TriangleNCT01907100 · OUTCOME
Disease Control According to Modified RECIST- Investigator Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months
What was measured
Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST. Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part.
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 | 229 |
| Nintedanib | 229 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 92.6 | Not reported | 88.4 | 95.6 | Not reported |
| Nintedanib | 90.8 | Not reported | 86.3 | 94.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.55
- estimate Comment
- Odds ratio above 1 favours nintedanib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.7512
- p Value Comment
- one-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 0.79
- statistical Comment
- Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 0.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.55
- estimate Comment
- Odds ratio above 1 favours nintedanib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.7512
- p Value Comment
- one-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 0.79
- statistical Comment
- Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 88.4
- upper Limit
- 95.6
- value
- 92.6
- group Id
- OG001
- lower Limit
- 86.3
- upper Limit
- 94.2
- value
- 90.8
- denoms
- counts
- group Id
- OG000
- value
- 229
- group Id
- OG001
- value
- 229
- units
- Participants
- description
- Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST. Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- Randomised Set: This patient set included all randomized patients.
- reporting Status
- POSTED
- time Frame
- Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months
- title
- Disease Control According to Modified RECIST- Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice