NCT00381680 · ADVERSE EVENTS

Adverse events

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia · Source last updated 2024-03-26

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: Not reported
Other-event reporting threshold: 0%

Only eligible patients are included in the toxicity adverse events for both serious and other.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Regimen A: Standard Vincristine Dosing See detailed description. vincristine sulfate: Given IV prednisone: Given PO doxorubicin hydrochloride: Given IV pegaspargase: Given IM cytarabine: Given IT or IV methotrexate: Given IT or IV dexamethasone: Given PO etoposide: Given IV cyclophosphamide: Given IV leucovorin calcium: Given IV or PO filgrastim: Given IV or SC asparaginase: Given IM mercaptopurine: Given PO	40 / 203	189 / 203	Not reported / Not reported
Arm B: Randomized High Dose Vincristine Regimen See detailed description. Closed to accrual as of 09/2010). vincristine sulfate: Given IV prednisone: Given PO doxorubicin hydrochloride: Given IV pegaspargase: Given IM cytarabine: Given IT or IV methotrexate: Given IT or IV dexamethasone: Given PO etoposide: Given IV cyclophosphamide: Given IV leucovorin calcium: Given IV or PO filgrastim: Given IV or SC asparaginase: Given IM mercaptopurine: Given PO	11 / 68	66 / 68	Not reported / Not reported

Group identifiers: EG000: Regimen A: Standard Vincristine Dosing · EG001: Arm B: Randomized High Dose Vincristine Regimen

Serious adverse events

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

organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
4
num At Risk
203
num Events
4
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Febrile neutropenia
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
2
num At Risk
203
num Events
2
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Sinus tachycardia
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Ventricular arrhythmia
organ System
Gastrointestinal disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Abdominal pain
organ System
Gastrointestinal disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Anal necrosis
organ System
Gastrointestinal disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Anal ulcer
organ System
General disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
15
num At Risk
203
num Events
15
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Death NOS
organ System
General disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Edema face
organ System
General disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Fever
organ System
General disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
2
num At Risk
203
num Events
2
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Multi-organ failure
organ System
Hepatobiliary disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Hepatic failure

Other reported adverse events

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

organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
51
num At Risk
203
num Events
102
group Id
EG001
num Affected
22
num At Risk
68
num Events
40
term
Anemia
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Bone marrow hypocellular
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
127
num At Risk
203
num Events
250
group Id
EG001
num Affected
48
num At Risk
68
num Events
89
term
Febrile neutropenia
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
2
num At Risk
203
num Events
2
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Hemolysis
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Leukocytosis
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Cardiac arrest
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Chest pain - cardiac
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Heart failure
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
4
num At Risk
203
num Events
4
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Left ventricular systolic dysfunction
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Myocarditis
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Sinus tachycardia

Complete source fields

description

Only eligible patients are included in the toxicity adverse events for both serious and other.

event Groups

description
See detailed description. vincristine sulfate: Given IV prednisone: Given PO doxorubicin hydrochloride: Given IV pegaspargase: Given IM cytarabine: Given IT or IV methotrexate: Given IT or IV dexamethasone: Given PO etoposide: Given IV cyclophosphamide: Given IV leucovorin calcium: Given IV or PO filgrastim: Given IV or SC asparaginase: Given IM mercaptopurine: Given PO
id
EG000
other Num Affected
189
other Num At Risk
203
serious Num Affected
40
serious Num At Risk
203
title
Regimen A: Standard Vincristine Dosing
description
See detailed description. Closed to accrual as of 09/2010). vincristine sulfate: Given IV prednisone: Given PO doxorubicin hydrochloride: Given IV pegaspargase: Given IM cytarabine: Given IT or IV methotrexate: Given IT or IV dexamethasone: Given PO etoposide: Given IV cyclophosphamide: Given IV leucovorin calcium: Given IV or PO filgrastim: Given IV or SC asparaginase: Given IM mercaptopurine: Given PO
id
EG001
other Num Affected
66
other Num At Risk
68
serious Num Affected
11
serious Num At Risk
68
title
Arm B: Randomized High Dose Vincristine Regimen

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
51
num At Risk
203
num Events
102
group Id
EG001
num Affected
22
num At Risk
68
num Events
40
term
Anemia
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Bone marrow hypocellular
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
127
num At Risk
203
num Events
250
group Id
EG001
num Affected
48
num At Risk
68
num Events
89
term
Febrile neutropenia
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
2
num At Risk
203
num Events
2
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Hemolysis
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Leukocytosis
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Cardiac arrest
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Chest pain - cardiac
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Heart failure
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
4
num At Risk
203
num Events
4
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Left ventricular systolic dysfunction
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Myocarditis
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Sinus tachycardia

serious Events

organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
4
num At Risk
203
num Events
4
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Febrile neutropenia
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
2
num At Risk
203
num Events
2
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Sinus tachycardia
organ System
Cardiac disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Ventricular arrhythmia
organ System
Gastrointestinal disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Abdominal pain
organ System
Gastrointestinal disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Anal necrosis
organ System
Gastrointestinal disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Anal ulcer
organ System
General disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
15
num At Risk
203
num Events
15
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Death NOS
organ System
General disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Edema face
organ System
General disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
68
num Events
0
term
Fever
organ System
General disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
2
num At Risk
203
num Events
2
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Multi-organ failure
organ System
Hepatobiliary disorders
source Vocabulary
CTCV4
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
68
num Events
1
term
Hepatic failure

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