NCT00335738 · ADVERSE EVENTS

Adverse events

Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma · Source last updated 2021-02-18

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%

Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group 1 (Identified by Central Review as High Risk) Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	0 / 93	19 / 93	0 / 93
Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Group 1 (Identified by Central Review as High Risk) · EG001: Group 2 (Identified by Central Review as Not High Risk)

Serious adverse events

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

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
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Alanine aminotransferase increased
organ System
Immune system disorders
stats
group Id
EG000
num Affected
5
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Anaphylaxis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Anemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Anorexia
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Aspartate aminotransferase increased
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Constipation
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Dehydration
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Diarrhea
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Enterocolitis infectious
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Eye infection
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Febrile neutropenia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Headache

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
93
description
Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
id
EG000
other Num Affected
19
other Num At Risk
93
serious Num Affected
0
serious Num At Risk
93
title
Group 1 (Identified by Central Review as High Risk)
deaths Num Affected
0
deaths Num At Risk
0
description
Patients undergo observation periodically for at least 5 years.
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Group 2 (Identified by Central Review as Not High Risk)

frequency Threshold

other Events

organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Alanine aminotransferase increased
organ System
Immune system disorders
stats
group Id
EG000
num Affected
5
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Anaphylaxis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Anemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Anorexia
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Aspartate aminotransferase increased
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Constipation
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Dehydration
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Diarrhea
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Enterocolitis infectious
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Eye infection
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Febrile neutropenia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
93
group Id
EG001
num Affected
0
num At Risk
0
term
Headache

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Preserved source evidence · Not medical advice