TriangleNCT02603432 · OUTCOME
Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores
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
- From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)
What was measured
NCCN-FACT FBlSI-18: an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging: 0=not at all to 4=very much. For items negatively framed, scores were reversed for analysis so that higher scores= good quality of life. DRS-P score: total 9 items, ranging from 0=severely symptomatic to 36= asymptomatic. Higher scores=better functioning or lower symptom burden. TTD: time from randomization to first time participant's score showed 3 point or greater decrease from baseline in FBlSI-DRS-P subscale for 2 consecutive assessments.
Analysis population: The full analysis set included all randomized participants.
Groups in this outcome
Avelumab + Best Supportive Care (BSC)
Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
Best Supportive Care
As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
| Group | Source count |
|---|---|
| Avelumab + Best Supportive Care (BSC) | 350 |
| Best Supportive Care | 350 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab + Best Supportive Care (BSC) | NA | Not reported | 13.9 | NA | Median and upper limit of 95% CI were not estimable due to the small number of events. |
| Best Supportive Care | 13.8 | Not reported | 12.9 | NA | The upper limit of 95% CI was not estimable due to the small number of events. |
Source statistical analyses
- ci Lower Limit
- 0.901
- ci Num Sides
- ONE_SIDED
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9130
- param Type
- Cox Proportional Hazard
- param Value
- 1.26
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.901
- ci Num Sides
- ONE_SIDED
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9130
- param Type
- Cox Proportional Hazard
- param Value
- 1.26
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median and upper limit of 95% CI were not estimable due to the small number of events.
- group Id
- OG000
- lower Limit
- 13.9
- upper Limit
- NA
- value
- NA
- comment
- The upper limit of 95% CI was not estimable due to the small number of events.
- group Id
- OG001
- lower Limit
- 12.9
- upper Limit
- NA
- value
- 13.8
- denoms
- counts
- group Id
- OG000
- value
- 350
- group Id
- OG001
- value
- 350
- units
- Participants
- description
- NCCN-FACT FBlSI-18: an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging: 0=not at all to 4=very much. For items negatively framed, scores were reversed for analysis so that higher scores= good quality of life. DRS-P score: total 9 items, ranging from 0=severely symptomatic to 36= asymptomatic. Higher scores=better functioning or lower symptom burden. TTD: time from randomization to first time participant's score showed 3 point or greater decrease from baseline in FBlSI-DRS-P subscale for 2 consecutive assessments.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
- id
- OG000
- title
- Avelumab + Best Supportive Care (BSC)
- description
- As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
- id
- OG001
- title
- Best Supportive Care
- param Type
- MEDIAN
- population Description
- The full analysis set included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)
- title
- Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice