Trial Outcomes & Findings for Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer (NCT NCT00534430)
NCT ID: NCT00534430
Last Updated: 2025-06-03
Results Overview
Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Date of Transplant to Five Years post-Transplant
Results posted on
2025-06-03
Participant Flow
Participant milestones
| Measure |
Busulfan, Fractionated Total Body Irradiation (FTBI) + Etoposide (VP16)
IV Busulfan + 12 cGy Fractionated Total Body Irradiation (FTBI) + Etoposide (VP16) prior to allogeneic Bone Marrow Transplant
busulfan
cyclosporine
etoposide
mycophenolate mofetil
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patients with active disease
Baseline characteristics by cohort
| Measure |
Busulfan, FTBI and VP16
n=30 Participants
IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
busulfan
cyclosporine
etoposide
mycophenolate mofetil
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
|
|---|---|
|
Age, Continuous
|
37 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White, Not Hispanic
|
22 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
|
Patient Assessment of Mortality (PAM) Score
|
26 units on a scale
n=30 Participants
|
|
Disease Status at Transplant
AML in First Complete Remission
|
6 Participants
n=30 Participants
|
|
Disease Status at Transplant
AML in First Relapse
|
6 Participants
n=30 Participants
|
|
Disease Status at Transplant
AML in Induction Failure
|
10 Participants
n=30 Participants
|
|
Disease Status at Transplant
untreated RAEB-t
|
2 Participants
n=30 Participants
|
|
Disease Status at Transplant
ALL in First Relapse
|
1 Participants
n=30 Participants
|
|
Disease Status at Transplant
ALL in Second Relapse
|
1 Participants
n=30 Participants
|
|
Disease Status at Transplant
ALL in Induction Failure
|
4 Participants
n=30 Participants
|
|
Cytogenetics
Indeterminate
|
1 Participants
n=30 Participants
|
|
Cytogenetics
Intermediate
|
14 Participants
n=30 Participants
|
|
Cytogenetics
Unfavorable
|
15 Participants
n=30 Participants
|
|
Stem Cell Source
Bone Marrow
|
1 Participants
n=30 Participants
|
|
Stem Cell Source
Peripheral Blood
|
29 Participants
n=30 Participants
|
|
WBC pre-conditioning
|
3.4 x10^9 cells/L
n=24 Participants • Patients with active disease
|
|
Percent Blasts in Bone Marrow
|
16.5 percent of leukocytes
n=24 Participants • Patients with active disease
|
|
Percent Blasts in Peripheral Blood
|
3.5 percent of leukocytes
n=24 Participants • Patients with Active Disease
|
PRIMARY outcome
Timeframe: Date of Transplant to Five Years post-TransplantPopulation: The Full Study Population
Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
Outcome measures
| Measure |
Busulfan, FTBI and VP16
n=30 Participants
IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
busulfan
cyclosporine
etoposide
mycophenolate mofetil
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
|
AML/R1
Acute Myelogenous Leukemia Transplanted in First Relapse
|
AML/IF
Acute Myelogenous Leukemia Transplanted in Induction Failure
|
Active ALL
Active Acute Lymphocytic Leukemia
|
|---|---|---|---|---|
|
Overall Survival at 5 Years Post-Transplant.
|
40 percentage of survival probability
Interval 23.0 to 57.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Date of transplant to five years post-transplantKaplan-Meier estimate of an event of relapse or death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
Outcome measures
| Measure |
Busulfan, FTBI and VP16
n=30 Participants
IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
busulfan
cyclosporine
etoposide
mycophenolate mofetil
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
|
AML/R1
Acute Myelogenous Leukemia Transplanted in First Relapse
|
AML/IF
Acute Myelogenous Leukemia Transplanted in Induction Failure
|
Active ALL
Active Acute Lymphocytic Leukemia
|
|---|---|---|---|---|
|
Disease-free Survival at Five Years Post-transplant
|
40 percentage of survival probability
Interval 23.0 to 57.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Date of Transplant to Five Years post-TransplantPopulation: Study cohort separated into four disease groups.
Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
Outcome measures
| Measure |
Busulfan, FTBI and VP16
n=6 Participants
IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
busulfan
cyclosporine
etoposide
mycophenolate mofetil
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
|
AML/R1
n=6 Participants
Acute Myelogenous Leukemia Transplanted in First Relapse
|
AML/IF
n=10 Participants
Acute Myelogenous Leukemia Transplanted in Induction Failure
|
Active ALL
n=6 Participants
Active Acute Lymphocytic Leukemia
|
|---|---|---|---|---|
|
Overall Survival Comparing Diagnosis Groups
|
67 percentage of survival probability
Interval 20.0 to 90.0
|
50 percentage of survival probability
Interval 11.0 to 80.0
|
30 percentage of survival probability
Interval 7.0 to 38.0
|
33 percentage of survival probability
Interval 5.0 to 38.0
|
PRIMARY outcome
Timeframe: Date of Transplant to Five Years post-Transplant. Estimate is at Five Years post-Transplant.Fine and Gray estimate of cumulative incidence of Relapse, with Death as the competing risk. Estimate is at five years post-transplant. Ninety-five percent confidence interval is by logit transformation of Greenwood variance to keep the interval within the probability space of 0% to 100%.
Outcome measures
| Measure |
Busulfan, FTBI and VP16
n=6 Participants
IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
busulfan
cyclosporine
etoposide
mycophenolate mofetil
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
|
AML/R1
n=6 Participants
Acute Myelogenous Leukemia Transplanted in First Relapse
|
AML/IF
n=10 Participants
Acute Myelogenous Leukemia Transplanted in Induction Failure
|
Active ALL
n=6 Participants
Active Acute Lymphocytic Leukemia
|
|---|---|---|---|---|
|
Cumulative Incidence of Relapse With Transplant-related Death as the Competing Risk: Diagnosis Groups Are Compared.
|
0 percentage of relapse probability
Interval 0.0 to 0.0
|
0 percentage of relapse probability
Interval 0.0 to 0.0
|
30 percentage of relapse probability
Interval 9.0 to 65.0
|
50 percentage of relapse probability
Interval 13.0 to 87.0
|
Adverse Events
Busulfan, FTBI and VP16
Serious events: 2 serious events
Other events: 30 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Busulfan, FTBI and VP16
n=30 participants at risk
IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
busulfan
cyclosporine
etoposide
mycophenolate mofetil
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Anorexia
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
Other adverse events
| Measure |
Busulfan, FTBI and VP16
n=30 participants at risk
IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
busulfan
cyclosporine
etoposide
mycophenolate mofetil
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Immune system disorders
Allergy/Immunology - Other: DRY NOSE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Immune system disorders
Allergy/Immunology - Other: ENGRAFTMENT SYNDROME
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other: DECREASED HEARING DUETO MEDS (AZITHROMYCIN)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other: PLUGGED EARS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Ear and labyrinth disorders
Otitis, external ear (non-infectious)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Graft versus host disease
|
46.7%
14/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Veno-Occlusive Disease (VOD)
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, __)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Bone marrow cellularity
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
80.0%
24/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Hemoglobin for leukemia studies or bone marrow infiltrative/ myelophthisic processes.
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
|
76.7%
23/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
73.3%
22/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
|
80.0%
24/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Platelets
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Platelets for BMT studies, if specified in the protocol.
|
83.3%
25/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets for BMT studies, if specified in the protocol.
|
76.7%
23/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs for BMT studies, if specified in the protocol.
|
83.3%
25/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Acute graft versus host disease (GVHD) (COH)
|
50.0%
15/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Chronic graft versus host disease (GVHD) (COH)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
63.3%
19/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Cardiac disorders
Cardiac General - Other: CARDIOMEGALY
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Cardiac disorders
Hypertension
|
56.7%
17/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Cardiac disorders
Hypotension
|
26.7%
8/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Cardiac disorders
Myocarditis
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Edema
|
66.7%
20/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
INR (International Normalized Ratio of prothrombin time)
|
26.7%
8/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
PTT (Partial Thromboplastin Time)
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
76.7%
23/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
40.0%
12/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Insomnia
|
43.3%
13/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Rigors/chills
|
66.7%
20/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Sweating (diaphoresis)
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Weight gain
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Weight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified in the protocol.
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Weight loss
|
53.3%
16/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: ACTINIC PARAKERATIONS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: BRUISE ON RIGHT ARM
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: BURNING SENSATION IN ARM PITS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: CONTACT DERMATITIS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: DIFFUSE ERYTHEMATOUS SCROTUM
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: EDEMA DUE TO BM BIOPSY
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: FACIAL PLETHORA
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: FACIAL SWELLING
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: INGROWN TOENAIL
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: INTRAVASCULAR MICROTHROMBI - LEFT THIGH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: LEFT HIP ABRASION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: LIP LESION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: PALLOR
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: PAROTID SWELLING
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: PERI-RECTAL EXCORIATION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: PERIANAL AREA SKIN IRRITATION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: PERIRECTAL AREA SKIN IRRITATION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: PERIRECTAL ULCER
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: RASH SECONDARY CHEMO
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: REDNESS ON SCROTUM
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: ROSACEA
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: SCROTAL RASH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: SKIN/JAUNDICE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: UP ORAL ULCER
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: VP-16 RASH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: VP-16 SKIN RASH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.3%
7/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
26.7%
8/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
33.3%
10/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
16.7%
5/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
40.0%
12/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
30.0%
9/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
|
16.7%
5/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
23.3%
7/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation associated with graft versus host disease (GVHD).
|
60.0%
18/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
33.3%
10/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
20.0%
6/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Anorexia
|
83.3%
25/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Colitis
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Constipation
|
23.3%
7/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Dehydration
|
40.0%
12/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Diarrhea
|
36.7%
11/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Diarrhea associated with graft versus host disease (GVHD)
|
46.7%
14/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Dysphagia-esophageal related to radiation
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Esophagitis
|
30.0%
9/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: ABDOMINAL BLOATING
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: ABDOMINAL BLOATNESS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: ABDOMINAL CRAMPS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: ABDOMINAL DISTENSION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: CHOLECYSTITIS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: DRY HEAVES
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: DRY MOUTH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: EPIGASTRIC DISCOMFORT
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: ERYTHEMA STOMACH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: ESOPHAGEAL DISCOMFORT
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: FREQUENT STOOLS (NOT DIARRHEA)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: GAGGING
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: GERD
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: GURGLY STOMACH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: INCREASED SALIVATION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: ORAL THRUSH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: RECTAL LESION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: RED THROAT
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: RETCHING
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: SCRATCHY THROAT
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: SMALL POLYPS STOMACH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: SWELLING OF CHECKS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: UPPER GI/GVHD
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: WRECHING
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Gastrointestinal - Other: WRETCHING
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
53.3%
16/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
25/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
16.7%
5/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol.
|
80.0%
24/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Gastrointestinal disorders
Vomiting
|
73.3%
22/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hematemesis
|
26.7%
8/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hematuria (in the absence of vaginal bleeding)
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemoptysis
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
53.3%
16/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
46.7%
14/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Melena/GI bleeding
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Rectal bleeding/hematochezia
|
16.7%
5/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage, GU
|
30.0%
9/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory
|
30.0%
9/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other: BLEEDING FROM PENIS MEATUS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other: BLEEDING FROM SCRATCH
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other: BLOOD IN SPUTUM
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other: BLOOD TINGLED MUCUS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other: HEMORRHOIDS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other: SPUTUM WITH BLOODSTREAM
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other: SUBCONJUNCTIVAL HEMORRHAGE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other: TELANGIECTASIA CHEST
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other: TONGUE BLEEDING
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
26.7%
8/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Hepatobiliary disorders
Bilirubin associated with graft versus host disease (GVHD).
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Hepatobiliary disorders
Hepatic enlargement
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other: JAUNDICE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin)
|
73.3%
22/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Infection - Other (Specify, __)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Infection - Other: ORAL CANDIDIASIS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Infection - Other: UPPER RESPIRATORY INFECTION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Infection with unknown ANC
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Infection (documented) with grade 3 or 4 neutropenia
|
33.3%
10/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Infection without neutropenia
|
70.0%
21/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Infection, Bacterial (COH)
|
66.7%
20/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Infection, Fungal (COH)
|
30.0%
9/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Infections and infestations
Infection, Viral
|
60.0%
18/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Lymphatics - Other: LYMPHADENOPATHY
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Lymphatics CERVICAL LYMPHOADENOPATHY
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Blood and lymphatic system disorders
Lymphatics MILD LYMPHEDEMIA (NECK)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
86.7%
26/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
80.0%
24/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
86.7%
26/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
60.0%
18/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
70.0%
21/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
53.3%
16/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
83.3%
25/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
40.0%
12/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Creatinine
|
80.0%
24/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
86.7%
26/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
33.3%
10/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
90.0%
27/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
53.3%
16/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
46.7%
14/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
90.0%
27/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
90.0%
27/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
36.7%
11/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
16.7%
5/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other: DEGERATIVE CHANGES IN ANTERIOR THORACIC SPINE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other: HAND CRAMPS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other: MUSCLE CRAMPS
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other: MUSCLE CRAMPS-FINGERS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other: MUSCLE SPANAM
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other: MUSCLE SPASM
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other: NUMBNESS, TINGLING
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Ataxia (incoordination)
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Confusion
|
23.3%
7/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Dizziness
|
36.7%
11/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Hallucinations
|
16.7%
5/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Mood alteration
|
50.0%
15/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Neurology - Other: ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Neurology - Other: METABOLIC ENCEPHALOPATHY
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Neurology - Other: NIGHTMARES
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Neurology - Other: PANIC ATTACK
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Neuropathy: motor
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Neuropathy: sensory
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Personality/behavioral
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Pyramidal tract dysfunction (increased tone, hyperreflexia, pos Babinski, decreased motor coord
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
23.3%
7/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Syncope (fainting)
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Nervous system disorders
Tremor
|
30.0%
9/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Eye disorders
Dry eye syndrome
|
20.0%
6/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Eye disorders
Ocular surface disease
|
16.7%
5/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Eye disorders
Ocular/Visual - Other: CHEMON'S--SCLERAL EDEMA
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Eye disorders
Ocular/Visual - Other: ICTERIC SCLERAE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Eye disorders
Ocular/Visual - Other: JAUNDICED SCLERAL
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Eye disorders
Ocular/Visual - Other: RED EYES
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Eye disorders
Ocular/Visual - Other: REDNESS (NOT DRY)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Eye disorders
Ocular/Visual - Other: YELLOW DISCHARGE FROM THE EYES
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Eye disorders
Vision-blurred vision
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain
|
76.7%
23/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: ARM PIT PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: BACK PAIN
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: BODY ACHE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: CATHETER PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: CRAMPING (ABDOMINAL)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: DRY HEAVES
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: EAR PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: EPIGASTRIC PAIN
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: GENERALIZED BODY PAIN
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: HANDS PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: HICKMAN CATHETER PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: HICKMAN SITE PAIN
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: HIP PAIN (DUE TO BIOPSY)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: INGROWN TOENAIL PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: KNEE PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: LEG PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: LOW BACK PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: MOUTH PAIN
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: NECK PAIN
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: PAIN AT RAC SITE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: PAIN FROM BM BIOPSY SITE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: PAIN IN MANDIBLE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: PAIN SYNDROME DUE TO MUCOSITIS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: PAIN TO LYMPH NODE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: PAROTID PAIN
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: PERIRECTAL PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: R. ARM PAIN FROM THE FALL
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: RAC SITE PAIN
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: RIB PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: SCROTAL PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: SHOULDER PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: SKIN PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: SUBMANDIBULAR TENDERNESS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: TENDER PAROTID GLANDS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: THIGH PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: THROAT PAIN
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: THROAT PAIN (POSSIBLE URI)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: TONGUE PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain - Other: TWINGES FEET
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Pain RECTAL PAIN
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.7%
11/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
56.7%
17/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
13.3%
4/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
30.0%
9/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
26.7%
8/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: BRONCHOSPASM
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: DECREASED BREATH SOUND AT LUNG BASES
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: EXCORIATION OF POSTERIOR
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: MILD ELEVATION OF RIGHT HEMIDIAPHRAGM
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: NASAL CONGESTION
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: NASAL STUFFINESS
|
6.7%
2/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: NASAL/SINUS CONGESTION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: PULMONARY VASCULAR CONGESTION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: RESPIRATORY DISTRESS
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: RUNNING NOSE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: SINUS CONGESTION/RUNNY NOSE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: SINUS/NOSE CONGESTION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: TACHYPNEA
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: UPPER AIRWAY OBSTRUCTION
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: URI
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
30.0%
9/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Renal and urinary disorders
Bladder spasms
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Renal and urinary disorders
Incontinence
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other: VAG. DISCHARGE
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Reproductive system and breast disorders
Libido
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Reproductive system and breast disorders
Vaginitis (not due to infection)
|
10.0%
3/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Syndromes - Other: RASH GVHD
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
General disorders
Tumor lysis syndrome
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.3%
1/30 • From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
|
Additional Information
Anthony Stein, MD, Clinical Professor
Department of Hematology, City of Hope
Phone: 626-537-5748
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place