NCT01121393 · OUTCOME
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC) · Source last updated 2018-12-14
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
- Not reported
- 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 last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status.
ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction;
1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work;
2. Ambulatory (\>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities;
3. Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours;
4. Completely disabled, cannot carry on any selfcare, totally confined to bed or chair;
5. Dead
Analysis population: The randomised set. Data only presented for patients with a baseline and at least one post-baseline assessment of ECOG status.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Afatinib 40 Milligram (mg) | 237 |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 110 |
|---|
Reported measurements
ECOG PS 0 (baseline) 0 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 11.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 21.8 | Not reported | Not reported | Not reported | Not reported |
|---|
ECOG PS 1 (baseline) 0 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 6.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 3.6 | Not reported | Not reported | Not reported | Not reported |
|---|
ECOG PS 0 (baseline) 1 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 8.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 14.5 | Not reported | Not reported | Not reported | Not reported |
|---|
ECOG PS 1 (baseline) 1 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 67.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 51.8 | Not reported | Not reported | Not reported | Not reported |
|---|
ECOG PS 0 (baseline) 2 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 0.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
ECOG PS 1 (baseline) 2 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 2.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 1.8 | Not reported | Not reported | Not reported | Not reported |
|---|
ECOG PS 0 (baseline) 3 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
ECOG PS 1 (baseline) 3 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 2.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 4.5 | Not reported | Not reported | Not reported | Not reported |
|---|
ECOG PS 0 (baseline) 4 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 0.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
ECOG PS 1 (baseline) 4 (last value)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib 40 Milligram (mg) | 1.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gemcitabine / Cisplatin Chemotherapy | 1.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11.4
- group Id
- OG001
- value
- 21.8
- title
- ECOG PS 0 (baseline) 0 (last value)
- categories
- measurements
- group Id
- OG000
- value
- 6.8
- group Id
- OG001
- value
- 3.6
- title
- ECOG PS 1 (baseline) 0 (last value)
- categories
- measurements
- group Id
- OG000
- value
- 8.0
- group Id
- OG001
- value
- 14.5
- title
- ECOG PS 0 (baseline) 1 (last value)
- categories
- measurements
- group Id
- OG000
- value
- 67.5
- group Id
- OG001
- value
- 51.8
- title
- ECOG PS 1 (baseline) 1 (last value)
- categories
- measurements
- group Id
- OG000
- value
- 0.4
- group Id
- OG001
- value
- 0.0
- title
- ECOG PS 0 (baseline) 2 (last value)
- categories
- measurements
- group Id
- OG000
- value
- 2.1
- group Id
- OG001
- value
- 1.8
- title
- ECOG PS 1 (baseline) 2 (last value)
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- ECOG PS 0 (baseline) 3 (last value)
- categories
- measurements
- group Id
- OG000
- value
- 2.1
- group Id
- OG001
- value
- 4.5
- title
- ECOG PS 1 (baseline) 3 (last value)
- categories
- measurements
- group Id
- OG000
- value
- 0.4
- group Id
- OG001
- value
- 0.0
- title
- ECOG PS 0 (baseline) 4 (last value)
- categories
- measurements
- group Id
- OG000
- value
- 1.3
- group Id
- OG001
- value
- 1.8
- title
- ECOG PS 1 (baseline) 4 (last value)
- denoms
- counts
- group Id
- OG000
- value
- 237
- group Id
- OG001
- value
- 110
- units
- Participants
- description
- The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status.
ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction;
1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work;
2. Ambulatory (\>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities;
3. Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours;
4. Completely disabled, cannot carry on any selfcare, totally confined to bed or chair;
5. Dead
- 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. Data only presented for patients with a baseline and at least one post-baseline assessment of ECOG status.
- 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 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle