TriangleNCT01828099 · OUTCOME
Duration of Response (DOR) by BIRC Assessment
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 first documented response to first documented disease progression or death, assessed up to approximately 34 months
What was measured
DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by BIRC assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method.
Analysis population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by BIRC assessment.
Groups in this outcome
Ceritinib
Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
Chemotherapy
Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
| Group | Source count |
|---|---|
| Ceritinib | 137 |
| Chemotherapy | 50 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ceritinib | 23.9 | Not reported | 16.6 | NA | NA: not estimable due to an insufficient number of participants with events. |
| Chemotherapy | 11.1 | Not reported | 7.8 | 16.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- NA: not estimable due to an insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 16.6
- upper Limit
- NA
- value
- 23.9
- group Id
- OG001
- lower Limit
- 7.8
- upper Limit
- 16.4
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 50
- units
- Participants
- description
- DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by BIRC assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
- id
- OG000
- title
- Ceritinib
- description
- Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by BIRC assessment.
- reporting Status
- POSTED
- time Frame
- From first documented response to first documented disease progression or death, assessed up to approximately 34 months
- title
- Duration of Response (DOR) by BIRC Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice