Trial Outcomes & Findings for Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (NCT NCT02396134)
NCT ID: NCT02396134
Last Updated: 2025-03-03
Results Overview
The primary endpoint was CMV event. A CMV event encompasses detection of CMV by either qPCR (termed "reactivation": DNAemia at ≥500 gc/ml = 1250iu/ml) or by tissue histology (end-organ disease). The cumulative incidence was calculated as competing risks using the method of Gooley with death viewed as a competing risk.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Up to day 100 after HCT
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
Arm I (CMVpp65-A*0201 Peptide Vaccine)
Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT.
CMVpp65-A\*0201 peptide vaccine: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
Patients receive placebo SC on days 28 and 56 after HCT.
Placebo: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
|
Overall Study
COMPLETED
|
32
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Arm I (CMVpp65-A*0201 Peptide Vaccine)
n=32 Participants
Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT.
CMVpp65-A\*0201 peptide vaccine: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=29 Participants
Patients receive placebo SC on days 28 and 56 after HCT.
Placebo: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
64 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-disclosed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to day 100 after HCTThe primary endpoint was CMV event. A CMV event encompasses detection of CMV by either qPCR (termed "reactivation": DNAemia at ≥500 gc/ml = 1250iu/ml) or by tissue histology (end-organ disease). The cumulative incidence was calculated as competing risks using the method of Gooley with death viewed as a competing risk.
Outcome measures
| Measure |
Arm I (CMVpp65-A*0201 Peptide Vaccine)
n=32 Participants
Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT.
CMVpp65-A\*0201 peptide vaccine: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=29 Participants
Patients receive placebo SC on days 28 and 56 after HCT.
Placebo: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Cumulative Incidence of CMV at 100 Days
|
25.1 cases per 100 persons
Interval 11.6 to 41.2
|
13.8 cases per 100 persons
Interval 4.2 to 28.9
|
SECONDARY outcome
Timeframe: Up to 100 days after transplantNRM was defined as death without recurrent or progressive disease after transplant. Probabilities of NRM were calculated as competing risks using the method of Gooley with relapse viewed as a competing risk.
Outcome measures
| Measure |
Arm I (CMVpp65-A*0201 Peptide Vaccine)
n=32 Participants
Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT.
CMVpp65-A\*0201 peptide vaccine: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=29 Participants
Patients receive placebo SC on days 28 and 56 after HCT.
Placebo: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Non-Relapse Mortality (NRM) at 100 Days
|
3.1 cases per 100 persons
Interval 0.2 to 14.0
|
3.4 cases per 100 persons
Interval 0.2 to 15.3
|
SECONDARY outcome
Timeframe: Up to 365 days after HCTProbabilities of relapse were calculated as competing risks using the method of Gooley with death viewed as a competing risk.
Outcome measures
| Measure |
Arm I (CMVpp65-A*0201 Peptide Vaccine)
n=32 Participants
Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT.
CMVpp65-A\*0201 peptide vaccine: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=29 Participants
Patients receive placebo SC on days 28 and 56 after HCT.
Placebo: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Cumulative Incidence of Relapse at One Year
|
12.5 cases per 100 persons
Interval 3.9 to 26.5
|
25.7 cases per 100 persons
Interval 11.1 to 43.3
|
Adverse Events
Arm I (CMVpp65-A*0201 Peptide Vaccine)
Serious events: 10 serious events
Other events: 28 other events
Deaths: 8 deaths
Arm II (Placebo)
Serious events: 7 serious events
Other events: 26 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm I (CMVpp65-A*0201 Peptide Vaccine)
n=32 participants at risk
Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT.
CMVpp65-A\*0201 peptide vaccine: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=29 participants at risk
Patients receive placebo SC on days 28 and 56 after HCT.
Placebo: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
3.1%
1/32 • 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%
0/29 • 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
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Colitis
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Vomiting
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Fever
|
9.4%
3/32 • 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.
|
6.9%
2/29 • 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
Hospitalization for worsening GVHD symptoms
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
CMV viremia
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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.
|
3.4%
1/29 • 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
negative rod bacteremia
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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%
0/29 • 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
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Electrolyte derangements
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Hyperglycemia
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
syncope
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Cystitis noninfective
|
3.1%
1/32 • 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%
0/29 • 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
Hemorrhagic cystitis
|
3.1%
1/32 • 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%
0/29 • 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
parainfluenza
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Worsening skin GVHD
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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 (CMVpp65-A*0201 Peptide Vaccine)
n=32 participants at risk
Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT.
CMVpp65-A\*0201 peptide vaccine: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Placebo)
n=29 participants at risk
Patients receive placebo SC on days 28 and 56 after HCT.
Placebo: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
65.6%
21/32 • 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.
|
75.9%
22/29 • Number of events 94 • 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
Disseminated intravascular coagulation
|
3.1%
1/32 • 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%
0/29 • 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
Leukocytosis
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Thrombotic thrombocytopenic purpura
|
6.2%
2/32 • 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%
0/29 • 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
progression to AML
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
thrombocytopenia
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Cardiac disorders
Myocardial infarction
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Cardiac disorders
Sinus bradycardia
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Cardiac disorders
heart palpitations
|
3.1%
1/32 • 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%
0/29 • 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
Tinnitus
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Eye disorders
Conjunctivitis
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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.
|
6.9%
2/29 • 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.
|
|
Eye disorders
Eye irritation
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Eye pain
|
3.1%
1/32 • 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%
0/29 • 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
|
25.0%
8/32 • 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.
|
20.7%
6/29 • 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.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Bloating
|
3.1%
1/32 • 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.
|
6.9%
2/29 • 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.
|
|
Gastrointestinal disorders
CMV gastritis
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
|
6.2%
2/32 • 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.
|
3.4%
1/29 • 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
|
46.9%
15/32 • 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.
|
41.4%
12/29 • 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
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
6.9%
2/29 • 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
Gastric hemorrhage
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
2/32 • 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%
0/29 • 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
|
9.4%
3/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Ileus
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Gastrointestinal disorders
Mouth lesion
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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 lesion/sore
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
|
3.1%
1/32 • 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.
|
3.4%
1/29 • 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
|
50.0%
16/32 • Number of events 33 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
37.9%
11/29 • 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.
|
|
Gastrointestinal disorders
Oral pain
|
3.1%
1/32 • 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.
|
13.8%
4/29 • 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.
|
|
Gastrointestinal disorders
Pearly Papule on oral mucosa
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Rectal pain
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
|
3.1%
1/32 • 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.
|
6.9%
2/29 • 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
|
25.0%
8/32 • 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.
|
17.2%
5/29 • 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
mouth pain
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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 sores
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
umbilcal hernia
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Bleeding from hemorrhoids
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Chills
|
12.5%
4/32 • 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.
|
3.4%
1/29 • 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
Difficulty tasting food
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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 face
|
3.1%
1/32 • 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%
0/29 • 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
|
12.5%
4/32 • 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.
|
17.2%
5/29 • 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.
|
|
General disorders
Fatigue
|
43.8%
14/32 • Number of events 26 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
51.7%
15/29 • 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.
|
|
General disorders
Fever
|
21.9%
7/32 • 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.
|
10.3%
3/29 • 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
|
6.2%
2/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Localized edema
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Malaise
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
Pain
|
6.2%
2/32 • 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.
|
3.4%
1/29 • 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
lightheadedness
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
General disorders
soft tissue edema
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
hyperbilirubinemia
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
BK virus
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
C. Diff. infection
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
C. diff.
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
CMV viremia
|
3.1%
1/32 • 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.
|
3.4%
1/29 • 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
Lower respiratory tract infection
|
3.1%
1/32 • 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%
0/29 • 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
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Sinusitis
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
Thrush
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Infections and infestations
serratia
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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.
|
3.4%
1/29 • 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
Lesion on lip after biting lip
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Alanine aminotransferase increased
|
46.9%
15/32 • Number of events 47 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
34.5%
10/29 • 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.
|
|
Investigations
Alkaline phosphatase increased
|
15.6%
5/32 • 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.
|
13.8%
4/29 • 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.
|
|
Investigations
Aspartate aminotransferase increased
|
40.6%
13/32 • 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.
|
20.7%
6/29 • 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.
|
|
Investigations
Blood bilirubin increased
|
12.5%
4/32 • 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.
|
6.9%
2/29 • 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
CD4 lymphocytes decreased
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Investigations
Cholesterol high
|
43.8%
14/32 • 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.
|
27.6%
8/29 • 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
Creatinine increased
|
9.4%
3/32 • 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.
|
13.8%
4/29 • 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.
|
|
Investigations
Lymphocyte count decreased
|
62.5%
20/32 • 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.
|
72.4%
21/29 • 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
|
40.6%
13/32 • 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.
|
41.4%
12/29 • 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.
|
|
Investigations
Platelet count decreased
|
59.4%
19/32 • Number of events 78 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
48.3%
14/29 • 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
Weight loss
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
White blood cell decreased
|
56.2%
18/32 • Number of events 63 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
62.1%
18/29 • Number of events 65 • 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
|
21.9%
7/32 • 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.
|
20.7%
6/29 • 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
Hyperglycemia
|
50.0%
16/32 • Number of events 48 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
58.6%
17/29 • 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.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.1%
1/32 • 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.
|
6.9%
2/29 • 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.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
2/32 • 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%
0/29 • 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
Hypernatremia
|
3.1%
1/32 • 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.
|
3.4%
1/29 • 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
|
43.8%
14/32 • 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.
|
37.9%
11/29 • Number of events 35 • 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
|
43.8%
14/32 • 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.
|
24.1%
7/29 • 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.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.9%
7/32 • 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.
|
10.3%
3/29 • 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
Hypoglycemia
|
3.1%
1/32 • 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.
|
6.9%
2/29 • 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.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
37.5%
12/32 • Number of events 37 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
24.1%
7/29 • 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.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
16/32 • 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.
|
31.0%
9/29 • 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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
46.9%
15/32 • Number of events 41 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
48.3%
14/29 • Number of events 31 • 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
|
18.8%
6/32 • 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.
|
20.7%
6/29 • 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.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Arthralgia
|
3.1%
1/32 • 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%
0/29 • 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
Arthritis
|
3.1%
1/32 • 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%
0/29 • 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
|
6.2%
2/32 • 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.
|
13.8%
4/29 • 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
Bone pain
|
3.1%
1/32 • 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%
0/29 • 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
Deconditioning
|
3.1%
1/32 • 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%
0/29 • 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
|
6.2%
2/32 • 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.
|
3.4%
1/29 • 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
Myalgia
|
9.4%
3/32 • 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%
0/29 • 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
|
15.6%
5/32 • 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.
|
13.8%
4/29 • 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
difficulty dosiflexing rt foot
|
3.1%
1/32 • 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%
0/29 • 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
joint discomfort & instability
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
shaking chills
|
3.1%
1/32 • 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%
0/29 • 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
|
15.6%
5/32 • 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.
|
13.8%
4/29 • 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.
|
|
Nervous system disorders
Dysgeusia
|
3.1%
1/32 • 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.
|
3.4%
1/29 • 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
Encephalopathy
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
|
18.8%
6/32 • 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.
|
3.4%
1/29 • 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
Lightheadedness
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Peripheral sensory neuropathy
|
6.2%
2/32 • 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.
|
13.8%
4/29 • 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
Somnolence
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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.
|
20.7%
6/29 • 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.
|
|
Nervous system disorders
lightheadedness
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
Anxiety
|
9.4%
3/32 • 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.
|
3.4%
1/29 • 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
|
3.1%
1/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
Depression
|
9.4%
3/32 • 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%
0/29 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
|
Psychiatric disorders
Insomnia
|
15.6%
5/32 • 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.
|
6.9%
2/29 • 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.
|
|
Renal and urinary disorders
Bladder spasm
|
3.1%
1/32 • 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%
0/29 • 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
Cystitis noninfective
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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%
0/29 • 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
Nocturia
|
3.1%
1/32 • 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%
0/29 • 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
|
6.2%
2/32 • 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%
0/29 • 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
|
6.2%
2/32 • 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%
0/29 • 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 retention
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Urinary tract pain
|
3.1%
1/32 • 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%
0/29 • 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
bladder pain
|
3.1%
1/32 • 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%
0/29 • 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
|
3.1%
1/32 • 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.
|
17.2%
5/29 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • 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.
|
6.9%
2/29 • 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
Epistaxis
|
3.1%
1/32 • 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%
0/29 • 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
|
6.2%
2/32 • 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%
0/29 • 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
|
12.5%
4/32 • 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.
|
6.9%
2/29 • 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
Pleural effusion
|
6.2%
2/32 • 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%
0/29 • 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
Postnasal drip
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Productive cough
|
3.1%
1/32 • 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.
|
3.4%
1/29 • 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
Pulmonary edema
|
9.4%
3/32 • 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%
0/29 • 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
|
6.2%
2/32 • 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.
|
13.8%
4/29 • 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%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Acne Pustules
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
|
9.4%
3/32 • 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.
|
10.3%
3/29 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema at injection site
|
3.1%
1/32 • 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%
0/29 • 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
|
6.2%
2/32 • 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.
|
17.2%
5/29 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritis at injection site
|
3.1%
1/32 • 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%
0/29 • 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
|
15.6%
5/32 • 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.
|
20.7%
6/29 • 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
Purpura
|
3.1%
1/32 • 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%
0/29 • 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
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
|
9.4%
3/32 • 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.
|
48.3%
14/29 • Number of events 37 • 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
|
3.1%
1/32 • 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.
|
3.4%
1/29 • 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
Skin lesions
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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
Hypertension
|
65.6%
21/32 • Number of events 73 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
65.5%
19/29 • 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.
|
|
Vascular disorders
Hypotension
|
9.4%
3/32 • 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.
|
6.9%
2/29 • 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.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/32 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
|
3.4%
1/29 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place