TriangleNCT02709512 · OUTCOME
Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- approximately 18 months
What was measured
Objective Response Rate is calculated as the proportion of subjects whose best tumor response from all post-baseline tumor assessments is complete response (CR) or partial response (PR). The best tumor response is the best response recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation. To test Objective Response Rate significance, a Relative Risk Ratio (ADI-PEG 20 / Placebo) was calculated as the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology (biphasic versus sarcomatoid).
Groups in this outcome
Drug: ADI-PEG 20 Plus Pem Platinum
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous ADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication
Drug: Placebo Plus Pem Platinum
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous Placebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication
| Group | Source count |
|---|---|
| Drug: ADI-PEG 20 Plus Pem Platinum | 87 |
| Drug: Placebo Plus Pem Platinum | 89 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Drug: ADI-PEG 20 Plus Pem Platinum | 12 | Not reported | Not reported | Not reported | Not reported |
| Drug: Placebo Plus Pem Platinum | 12 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.11
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Relative Risk Ratio (ADIPemPlatinum/PlaceboPemPlatinum) is the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology. A relative risk ratio greater than one is favorable to ADIPemPlatinum.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9489
- param Type
- Risk Ratio (RR)
- param Value
- 1.02
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.11
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Relative Risk Ratio (ADIPemPlatinum/PlaceboPemPlatinum) is the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology. A relative risk ratio greater than one is favorable to ADIPemPlatinum.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9489
- param Type
- Risk Ratio (RR)
- param Value
- 1.02
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 89
- units
- Participants
- description
- Objective Response Rate is calculated as the proportion of subjects whose best tumor response from all post-baseline tumor assessments is complete response (CR) or partial response (PR). The best tumor response is the best response recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation. To test Objective Response Rate significance, a Relative Risk Ratio (ADI-PEG 20 / Placebo) was calculated as the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology (biphasic versus sarcomatoid).
- groups
- description
- Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous ADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication
- id
- OG000
- title
- Drug: ADI-PEG 20 Plus Pem Platinum
- description
- Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous Placebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication
- id
- OG001
- title
- Drug: Placebo Plus Pem Platinum
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- approximately 18 months
- title
- Response Rate
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice