Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 13 of 13

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival (PFS) Time	Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression	Randomised set (RS)	Months.	MEDIAN
SECONDARY	Percentage of Patients With Objective Response (OR)	Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression	RS.	Percentage of patients with OR.	NUMBER
SECONDARY	Percentage of Participants With Disease Control (DC)	Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression	RS.	Percentage of participants with DC.	NUMBER
SECONDARY	Overall Survival (OS) Time	From randomisation to cut-off date (17MAR2017).	RS.	Months.	MEDIAN
SECONDARY	Tumour Shrinkage	Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression	RS. There were only 203 patients in the Afatinib 40 mg arm and 101 patients in the Pemetrexed/Cisplatin Chemotherapy with tumour measurements.	mm.	MEAN
SECONDARY	Change From Baseline in Body Weight	Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.	RS. Only patients with baseline and at least one post-baseline assessment were included.	Kg.	MEAN
SECONDARY	Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Throughout the trial until progression (every 3 weeks), up to 28 months.	RS. Only patients with baseline and at least one post-baseline assessment were included.	Participants	NUMBER
SECONDARY	Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing	Throughout the trial until progression (every 3 weeks).	RS.	Months.	MEDIAN
SECONDARY	HRQOL: Time to Deterioration in Dyspnoea	Throughout the trial until progression (every 3 weeks).	RS.	Months.	MEDIAN
SECONDARY	HRQOL: Time to Deterioration in Pain	Throughout the trial until progression (every 3 weeks).	RS.	Months.	MEDIAN
SECONDARY	Trough Plasma Concentrations of Afatinib at Day 22	Day 22.	Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.	ng/mL.	GEOMETRIC_MEAN
SECONDARY	Trough Plasma Concentrations of Afatinib at Day 29	Day 29.	Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.	ng/mL.	GEOMETRIC_MEAN
SECONDARY	Trough Plasma Concentrations of Afatinib at Day 43	Day 43.	Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.	ng/mL.	GEOMETRIC_MEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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GET https://conductscience.org/api/trials/v1/NCT00949650/outcomes

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