NCT00024258 · ADVERSE EVENTS

Adverse events

Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors · Source last updated 2015-11-25

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: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arsenic Trioxide Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.	12 / 22	14 / 22	Not reported / Not reported

Group identifiers: EG000: Arsenic Trioxide

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
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Hyperkalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Hypocalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
4
num At Risk
22
num Events
4
term
Infection NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Neuralgia

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
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
15
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
4
num At Risk
22
num Events
4
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Bruising
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
4
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dry Eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Febrile Neutropenia

Complete source fields

event Groups

description
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.
id
EG000
other Num Affected
14
other Num At Risk
22
serious Num Affected
12
serious Num At Risk
22
title
Arsenic Trioxide

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
15
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
4
num At Risk
22
num Events
4
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Bruising
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
4
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dry Eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Febrile Neutropenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Hyperkalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Hypocalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
4
num At Risk
22
num Events
4
term
Infection NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Neuralgia

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

Preserved source evidence · Not medical advice