TriangleNCT00085735 · OUTCOME
Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of pts with g3+ hearing loss
- Interval / dispersion
- Not reported
- Time frame
- Up to 3 years
What was measured
Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used.
Analysis population: Only eligible \& evaluable pts 3-7 years of age are included since only younger pts were randomized to either LD or SD CSI. 11 and 8 LDCSI and SDCSI pts respectively were not evaluable due to anaplastic disease or excess residual/disseminated disease, leaving 116 vs 110 patients for this analysis.
Groups in this outcome
Low-dose Craniospinal Radiation (LDSCI)
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
Standard-dose Craniospinal Radiation (SDCSI)
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
| Group | Source count |
|---|---|
| Low-dose Craniospinal Radiation (LDSCI) | 116 |
| Standard-dose Craniospinal Radiation (SDCSI) | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-dose Craniospinal Radiation (LDSCI) | 11 | Not reported | Not reported | Not reported | Not reported |
| Standard-dose Craniospinal Radiation (SDCSI) | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 110
- units
- Participants
- description
- Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used.
- groups
- description
- Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
- id
- OG000
- title
- Low-dose Craniospinal Radiation (LDSCI)
- description
- Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
- id
- OG001
- title
- Standard-dose Craniospinal Radiation (SDCSI)
- param Type
- NUMBER
- population Description
- Only eligible \& evaluable pts 3-7 years of age are included since only younger pts were randomized to either LD or SD CSI. 11 and 8 LDCSI and SDCSI pts respectively were not evaluable due to anaplastic disease or excess residual/disseminated disease, leaving 116 vs 110 patients for this analysis.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4
- type
- SECONDARY
- unit Of Measure
- Percentage of pts with g3+ hearing loss
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice