NCT00369564 · ADVERSE EVENTS

Adverse events

Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer · Source last updated 2021-08-11

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: 10 weeks
Other-event reporting threshold: 5%

Subjects and parents completed daily study medication logs and noted any adverse events or symptoms. Site personnel reviewed study medication logs with subjects to assess for adverse events and completed an in-person neurological exam and chemistry profile at weeks 5 and 10 to assess for adverse events. Adverse events reviewed by independent DSMB.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I Glutamic Acid Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).	9 / 127	16 / 127	Not reported / Not reported
Arm II Placebo Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).	6 / 123	5 / 123	Not reported / Not reported

Group identifiers: EG000: Arm I Glutamic Acid · EG001: Arm II Placebo

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
127
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Adrenal Insufficiency
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
127
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Tumor lysis syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
127
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Colitis, infectious (e.g., Clostridium difficile)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
1
num At Risk
123
num Events
2
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Infection-Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
2
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Infection with unknown ANC
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Bilirubin (hyperbilirubinemia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Cognitive disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Confusion

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
127
num Events
10
group Id
EG001
num Affected
3
num At Risk
123
num Events
3
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
127
num Events
7
group Id
EG001
num Affected
3
num At Risk
123
num Events
6
term
Pain

Complete source fields

description

event Groups

description
Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
id
EG000
other Num Affected
16
other Num At Risk
127
serious Num Affected
9
serious Num At Risk
127
title
Arm I Glutamic Acid
description
Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
id
EG001
other Num Affected
5
other Num At Risk
123
serious Num Affected
6
serious Num At Risk
123
title
Arm II Placebo

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
127
num Events
10
group Id
EG001
num Affected
3
num At Risk
123
num Events
3
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
127
num Events
7
group Id
EG001
num Affected
3
num At Risk
123
num Events
6
term
Pain

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
127
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Adrenal Insufficiency
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
127
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Tumor lysis syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
127
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Colitis, infectious (e.g., Clostridium difficile)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
1
num At Risk
123
num Events
2
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Infection-Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
2
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Infection with unknown ANC
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Bilirubin (hyperbilirubinemia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Cognitive disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
127
num Events
1
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Confusion

time Frame

10 weeks

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Preserved source evidence · Not medical advice