Trial Outcomes & Findings for Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer (NCT NCT00540995)
NCT ID: NCT00540995
Last Updated: 2023-11-30
Results Overview
The highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study treatment when at least six patients were treated at the dose and are evaluable for toxicity. The MDT is one dose level below the DLT level. At least six patients will be treated at the MTD.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
from initial treatment date to Day 30 post-transplant
Results posted on
2023-11-30
Participant Flow
Participant milestones
| Measure |
Arm I: 1200cGy
1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate.
busulfan: Given IV
etoposide: Given IV
intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
|
Arm II: 1350cGy
1350cGy = 150cGy x 9 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
busulfan: Given IV
etoposide: Given IV
intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
2
|
|
Overall Study
COMPLETED
|
23
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer
Baseline characteristics by cohort
| Measure |
Arm I: 1200cGy
n=23 Participants
1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate.
busulfan: Given IV
etoposide: Given IV
intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
|
Arm II: 1350cGy
n=2 Participants
1350cGy = 150cGy x 9 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
busulfan: Given IV
etoposide: Given IV
intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
36 years
n=7 Participants
|
40 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
2 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from initial treatment date to Day 30 post-transplantPopulation: 6 patients treated at dose level one (1200cGy) are evaluable for dose limiting evaluable in Phase I.
The highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study treatment when at least six patients were treated at the dose and are evaluable for toxicity. The MDT is one dose level below the DLT level. At least six patients will be treated at the MTD.
Outcome measures
| Measure |
Arm I: 1200cGy
n=6 Participants
1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate.
busulfan: Given IV
etoposide: Given IV
intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Intensity-modulated Radiation Therapy (Phase I)
|
1200 cGy
|
Adverse Events
Arm I: 1200cGy
Serious events: 7 serious events
Other events: 23 other events
Deaths: 19 deaths
Arm II: 1350cGy
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm I: 1200cGy
n=23 participants at risk
1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate.
busulfan: Given IV
etoposide: Given IV
intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
|
Arm II: 1350cGy
n=2 participants at risk
1350cGy = 150cGy x 9 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
busulfan: Given IV
etoposide: Given IV
intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Infections and infestations
Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Syndromes - Other (Specify, __)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
Other adverse events
| Measure |
Arm I: 1200cGy
n=23 participants at risk
1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate.
busulfan: Given IV
etoposide: Given IV
intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
|
Arm II: 1350cGy
n=2 participants at risk
1350cGy = 150cGy x 9 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
busulfan: Given IV
etoposide: Given IV
intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy
tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
|
|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Veno-Occlusive Disease (VOD)
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
95.7%
22/23 • Number of events 22 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Blood and lymphatic system disorders
Iron overload
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
91.3%
21/23 • Number of events 21 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
95.7%
22/23 • Number of events 22 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
87.0%
20/23 • Number of events 20 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Blood and lymphatic system disorders
Platelets
|
95.7%
22/23 • Number of events 22 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets for BMT studies, if specified in the protocol.
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs for BMT studies, if specified in the protocol.
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
95.7%
22/23 • Number of events 22 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Cardiac disorders
Hypertension
|
39.1%
9/23 • Number of events 9 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Cardiac disorders
Hypotension
|
34.8%
8/23 • Number of events 8 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Cardiac disorders
Myocarditis
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Cardiac disorders
Pericarditis
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Cardiac disorders
Valvular heart disease
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Vascular disorders
INR (International Normalized Ratio of prothrombin time)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Vascular disorders
PTT (Partial Thromboplastin Time)
|
26.1%
6/23 • Number of events 6 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Vascular disorders
Thrombotic microangiopathy
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
23/23 • Number of events 23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Fever (in the absence of neutropenia, ANC <1.0 x 10e9/L)
|
34.8%
8/23 • Number of events 8 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Insomnia
|
78.3%
18/23 • Number of events 18 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Rigors/chills
|
69.6%
16/23 • Number of events 16 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Sweating (diaphoresis)
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Weight gain
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Weight loss
|
43.5%
10/23 • Number of events 10 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
60.9%
14/23 • Number of events 14 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
60.9%
14/23 • Number of events 14 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
26.1%
6/23 • Number of events 6 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
82.6%
19/23 • Number of events 19 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (skin and subcutaneous tissue)
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
34.8%
8/23 • Number of events 8 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
34.8%
8/23 • Number of events 8 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
95.7%
22/23 • Number of events 22 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation
|
26.1%
6/23 • Number of events 6 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
47.8%
11/23 • Number of events 11 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Anorexia
|
69.6%
16/23 • Number of events 16 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Colitis
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Constipation
|
34.8%
8/23 • Number of events 8 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Dehydration
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Diarrhea
|
82.6%
19/23 • Number of events 19 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
56.5%
13/23 • Number of events 13 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
13.0%
3/23 • Number of events 3 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Esophagitis
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Flatulence
|
21.7%
5/23 • Number of events 5 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
52.2%
12/23 • Number of events 12 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Hemorrhoids
|
26.1%
6/23 • Number of events 6 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Incontinence, anal
|
13.0%
3/23 • Number of events 3 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
95.7%
22/23 • Number of events 22 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
95.7%
22/23 • Number of events 22 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
23/23 • Number of events 23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Proctitis
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Gastrointestinal disorders
Vomiting
|
95.7%
22/23 • Number of events 22 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Vascular disorders
Hemorrhage, GI
|
39.1%
9/23 • Number of events 9 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Vascular disorders
Hemorrhage, GU
|
34.8%
8/23 • Number of events 8 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory
|
39.1%
9/23 • Number of events 9 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Vascular disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Hepatobiliary disorders
Cholecystitis
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (Specify, __)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Infections and infestations
Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
|
56.5%
13/23 • Number of events 13 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
|
56.5%
13/23 • Number of events 13 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
21.7%
5/23 • Number of events 5 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Infections and infestations
Infection, Bacterial (COH)
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Infections and infestations
Infection, Fungal (COH)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Edema:head and neck
|
47.8%
11/23 • Number of events 11 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Edema:limb
|
91.3%
21/23 • Number of events 21 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Edema:trunk/genital
|
30.4%
7/23 • Number of events 7 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
69.6%
16/23 • Number of events 16 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
87.0%
20/23 • Number of events 20 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Acidosis (metabolic or respiratory)
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
91.3%
21/23 • Number of events 21 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Alkaline phosphatase
|
87.0%
20/23 • Number of events 20 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Alkalosis (metabolic or respiratory)
|
13.0%
3/23 • Number of events 3 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Bicarbonate, serum-low
|
65.2%
15/23 • Number of events 15 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
39.1%
9/23 • Number of events 9 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
CPK (creatine phosphokinase)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
26.1%
6/23 • Number of events 6 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
91.3%
21/23 • Number of events 21 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
21.7%
5/23 • Number of events 5 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Creatinine
|
30.4%
7/23 • Number of events 7 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
91.3%
21/23 • Number of events 21 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
30.4%
7/23 • Number of events 7 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
91.3%
21/23 • Number of events 21 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
82.6%
19/23 • Number of events 19 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
26.1%
6/23 • Number of events 6 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
91.3%
21/23 • Number of events 21 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Proteinuria
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
30.4%
7/23 • Number of events 7 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
95.7%
22/23 • Number of events 22 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
87.0%
20/23 • Number of events 20 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
21.7%
5/23 • Number of events 5 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
56.5%
13/23 • Number of events 13 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Nervous system disorders
Confusion
|
39.1%
9/23 • Number of events 9 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Nervous system disorders
Dizziness
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Nervous system disorders
Mood alteration
|
91.3%
21/23 • Number of events 21 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Nervous system disorders
Neuropathy: cranial
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Nervous system disorders
Neuropathy: motor
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Nervous system disorders
Neuropathy: sensory
|
13.0%
3/23 • Number of events 3 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Nervous system disorders
Tremor
|
26.1%
6/23 • Number of events 6 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Eye disorders
Dry eye syndrome
|
34.8%
8/23 • Number of events 8 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Eye disorders
Vision-blurred vision
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
General disorders
Pain
|
100.0%
23/23 • Number of events 23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
34.8%
8/23 • Number of events 8 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
65.2%
15/23 • Number of events 15 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
43.5%
10/23 • Number of events 10 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
100.0%
2/2 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
FEV(1)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
21.7%
5/23 • Number of events 5 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
21.7%
5/23 • Number of events 5 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
39.1%
9/23 • Number of events 9 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
13.0%
3/23 • Number of events 3 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Renal and urinary disorders
Cystitis
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Renal and urinary disorders
Incontinence, urinary
|
13.0%
3/23 • Number of events 3 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Renal and urinary disorders
Renal failure
|
21.7%
5/23 • Number of events 5 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
8.7%
2/23 • Number of events 2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Renal and urinary disorders
Urine color change
|
13.0%
3/23 • Number of events 3 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Reproductive system and breast disorders
Vaginal discharge (non-infectious)
|
0.00%
0/23 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
50.0%
1/2 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Reproductive system and breast disorders
Vaginitis (not due to infection)
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Syndromes - Other (Specify, __)
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Investigations
Tumor lysis syndrome
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
17.4%
4/23 • Number of events 4 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.3%
1/23 • Number of events 1 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
0.00%
0/2 • Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
|
Additional Information
Dr. Anthony Stein
City of Hope Medical Center
Phone: 626-359-8111
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place