TriangleNCT02990468 · OUTCOME
Incidence of Radiation-induced Xerostomia by Clinician Scoring
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- 6 months
What was measured
Xerostomia will be assessed using Maximum Xerostomia Clinical Score Common Terminology Criteria for Adverse Events (CTCAE) 4.03. Scores range from 0 to 5 with 0 being no xerostomia and 5 being the worst. Mean maximum xerostomia grade of patients assessed is reported.
Analysis population: One subject in group 3 did not complete follow up and was excluded from the analysis (a score of 0 representing no xerostomia)
Groups in this outcome
Phase 1: Group 1
Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
Phase 1: Group II
Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
Phase 2: Group III
Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
| Group | Source count |
|---|---|
| Phase 1: Group 1 | 3 |
| Phase 1: Group II | 3 |
| Phase 2: Group III | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Group 1 | 1 | 0 | Not reported | Not reported | Not reported |
| Phase 1: Group II | 1.33 | 0.27 | Not reported | Not reported | Not reported |
| Phase 2: Group III | 1.29 | 0.13 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 1
- group Id
- OG001
- spread
- 0.27
- value
- 1.33
- group Id
- OG002
- spread
- 0.13
- value
- 1.29
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 22
- units
- Participants
- description
- Xerostomia will be assessed using Maximum Xerostomia Clinical Score Common Terminology Criteria for Adverse Events (CTCAE) 4.03. Scores range from 0 to 5 with 0 being no xerostomia and 5 being the worst. Mean maximum xerostomia grade of patients assessed is reported.
- dispersion Type
- Standard Error
- groups
- description
- Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
- id
- OG000
- title
- Phase 1: Group 1
- description
- Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
- id
- OG001
- title
- Phase 1: Group II
- description
- Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
- id
- OG002
- title
- Phase 2: Group III
- param Type
- MEAN
- population Description
- One subject in group 3 did not complete follow up and was excluded from the analysis (a score of 0 representing no xerostomia)
- reporting Status
- POSTED
- time Frame
- 6 months
- title
- Incidence of Radiation-induced Xerostomia by Clinician Scoring
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice