TriangleNCT01907100 · OUTCOME
Progression-Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)
What was measured
This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day.
Analysis population: Randomised Set: This patient set included all randomized patients.
Groups in this outcome
Placebo
Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Nintedanib
Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
| Group | Source count |
|---|---|
| Placebo | 272 |
| Nintedanib | 273 |
Reported measurements
Phase II
| Group | Source count |
|---|---|
| Placebo | 43 |
| Nintedanib | 44 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 5.72 | Not reported | 5.19 | 8.18 | Not reported |
| Nintedanib | 9.36 | Not reported | 5.55 | 12.65 | Not reported |
Phase III
| Group | Source count |
|---|---|
| Placebo | 229 |
| Nintedanib | 229 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 6.97 | Not reported | 5.42 | 9.00 | Not reported |
| Nintedanib | 6.77 | Not reported | 5.36 | 9.07 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.340
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.907
- estimate Comment
- Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).
- group Description
- Phase II Part
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0174
- param Type
- Hazard Ratio (HR)
- param Value
- 0.555
- statistical Method
- Proportional hazards mode
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.30
- estimate Comment
- Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.
- group Description
- Phase III part: A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo). If the hazard ratio is below 1 then it favours nintedanib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.5430
- p Value Comment
- one-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 1.01
- statistical Method
- Proportional hazards model
Complete source fields
- analyses
- ci Lower Limit
- 0.340
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.907
- estimate Comment
- Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).
- group Description
- Phase II Part
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0174
- param Type
- Hazard Ratio (HR)
- param Value
- 0.555
- statistical Method
- Proportional hazards mode
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.30
- estimate Comment
- Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.
- group Description
- Phase III part: A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo). If the hazard ratio is below 1 then it favours nintedanib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.5430
- p Value Comment
- one-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 1.01
- statistical Method
- Proportional hazards model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.19
- upper Limit
- 8.18
- value
- 5.72
- group Id
- OG001
- lower Limit
- 5.55
- upper Limit
- 12.65
- value
- 9.36
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 44
- units
- Participants
- title
- Phase II
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.42
- upper Limit
- 9.00
- value
- 6.97
- group Id
- OG001
- lower Limit
- 5.36
- upper Limit
- 9.07
- value
- 6.77
- denoms
- counts
- group Id
- OG000
- value
- 229
- group Id
- OG001
- value
- 229
- units
- Participants
- title
- Phase III
- denoms
- counts
- group Id
- OG000
- value
- 272
- group Id
- OG001
- value
- 273
- units
- Participants
- description
- This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
- id
- OG000
- title
- Placebo
- description
- Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
- id
- OG001
- title
- Nintedanib
- param Type
- MEDIAN
- population Description
- Randomised Set: This patient set included all randomized patients.
- reporting Status
- POSTED
- time Frame
- From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)
- title
- Progression-Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice