Deaths: 8 deaths
Arm II (Placebo)
Serious events: 14 serious events
Other events: 51 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm I (Multi-peptide CMV-MVA Vaccine)
n=51 participants at risk
Patients receive multi-peptide CMV-MVA vaccine IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Placebo)
n=51 participants at risk
Patients receive placebo IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given IM
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
9.8%
5/51 • Number of events 9 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Chills
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Edema trunk
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Fever
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
9.8%
5/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Injection site reaction
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Bladder infection
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Lung infection
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Septic shock
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Upper respiratory infection
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
bacteremia
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
pneumonia
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
Headache
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
Confusion
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Left lower lobe Pneumonia
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Periorbital cellulitis
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
1/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
Other adverse events
| Measure |
Arm I (Multi-peptide CMV-MVA Vaccine)
n=51 participants at risk
Patients receive multi-peptide CMV-MVA vaccine IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Placebo)
n=51 participants at risk
Patients receive placebo IM on days 28 and 56 post-HCT.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given IM
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
76.5%
39/51 • Number of events 137 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
72.5%
37/51 • Number of events 125 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Cardiac disorders
Sinus tachycardia
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Cardiac disorders
increased cardiac panel
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Eye disorders
Blurred vision
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Eye disorders
Double vision
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Eye disorders
Dry eye
|
7.8%
4/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Eye disorders
Eye pain
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Eye disorders
Xanthopsia
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Eye disorders
Yellow tint to vision
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Eye disorders
itching eyes
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.5%
13/51 • Number of events 21 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
19.6%
10/51 • Number of events 18 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Bloating
|
5.9%
3/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Constipation
|
3.9%
2/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
7.8%
4/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
17/51 • Number of events 27 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
25.5%
13/51 • Number of events 21 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Dry mouth
|
7.8%
4/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Early Satiety
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Herpatic lesion on tongue
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Lower lip lesion
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Mouth sore
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Nausea
|
29.4%
15/51 • Number of events 28 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
31.4%
16/51 • Number of events 38 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Oral pain
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Stomach pain
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Tenesmus
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
9/51 • Number of events 11 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
17.6%
9/51 • Number of events 13 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
bloating
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
burnt tongue sensation
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
indigestion
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
lip lesions
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
mouth lesions
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
mouth sensitivity
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
mouth sores and ulcers
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
mouth sores/ulcers
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
tenesmus
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Chills
|
7.8%
4/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
9.8%
5/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Clogged ear
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Edema face
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Edema limbs
|
9.8%
5/51 • Number of events 9 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
19.6%
10/51 • Number of events 11 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Fatigue
|
45.1%
23/51 • Number of events 49 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
43.1%
22/51 • Number of events 38 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Fever
|
23.5%
12/51 • Number of events 14 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
9.8%
5/51 • Number of events 7 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Flu like symptoms
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Fluid overload
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Gait disturbance
|
3.9%
2/51 • Number of events 8 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Injection site reaction
|
41.2%
21/51 • Number of events 30 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Malaise
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Multi-organ failure
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Non-cardiac chest pain
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Otitis media
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Pain
|
11.8%
6/51 • Number of events 11 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
5.9%
3/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Pain in left rib area
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Runny nose
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
body aches
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
foot pain
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
pain at injection site
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
temporal ache
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Bronchial infection
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Diff
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Mucosal infection
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Paronycia
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Rhinovirus
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Sepsis
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Skin infection
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
coagulase negative Staph bacteremia
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
diff
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Injury, poisoning and procedural complications
Fall
|
11.8%
6/51 • Number of events 11 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Alanine aminotransferase increased
|
51.0%
26/51 • Number of events 79 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
56.9%
29/51 • Number of events 81 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Alkaline phosphatase increased
|
35.3%
18/51 • Number of events 44 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
43.1%
22/51 • Number of events 49 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Aspartate aminotransferase increased
|
49.0%
25/51 • Number of events 66 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
51.0%
26/51 • Number of events 66 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Blood bilirubin increased
|
17.6%
9/51 • Number of events 23 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
15.7%
8/51 • Number of events 12 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Cholesterol high
|
39.2%
20/51 • Number of events 39 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
27.5%
14/51 • Number of events 34 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Creatinine increased
|
17.6%
9/51 • Number of events 13 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
21.6%
11/51 • Number of events 16 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
INR increased
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Lymphocyte count decreased
|
47.1%
24/51 • Number of events 98 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
39.2%
20/51 • Number of events 77 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Neutrophil count decreased
|
41.2%
21/51 • Number of events 71 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
37.3%
19/51 • Number of events 46 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Platelet count decreased
|
64.7%
33/51 • Number of events 112 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
72.5%
37/51 • Number of events 108 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Weight loss
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
White blood cell decreased
|
68.6%
35/51 • Number of events 114 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
60.8%
31/51 • Number of events 79 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Anorexia
|
17.6%
9/51 • Number of events 18 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
29.4%
15/51 • Number of events 29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
64.7%
33/51 • Number of events 88 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
68.6%
35/51 • Number of events 91 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.7%
8/51 • Number of events 10 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
9.8%
5/51 • Number of events 7 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
37.3%
19/51 • Number of events 44 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
47.1%
24/51 • Number of events 45 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.0%
1/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
7.8%
4/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.3%
19/51 • Number of events 38 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
27.5%
14/51 • Number of events 25 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.9%
2/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
13.7%
7/51 • Number of events 10 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.8%
4/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.6%
10/51 • Number of events 21 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
27.5%
14/51 • Number of events 38 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
52.9%
27/51 • Number of events 46 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
54.9%
28/51 • Number of events 56 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
39.2%
20/51 • Number of events 56 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
62.7%
32/51 • Number of events 74 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.7%
8/51 • Number of events 13 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
21.6%
11/51 • Number of events 23 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
3/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
7.8%
4/51 • Number of events 8 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.7%
7/51 • Number of events 7 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
5.9%
3/51 • Number of events 6 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Steroid myopathy
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Musculoskeletal and connective tissue disorders
muscle cramps
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
Dizziness
|
13.7%
7/51 • Number of events 15 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 6 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
Dysgeusia
|
5.9%
3/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
Headache
|
9.8%
5/51 • Number of events 6 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
17.6%
9/51 • Number of events 9 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
Migraine
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.8%
5/51 • Number of events 9 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
Tremor
|
5.9%
3/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
7.8%
4/51 • Number of events 7 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
lightheadedness
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
numbness in fingers
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
Anxiety
|
5.9%
3/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
Confusion
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
Depression
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
Insomnia
|
11.8%
6/51 • Number of events 10 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
PTSD
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Renal and urinary disorders
Dysuria
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Renal and urinary disorders
Proteinuria
|
11.8%
6/51 • Number of events 8 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
7.8%
4/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Renal and urinary disorders
Urinary frequency
|
7.8%
4/51 • Number of events 6 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Renal and urinary disorders
Vaginal spotting
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Reproductive system and breast disorders
genital sore
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
6/51 • Number of events 10 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
11.8%
6/51 • Number of events 6 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.9%
2/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
7.8%
4/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
7.8%
4/51 • Number of events 5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.9%
2/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
9.8%
5/51 • Number of events 10 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
7.8%
4/51 • Number of events 6 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
2.0%
1/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Folliculitis lesions
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Nodule on ear
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.7%
7/51 • Number of events 14 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
17.6%
9/51 • Number of events 13 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 4 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.6%
10/51 • Number of events 16 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
33.3%
17/51 • Number of events 36 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Skin hypersensitivity
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
Small bump on left side of jaw
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
folliculitis
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
left axillary skin lesions
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
redness on lower eyelid
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.9%
2/51 • Number of events 2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Skin and subcutaneous tissue disorders
skin nodule on ear
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Surgical and medical procedures
Pain at bone marrow biopsy site
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Vascular disorders
Hematoma
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Vascular disorders
Hot flashes
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Vascular disorders
Hypertension
|
51.0%
26/51 • Number of events 101 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
47.1%
24/51 • Number of events 92 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Vascular disorders
Hypotension
|
9.8%
5/51 • Number of events 6 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
5.9%
3/51 • Number of events 3 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Vascular disorders
Thrombotic Microangiopathy
|
2.0%
1/51 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
0.00%
0/51 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place