TriangleNCT01828099 · OUTCOME
Time to Response (TTR) by BIRC Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- Full Range
- Time frame
- From randomization to date of first documented response, up to approximately 34 months
What was measured
TTR is defined as the time from date of randomization to date of first documented response (CR or PR) measured by BIRC assessment per RECIST 1.1. 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. Patients who had not achieved a confirmed CR or PR were censored at the last adequate tumor assessment date when they had not had a PFS event or at maximum follow-up when they had had a PFS event.
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 | 6.14 | Not reported | 5.1 | 61.7 | Not reported |
| Chemotherapy | 13.36 | Not reported | 5.1 | 90.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.1
- upper Limit
- 61.7
- value
- 6.14
- group Id
- OG001
- lower Limit
- 5.1
- upper Limit
- 90.1
- value
- 13.36
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 50
- units
- Participants
- description
- TTR is defined as the time from date of randomization to date of first documented response (CR or PR) measured by BIRC assessment per RECIST 1.1. 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. Patients who had not achieved a confirmed CR or PR were censored at the last adequate tumor assessment date when they had not had a PFS event or at maximum follow-up when they had had a PFS event.
- dispersion Type
- Full Range
- 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 randomization to date of first documented response, up to approximately 34 months
- title
- Time to Response (TTR) by BIRC Assessment
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice