TriangleNCT01668784 · OUTCOME
Percentage of Participants With Disease-related Symptom Progression (DRSP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- from randomization up to disease progression or death (approximately up to 105 Months)
What was measured
Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.
Analysis population: All randomized participants; any participants that was randomized to any treatment group in the study.
Groups in this outcome
Nivolumab
Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
Everolimus
Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
| Group | Source count |
|---|---|
| Nivolumab | 410 |
| Everolimus | 411 |
Reported measurements
Disease-related Symptom Progression Rate (DRSPR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 44.6 | Not reported | 39.0 | 50.3 | Not reported |
| Everolimus | 54.6 | Not reported | 49.2 | 60.0 | Not reported |
DRSPR Including Death and Investigator Progression
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 95.5 | Not reported | 92.6 | 97.5 | Not reported |
| Everolimus | 99.4 | Not reported | 97.9 | 99.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.0
- upper Limit
- 50.3
- value
- 44.6
- group Id
- OG001
- lower Limit
- 49.2
- upper Limit
- 60.0
- value
- 54.6
- title
- Disease-related Symptom Progression Rate (DRSPR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 92.6
- upper Limit
- 97.5
- value
- 95.5
- group Id
- OG001
- lower Limit
- 97.9
- upper Limit
- 99.9
- value
- 99.4
- title
- DRSPR Including Death and Investigator Progression
- denoms
- counts
- group Id
- OG000
- value
- 410
- group Id
- OG001
- value
- 411
- units
- Participants
- description
- Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG001
- title
- Everolimus
- param Type
- NUMBER
- population Description
- All randomized participants; any participants that was randomized to any treatment group in the study.
- reporting Status
- POSTED
- time Frame
- from randomization up to disease progression or death (approximately up to 105 Months)
- title
- Percentage of Participants With Disease-related Symptom Progression (DRSP)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice