NCT02097134 · ADVERSE EVENTS

Adverse events

Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma · Source last updated 2023-10-13

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: Up to 4 months
Other-event reporting threshold: 0%

The Other Adverse Events field contains Common Terminology Criteria for Adverse Events (CTCAEs) reported on protocol therapy, excluding those that were reported as Serious Adverse Events. The Serious Adverse Events field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Melphalan Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Melphalan: Given IA	2 / 14	3 / 14	0 / 14

Group identifiers: EG000: Melphalan

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
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Hypoxia

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
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Gastrointestinal disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
14
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Platelet count decreased

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
14
description
Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Melphalan: Given IA
id
EG000
other Num Affected
3
other Num At Risk
14
serious Num Affected
2
serious Num At Risk
14
title
Melphalan

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Gastrointestinal disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
14
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Platelet count decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Hypoxia

time Frame

Up to 4 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice