TriangleNCT00085735 · OUTCOME
Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4
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 impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.
Analysis population: Eligible \& evaluable pts were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable(NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 eligible/evaluable pts. However some pts (28/22) weren't followed for at least 1-yr post-off tx (e.g., withdrew consent for FU or died), leaving 199 IFRT/215 PFRT pts.
Groups in this outcome
Involved Field Radiation (IFRT)
Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).
Posterior Fossa Radiation (PFRT)
Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
| Group | Source count |
|---|---|
| Involved Field Radiation (IFRT) | 199 |
| Posterior Fossa Radiation (PFRT) | 215 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Involved Field Radiation (IFRT) | 8 | Not reported | Not reported | Not reported | Not reported |
| Posterior Fossa Radiation (PFRT) | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 199
- group Id
- OG001
- value
- 215
- units
- Participants
- description
- Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.
- groups
- description
- Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).
- id
- OG000
- title
- Involved Field Radiation (IFRT)
- description
- Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
- id
- OG001
- title
- Posterior Fossa Radiation (PFRT)
- param Type
- NUMBER
- population Description
- Eligible \& evaluable pts were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable(NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 eligible/evaluable pts. However some pts (28/22) weren't followed for at least 1-yr post-off tx (e.g., withdrew consent for FU or died), leaving 199 IFRT/215 PFRT pts.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4
- 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