TriangleNCT04541355 · OUTCOME
Number of Participants Reporting Tinnitus by Severity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 18 weeks
What was measured
The frequency of tinnitus will be measured by participants' worst level response at any time point on the PRO-CTCAE® question "In the last 7 days, what was the severity of ringing in your ears at its worst?". Item responses were categorized as 'None', 'Mild', 'Moderate', 'Severe', and 'Very Severe'.
Groups in this outcome
Cisplatin, Radiotherapy, STS
Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Cisplatin, Radiotherapy, STS | 16 |
Reported measurements
None
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cisplatin, Radiotherapy, STS | 4 | Not reported | Not reported | Not reported | Not reported |
Mild
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cisplatin, Radiotherapy, STS | 7 | Not reported | Not reported | Not reported | Not reported |
Moderate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cisplatin, Radiotherapy, STS | 4 | Not reported | Not reported | Not reported | Not reported |
Severe
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cisplatin, Radiotherapy, STS | 1 | Not reported | Not reported | Not reported | Not reported |
Very Severe
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cisplatin, Radiotherapy, STS | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- None
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- Mild
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- Moderate
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Severe
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Very Severe
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- The frequency of tinnitus will be measured by participants' worst level response at any time point on the PRO-CTCAE® question "In the last 7 days, what was the severity of ringing in your ears at its worst?". Item responses were categorized as 'None', 'Mild', 'Moderate', 'Severe', and 'Very Severe'.
- groups
- description
- Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Cisplatin, Radiotherapy, STS
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 18 weeks
- title
- Number of Participants Reporting Tinnitus by Severity
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice