TriangleNCT02952534 · OUTCOME
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator
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
- Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
What was measured
A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.
Analysis population: Patients with a confirmed response in the Investigator Efficacy Population. The Investigator efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per the investigator. Note, there were no patients with confirmed response by investigator in the CDK12 arm.
Groups in this outcome
BRCA Mutation
Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
ATM Mutation
Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
CHEK2 Mutation
Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
Other Gene Mutation
Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
| Group | Source count |
|---|---|
| BRCA Mutation | 42 |
| ATM Mutation | 2 |
| CHEK2 Mutation | 1 |
| Other Gene Mutation | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BRCA Mutation | 6.6 | Not reported | 5.6 | 11.6 | Not reported |
| ATM Mutation | 7.5 | Not reported | 4.6 | 10.4 | Not reported |
| CHEK2 Mutation | 16.6 | Not reported | NA | NA | The median is the actual observed value for this participant. The confidence interval was not assessable due to insufficient number of participants with events. |
| Other Gene Mutation | 18.4 | Not reported | 10.1 | NA | The upper confidence interval was not assessable due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 11.6
- value
- 6.6
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- 10.4
- value
- 7.5
- comment
- The median is the actual observed value for this participant. The confidence interval was not assessable due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 16.6
- comment
- The upper confidence interval was not assessable due to insufficient number of participants with events.
- group Id
- OG003
- lower Limit
- 10.1
- upper Limit
- NA
- value
- 18.4
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 7
- units
- Participants
- description
- A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
- id
- OG000
- title
- BRCA Mutation
- description
- Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
- id
- OG001
- title
- ATM Mutation
- description
- Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
- id
- OG002
- title
- CHEK2 Mutation
- description
- Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
- id
- OG003
- title
- Other Gene Mutation
- param Type
- MEDIAN
- population Description
- Patients with a confirmed response in the Investigator Efficacy Population. The Investigator efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per the investigator. Note, there were no patients with confirmed response by investigator in the CDK12 arm.
- reporting Status
- POSTED
- time Frame
- Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
- title
- Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice