TriangleNCT01121393 · OUTCOME
Change From Baseline in Body Weight
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- kilogram (kg)
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
What was measured
The change from baseline to the lowest and the last body weight recorded or during the the study.
Analysis population: The randomised set. Data only presented for a patient with a baseline and at least on post-baseline assessment of weight.
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) | 237 |
| Gemcitabine / Cisplatin Chemotherapy | 109 |
Reported measurements
Change from baseline at lowest value
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib 40 Milligram (mg) | -3.03 | 3.99 | Not reported | Not reported | Not reported |
| Gemcitabine / Cisplatin Chemotherapy | -1.52 | 3.65 | Not reported | Not reported | Not reported |
Change from baseline at last value
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib 40 Milligram (mg) | -0.76 | 4.79 | Not reported | Not reported | Not reported |
| Gemcitabine / Cisplatin Chemotherapy | 0.00 | 4.52 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.99
- value
- -3.03
- group Id
- OG001
- spread
- 3.65
- value
- -1.52
- title
- Change from baseline at lowest value
- categories
- measurements
- group Id
- OG000
- spread
- 4.79
- value
- -0.76
- group Id
- OG001
- spread
- 4.52
- value
- 0.00
- title
- Change from baseline at last value
- denoms
- counts
- group Id
- OG000
- value
- 237
- group Id
- OG001
- value
- 109
- units
- Participants
- description
- The change from baseline to the lowest and the last body weight recorded or during the the study.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- The randomised set. Data only presented for a patient with a baseline and at least on post-baseline assessment of weight.
- reporting Status
- POSTED
- time Frame
- Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
- title
- Change From Baseline in Body Weight
- type
- SECONDARY
- unit Of Measure
- kilogram (kg)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice