NCT00540995 · ADVERSE EVENTS

Adverse events

Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer · Source last updated 2023-11-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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	7 / 23	23 / 23	19 / 23
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	2 / 2	2 / 2	2 / 2

Group identifiers: EG000: Arm I: 1200cGy · EG001: Arm II: 1350cGy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Ascites (non-malignant)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Mucositis/stomatitis (clinical exam)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Mucositis/stomatitis (functional/symptomatic)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Colitis, infectious (e.g., Clostridium difficile)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
23
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Adult Respiratory Distress Syndrome (ARDS)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Syndromes - Other (Specify, __)

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
23
num Events
4
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Allergic reaction/hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
23
num Events
4
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Veno-Occlusive Disease (VOD)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
22
num At Risk
23
num Events
22
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Iron overload
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
21
num At Risk
23
num Events
21
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
22
num At Risk
23
num Events
22
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
23
num Events
20
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Neutrophils/granulocytes (ANC/AGC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
22
num At Risk
23
num Events
22
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Transfusion: Platelets for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Transfusion: pRBCs for BMT studies, if specified in the protocol.

Complete source fields

event Groups

deaths Num Affected
19
deaths Num At Risk
23
description
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
id
EG000
other Num Affected
23
other Num At Risk
23
serious Num Affected
7
serious Num At Risk
23
title
Arm I: 1200cGy
deaths Num Affected
2
deaths Num At Risk
2
description
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
id
EG001
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Arm II: 1350cGy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
23
num Events
4
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Allergic reaction/hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
23
num Events
4
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Veno-Occlusive Disease (VOD)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
22
num At Risk
23
num Events
22
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Iron overload
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
21
num At Risk
23
num Events
21
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
22
num At Risk
23
num Events
22
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
23
num Events
20
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Neutrophils/granulocytes (ANC/AGC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
22
num At Risk
23
num Events
22
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Transfusion: Platelets for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
term
Transfusion: pRBCs for BMT studies, if specified in the protocol.

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Ascites (non-malignant)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Mucositis/stomatitis (clinical exam)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Mucositis/stomatitis (functional/symptomatic)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Colitis, infectious (e.g., Clostridium difficile)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
23
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Adult Respiratory Distress Syndrome (ARDS)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Syndromes - Other (Specify, __)

time Frame

Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice