TriangleNCT01828099 · OUTCOME
PFS by Investigator 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 the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 120 months
What was measured
PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by investigator assessment per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS 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.
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 | 189 |
| Chemotherapy | 187 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ceritinib | 16.8 | Not reported | 13.5 | 22.8 | Not reported |
| Chemotherapy | 7.2 | Not reported | 5.8 | 9.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.5
- upper Limit
- 22.8
- value
- 16.8
- group Id
- OG001
- lower Limit
- 5.8
- upper Limit
- 9.7
- value
- 7.2
- denoms
- counts
- group Id
- OG000
- value
- 189
- group Id
- OG001
- value
- 187
- units
- Participants
- description
- PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by investigator assessment per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS 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.
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 120 months
- title
- PFS by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice