TriangleNCT01828099 · OUTCOME
Duration of Intracranial Response (DOIR)
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 in the brain or death, assessed up to approximately 34 months
What was measured
DOIR is defined as the DOR based on lesions in brain (target, non-target lesions and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. 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.
Analysis population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable brain disease and who had a baseline and at least one post-baseline scan, and a confirmed intracranial CR or PR
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 | 16 |
| Chemotherapy | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ceritinib | 16.6 | Not reported | 8.1 | NA | NA: not estimable due to an insufficient number of participants with events. |
| Chemotherapy | NA | Not reported | 1.5 | NA | NA: not estimable due to an insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA: not estimable due to an insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 8.1
- upper Limit
- NA
- value
- 16.6
- comment
- NA: not estimable due to an insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- DOIR is defined as the DOR based on lesions in brain (target, non-target lesions and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. 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.
- 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 measurable brain disease and who had a baseline and at least one post-baseline scan, and a confirmed intracranial CR or PR
- reporting Status
- POSTED
- time Frame
- From first documented response to first documented disease progression in the brain or death, assessed up to approximately 34 months
- title
- Duration of Intracranial Response (DOIR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice