TriangleNCT02853331 · OUTCOME
Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
What was measured
TTD was defined as time (in months) from the first dose of study treatment to the date of deterioration of FKSI-DRS Score. The FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. Deterioration was defined as a 3-point decrease (i.e. lower score) in symptom score and the time to true deterioration was the time to first onset of 3 or more decreases from baseline with confirmation under right-censoring rule (the last observation). The time to true deterioration as measured in months is presented.
Analysis population: All randomized participants who received at least 1 dose of study medication and completed at least 1 questionnaire assessment.
Groups in this outcome
Pembrolizumab + Axitinib
Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
Sunitinib
Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
| Group | Source count |
|---|---|
| Pembrolizumab + Axitinib | 395 |
| Sunitinib | 387 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Axitinib | NA | Not reported | 12.7 | NA | TTD median not reached by the time of the data cutoff (24-Aug-2018). For TTD upper limit, no deterioration reached by the time of last disease assessment. |
| Sunitinib | NA | Not reported | NA | NA | TTD median not reached by the time of the data cutoff (24-Aug-2018). For TTD lower and upper limit, no deterioration reached by the time of last disease assessment. |
Complete source fields
- classes
- categories
- measurements
- comment
- TTD median not reached by the time of the data cutoff (24-Aug-2018). For TTD upper limit, no deterioration reached by the time of last disease assessment.
- group Id
- OG000
- lower Limit
- 12.7
- upper Limit
- NA
- value
- NA
- comment
- TTD median not reached by the time of the data cutoff (24-Aug-2018). For TTD lower and upper limit, no deterioration reached by the time of last disease assessment.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 395
- group Id
- OG001
- value
- 387
- units
- Participants
- description
- TTD was defined as time (in months) from the first dose of study treatment to the date of deterioration of FKSI-DRS Score. The FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. Deterioration was defined as a 3-point decrease (i.e. lower score) in symptom score and the time to true deterioration was the time to first onset of 3 or more decreases from baseline with confirmation under right-censoring rule (the last observation). The time to true deterioration as measured in months is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
- id
- OG000
- title
- Pembrolizumab + Axitinib
- description
- Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
- id
- OG001
- title
- Sunitinib
- param Type
- MEDIAN
- population Description
- All randomized participants who received at least 1 dose of study medication and completed at least 1 questionnaire assessment.
- reporting Status
- POSTED
- time Frame
- Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
- title
- Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice