TriangleNCT01121393 · OUTCOME
Objective Response (OR)
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 assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
What was measured
OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR. CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions. PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions. (Exact 95% Confidence interval by Clopper and Pearson.)
Analysis population: The randomised set.
Groups in this outcome
Afatinib 40 Milligram (mg)
Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
Gemcitabine / Cisplatin Chemotherapy
Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
| Group | Source count |
|---|---|
| Afatinib 40 Milligram (mg) | 242 |
| Gemcitabine / Cisplatin Chemotherapy | 122 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib 40 Milligram (mg) | 67.8 | Not reported | 61.5 | 73.6 | Not reported |
| Gemcitabine / Cisplatin Chemotherapy | 23.0 | Not reported | 15.8 | 31.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 4.522
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.679
- group Description
- A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 7.572
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 4.522
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.679
- group Description
- A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 7.572
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 61.5
- upper Limit
- 73.6
- value
- 67.8
- group Id
- OG001
- lower Limit
- 15.8
- upper Limit
- 31.4
- value
- 23.0
- denoms
- counts
- group Id
- OG000
- value
- 242
- group Id
- OG001
- value
- 122
- units
- Participants
- description
- OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR. CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions. PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions. (Exact 95% Confidence interval by Clopper and Pearson.)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
- id
- OG000
- title
- Afatinib 40 Milligram (mg)
- description
- Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
- id
- OG001
- title
- Gemcitabine / Cisplatin Chemotherapy
- param Type
- NUMBER
- population Description
- The randomised set.
- reporting Status
- POSTED
- time Frame
- Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
- title
- Objective Response (OR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice