NCT00716976 · OUTCOME

Incidence of Hearing Loss

Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy · Source last updated 2023-11-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Patients
Interval / dispersion: Not reported
Time frame: 4 weeks after last dose of cisplatin

What was measured

Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.

Analysis population: 55 eligible patients enrolled on the observation Arm had complete audiometry data for evaluation; 49 eligible patients enrolled on the STS arm had complete data audiometry for evaluation.

Groups in this outcome

STS Arm (Sodium Thiosulfate Treatment)

Sodium thiosulfate treatment.

Observation Arm

No sodium thiosulfate treatment.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
STS Arm (Sodium Thiosulfate Treatment)	49
Observation Arm	55

Reported measurements

Source class 1

Values in Patients · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
STS Arm (Sodium Thiosulfate Treatment)	14	Not reported	Not reported	Not reported	Not reported
Observation Arm	31	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
14
group Id
OG001
value
31

denoms

counts
group Id
OG000
value
49
group Id
OG001
value
55
units
Participants

description

Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.

groups

description
Sodium thiosulfate treatment.
id
OG000
title
STS Arm (Sodium Thiosulfate Treatment)
description
No sodium thiosulfate treatment.
id
OG001
title
Observation Arm

param Type

NUMBER

population Description

55 eligible patients enrolled on the observation Arm had complete audiometry data for evaluation; 49 eligible patients enrolled on the STS arm had complete data audiometry for evaluation.

reporting Status

POSTED

time Frame

4 weeks after last dose of cisplatin

title

Incidence of Hearing Loss

type

PRIMARY

unit Of Measure

Patients

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

Preserved source evidence · Not medical advice