TriangleNCT01891344 · OUTCOME
Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
What was measured
The primary efficacy endpoint of PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST (Response Evaluation Criteria in Solid Tumors), as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Analysis population: Safety population by HRD subgroups: Consists of all Part 1 patients who received at least one dose of rucaparib.
Groups in this outcome
Part 1: tBRCA
Patients with a deleterious BRCA mutation detected in their tumor.
Part 1: Non-tBRCA LOH+
Patients without a BRCA mutation in their tumor, but have high LOH.
Part 1: Non-tBRCA LOH-
Patients without a BRCA mutation in their tumor, but have low LOH.
Part 1: Non-tBRCA LOH Unknown
Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
| Group | Source count |
|---|---|
| Part 1: tBRCA | 40 |
| Part 1: Non-tBRCA LOH+ | 82 |
| Part 1: Non-tBRCA LOH- | 70 |
| Part 1: Non-tBRCA LOH Unknown | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: tBRCA | 388 | Not reported | 273 | 448 | Not reported |
| Part 1: Non-tBRCA LOH+ | 174 | Not reported | 158 | 231 | Not reported |
| Part 1: Non-tBRCA LOH- | 160 | Not reported | 110 | 188 | Not reported |
| Part 1: Non-tBRCA LOH Unknown | 223 | Not reported | 55 | 499 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.170
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.437
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 0.273
- ci Lower Limit
- 0.428
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.871
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 0.610
Complete source fields
- analyses
- ci Lower Limit
- 0.170
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.437
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 0.273
- ci Lower Limit
- 0.428
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.871
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 0.610
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 273
- upper Limit
- 448
- value
- 388
- group Id
- OG001
- lower Limit
- 158
- upper Limit
- 231
- value
- 174
- group Id
- OG002
- lower Limit
- 110
- upper Limit
- 188
- value
- 160
- group Id
- OG003
- lower Limit
- 55
- upper Limit
- 499
- value
- 223
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 82
- group Id
- OG002
- value
- 70
- group Id
- OG003
- value
- 12
- units
- Participants
- description
- The primary efficacy endpoint of PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST (Response Evaluation Criteria in Solid Tumors), as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with a deleterious BRCA mutation detected in their tumor.
- id
- OG000
- title
- Part 1: tBRCA
- description
- Patients without a BRCA mutation in their tumor, but have high LOH.
- id
- OG001
- title
- Part 1: Non-tBRCA LOH+
- description
- Patients without a BRCA mutation in their tumor, but have low LOH.
- id
- OG002
- title
- Part 1: Non-tBRCA LOH-
- description
- Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
- id
- OG003
- title
- Part 1: Non-tBRCA LOH Unknown
- param Type
- MEDIAN
- population Description
- Safety population by HRD subgroups: Consists of all Part 1 patients who received at least one dose of rucaparib.
- reporting Status
- POSTED
- time Frame
- Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
- title
- Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study)
- type
- PRIMARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice