TriangleNCT01523587 · OUTCOME
Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1
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
- First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
What was measured
Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Analysis population: Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment.
Groups in this outcome
Afatinib
Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
Erlotinib
Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
| Group | Source count |
|---|---|
| Afatinib | 398 |
| Erlotinib | 397 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib | 2.63 | Not reported | 2.00 | 2.86 | Not reported |
| Erlotinib | 1.94 | Not reported | 1.87 | 2.10 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.693
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.956
- group Description
- A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0103
- p Value Comment
- P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.814
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.693
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.956
- group Description
- A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0103
- p Value Comment
- P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.814
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.00
- upper Limit
- 2.86
- value
- 2.63
- group Id
- OG001
- lower Limit
- 1.87
- upper Limit
- 2.10
- value
- 1.94
- denoms
- counts
- group Id
- OG000
- value
- 398
- group Id
- OG001
- value
- 397
- units
- Participants
- description
- Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
- id
- OG000
- title
- Afatinib
- description
- Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
- id
- OG001
- title
- Erlotinib
- param Type
- MEDIAN
- population Description
- Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment.
- reporting Status
- POSTED
- time Frame
- First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
- title
- Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice