Trial Outcomes & Findings for First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia (NCT NCT00322452)
NCT ID: NCT00322452
Last Updated: 2013-11-07
Results Overview
PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.
COMPLETED
PHASE3
1329 participants
Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).
2013-11-07
Participant Flow
Males or females that had never smoked or were light ex-smokers, who had Stage IIIB or Stage IV adenocarcinoma of the lung and had not received any previous chemotherapy excluding non-platinum based adjuvant chemotherapy were randomised between 30 March 2006 and 9 October 2007. The study was carried out in Asian countries (including Japan \& China).
112 patients (out of 1329) failed screening and were not randomized, the majority of patients who failed screening did not comply with inclusion / exclusion criteria. Other reasons were: patient withdrew informed consent; patient lost to follow up. One patient was not randomized for 'other' (non-specified) reason.
Participant milestones
| Measure |
Gefitinib
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
609
|
608
|
|
Overall Study
COMPLETED
|
362
|
332
|
|
Overall Study
NOT COMPLETED
|
247
|
276
|
Reasons for withdrawal
| Measure |
Gefitinib
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Overall Study
Eligibility criteria not fulfilled
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
19
|
46
|
|
Overall Study
Death
|
223
|
227
|
Baseline Characteristics
First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia
Baseline characteristics by cohort
| Measure |
Gefitinib
n=609 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=608 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
Total
n=1217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57 Years
n=5 Participants
|
57 Years
n=7 Participants
|
57 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
484 Participants
n=5 Participants
|
481 Participants
n=7 Participants
|
965 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
603 Participants
n=5 Participants
|
606 Participants
n=7 Participants
|
1209 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (other than Chinese or Japanese)
|
179 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
314 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
618 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
114 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Smoking history
Never Smoker
|
571 Participants
n=5 Participants
|
569 Participants
n=7 Participants
|
1140 Participants
n=5 Participants
|
|
Smoking history
Light ex-smoker
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Smoking history
Ex-smoker (non-light)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
WHO performance status
0 (normal activity)
|
157 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
318 Participants
n=5 Participants
|
|
WHO performance status
1 (restricted activity)
|
391 Participants
n=5 Participants
|
382 Participants
n=7 Participants
|
773 Participants
n=5 Participants
|
|
WHO performance status
2 (in bed =< 50% of the time)
|
61 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).Population: Analysis was carried out on Intention-to-treat (ITT) population.
PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.
Outcome measures
| Measure |
Gefitinib
n=609 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=608 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Median Progression Free Survival (PFS) in Months
|
5.7 Months
Interval 5.4 to 6.8
|
5.8 Months
Interval 5.6 to 6.4
|
SECONDARY outcome
Timeframe: Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.Population: Analysis was carried out on Intention-to-treat (ITT) population.
Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. Median Overall Survival in months is presented here.
Outcome measures
| Measure |
Gefitinib
n=609 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=608 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)
|
18.8 Months
Interval 17.3 to 20.4
|
17.4 Months
Interval 16.2 to 18.7
|
SECONDARY outcome
Timeframe: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).Population: Analysis was carried out on Intention-to-treat (ITT) population.
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
Outcome measures
| Measure |
Gefitinib
n=609 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=608 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Objective Tumour Response Rate According to RECIST
|
262 Participants
|
196 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with a neutropenia event, identified from the lab data as a worsening in absolute neutrophil count from baseline to a CTC grade 3 or above which Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia
|
4 Participants
|
385 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with a thromboctyopenia event, identified from the lab data as a worsening in platelet count from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia
|
5 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with a leukopenia event, identified from the lab data as a worsening in white blood cell count from baseline to a CTC grade 3 or above. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia
|
1 Participants
|
202 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with an anaemia event, identified from the lab data as a worsening in haemoglobin from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia
|
11 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with a neurotoxicity event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Neurotoxicity
|
30 Participants
|
411 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with a rashes/acnes event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Rashes/Acnes
|
398 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with a diarrhoea event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Diarrhoea
|
274 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with a nausea event. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Nausea
|
74 Participants
|
260 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with a vomiting event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Vomiting
|
59 Participants
|
193 Participants
|
SECONDARY outcome
Timeframe: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxelPopulation: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Number of patients with an elevated liver transaminase event, identified from the lab data as a worsening in ALT or AST from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Outcome measures
| Measure |
Gefitinib
n=607 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases
|
57 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.Population: Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.
Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in FACT-L score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline \& at least 1 post-baseline visit
Outcome measures
| Measure |
Gefitinib
n=590 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=561 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire
|
283 Participants
|
229 Participants
|
SECONDARY outcome
Timeframe: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.Population: Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.
Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in TOI score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline \& at least 1 post-baseline visit
Outcome measures
| Measure |
Gefitinib
n=590 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=561 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire
|
274 Participants
|
184 Participants
|
SECONDARY outcome
Timeframe: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.Population: Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.
Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in LCS score (from baseline) of 2 or more, and there were no intervening visits showing a decrease from baseline of 2 or more. Includes all patients with QoL data at baseline \& at least 1 post-baseline visit
Outcome measures
| Measure |
Gefitinib
n=590 Participants
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=561 Participants
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire
|
304 Participants
|
272 Participants
|
Adverse Events
Gefitinib
Carboplatin/Paclitaxel
Serious adverse events
| Measure |
Gefitinib
n=607 participants at risk
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 participants at risk
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.16%
1/607
|
0.00%
0/589
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.16%
1/607
|
0.00%
0/589
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.16%
1/607
|
0.17%
1/589
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.00%
0/607
|
0.17%
1/589
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.16%
1/607
|
0.17%
1/589
|
|
Investigations
Alanine Aminotransferase Increased
|
0.16%
1/607
|
0.00%
0/589
|
|
Nervous system disorders
Altered State Of Consciousness
|
0.16%
1/607
|
0.17%
1/589
|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
1/607
|
0.85%
5/589
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/607
|
0.17%
1/589
|
|
Cardiac disorders
Angina Pectoris
|
0.16%
1/607
|
0.17%
1/589
|
|
Eye disorders
Angle Closure Glaucoma
|
0.00%
0/607
|
0.17%
1/589
|
|
Metabolism and nutrition disorders
Anorexia
|
0.49%
3/607
|
0.34%
2/589
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.16%
1/607
|
0.00%
0/589
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.33%
2/607
|
0.00%
0/589
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.16%
1/607
|
0.00%
0/589
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.16%
1/607
|
0.00%
0/589
|
|
Injury, poisoning and procedural complications
Brain Herniation
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Bronchitis
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Bronchopneumonia
|
0.16%
1/607
|
0.00%
0/589
|
|
Renal and urinary disorders
Calculus Urinary
|
0.33%
2/607
|
0.00%
0/589
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/607
|
0.17%
1/589
|
|
Cardiac disorders
Cardiac Failure
|
0.16%
1/607
|
0.00%
0/589
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Cellulitis
|
0.16%
1/607
|
0.00%
0/589
|
|
Nervous system disorders
Cerebral Artery Embolism
|
0.16%
1/607
|
0.00%
0/589
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.33%
2/607
|
0.00%
0/589
|
|
General disorders
Chest Pain
|
0.49%
3/607
|
0.00%
0/589
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/607
|
0.17%
1/589
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/607
|
0.17%
1/589
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/607
|
0.17%
1/589
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/607
|
0.17%
1/589
|
|
General disorders
Death
|
0.16%
1/607
|
0.17%
1/589
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.16%
1/607
|
0.00%
0/589
|
|
Metabolism and nutrition disorders
Dehydration
|
0.16%
1/607
|
0.00%
0/589
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.16%
1/607
|
0.00%
0/589
|
|
Gastrointestinal disorders
Diarrhoea
|
0.33%
2/607
|
0.34%
2/589
|
|
Nervous system disorders
Dizziness
|
0.33%
2/607
|
0.34%
2/589
|
|
Immune system disorders
Drug Hypersensitivity
|
0.16%
1/607
|
0.51%
3/589
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/607
|
0.17%
1/589
|
|
Reproductive system and breast disorders
Dysfunctional Uterine Bleeding
|
0.16%
1/607
|
0.00%
0/589
|
|
Gastrointestinal disorders
Dyspepsia
|
0.16%
1/607
|
0.00%
0/589
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
7/607
|
1.2%
7/589
|
|
Vascular disorders
Embolism
|
0.00%
0/607
|
0.17%
1/589
|
|
Nervous system disorders
Encephalitis
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Endocarditis
|
0.16%
1/607
|
0.00%
0/589
|
|
General disorders
Fatigue
|
0.00%
0/607
|
0.34%
2/589
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.16%
1/607
|
0.00%
0/589
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.16%
1/607
|
0.00%
0/589
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Gastroenteritis
|
0.33%
2/607
|
0.00%
0/589
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.33%
2/607
|
0.34%
2/589
|
|
Renal and urinary disorders
Haematuria
|
0.16%
1/607
|
0.00%
0/589
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/607
|
0.34%
2/589
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/607
|
0.17%
1/589
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.16%
1/607
|
0.00%
0/589
|
|
Nervous system disorders
Hemiplegia
|
0.16%
1/607
|
0.00%
0/589
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.16%
1/607
|
0.00%
0/589
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.66%
4/607
|
0.17%
1/589
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/607
|
0.17%
1/589
|
|
Renal and urinary disorders
Hydronephrosis
|
0.16%
1/607
|
0.00%
0/589
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.16%
1/607
|
0.00%
0/589
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.16%
1/607
|
0.00%
0/589
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.33%
2/607
|
0.17%
1/589
|
|
Vascular disorders
Hypotension
|
0.00%
0/607
|
0.17%
1/589
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/607
|
0.17%
1/589
|
|
Nervous system disorders
Iiird Nerve Paralysis
|
0.16%
1/607
|
0.00%
0/589
|
|
Gastrointestinal disorders
Ileus
|
0.16%
1/607
|
0.00%
0/589
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.99%
6/607
|
0.00%
0/589
|
|
Nervous system disorders
Ischaemic Stroke
|
0.16%
1/607
|
0.00%
0/589
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/607
|
0.17%
1/589
|
|
Nervous system disorders
Lacunar Infarction
|
0.16%
1/607
|
0.00%
0/589
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Granuloma
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.16%
1/607
|
0.17%
1/589
|
|
Infections and infestations
Lung Infection
|
0.00%
0/607
|
0.17%
1/589
|
|
General disorders
Malaise
|
0.00%
0/607
|
0.34%
2/589
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.16%
1/607
|
0.17%
1/589
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.33%
2/607
|
0.00%
0/589
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/607
|
0.17%
1/589
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/607
|
0.34%
2/589
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.16%
1/607
|
0.00%
0/589
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/607
|
1.7%
10/589
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/607
|
0.34%
2/589
|
|
Metabolism and nutrition disorders
Oral Intake Reduced
|
0.00%
0/607
|
0.17%
1/589
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.16%
1/607
|
0.00%
0/589
|
|
General disorders
Pain
|
0.00%
0/607
|
0.17%
1/589
|
|
Infections and infestations
Parotitis
|
0.00%
0/607
|
0.17%
1/589
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/607
|
0.34%
2/589
|
|
Cardiac disorders
Pericardial Effusion
|
0.16%
1/607
|
0.00%
0/589
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Pneumonia
|
1.5%
9/607
|
1.5%
9/589
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/607
|
0.17%
1/589
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/607
|
0.34%
2/589
|
|
Infections and infestations
Pseudomonal Sepsis
|
0.16%
1/607
|
0.00%
0/589
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.16%
1/607
|
0.00%
0/589
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.16%
1/607
|
0.17%
1/589
|
|
Eye disorders
Pupils Unequal
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Pyothorax
|
0.33%
2/607
|
0.00%
0/589
|
|
General disorders
Pyrexia
|
0.49%
3/607
|
0.34%
2/589
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/607
|
0.17%
1/589
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.16%
1/607
|
0.00%
0/589
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.16%
1/607
|
0.17%
1/589
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.33%
2/607
|
0.00%
0/589
|
|
Nervous system disorders
Sciatica
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Sepsis
|
0.33%
2/607
|
0.00%
0/589
|
|
Infections and infestations
Septic Shock
|
0.00%
0/607
|
0.51%
3/589
|
|
Cardiac disorders
Sinus Bradycardia
|
0.16%
1/607
|
0.00%
0/589
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.16%
1/607
|
0.00%
0/589
|
|
Nervous system disorders
Syncope Vasovagal
|
0.00%
0/607
|
0.17%
1/589
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.16%
1/607
|
0.00%
0/589
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/607
|
0.17%
1/589
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.16%
1/607
|
0.00%
0/589
|
|
Renal and urinary disorders
Urinary Retention
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Urinary Tract Infection
|
0.16%
1/607
|
0.00%
0/589
|
|
Infections and infestations
Urosepsis
|
0.00%
0/607
|
0.17%
1/589
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/607
|
0.17%
1/589
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/607
|
0.17%
1/589
|
|
Gastrointestinal disorders
Vomiting
|
0.33%
2/607
|
1.0%
6/589
|
Other adverse events
| Measure |
Gefitinib
n=607 participants at risk
Gefitinib 250mg daily
|
Carboplatin/Paclitaxel
n=589 participants at risk
Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
10.9%
66/607
|
0.68%
4/589
|
|
Investigations
Alanine Aminotransferase Increased
|
10.0%
61/607
|
5.3%
31/589
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.9%
42/607
|
58.2%
343/589
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
36/607
|
24.8%
146/589
|
|
Metabolism and nutrition disorders
Anorexia
|
15.2%
92/607
|
39.4%
232/589
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
22/607
|
19.0%
112/589
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.6%
52/607
|
3.2%
19/589
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
32/607
|
4.4%
26/589
|
|
Gastrointestinal disorders
Constipation
|
7.7%
47/607
|
28.9%
170/589
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
53/607
|
10.5%
62/589
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
5.8%
35/607
|
0.34%
2/589
|
|
Gastrointestinal disorders
Diarrhoea
|
45.0%
273/607
|
21.6%
127/589
|
|
Nervous system disorders
Dizziness
|
5.1%
31/607
|
5.9%
35/589
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
23.7%
144/607
|
2.9%
17/589
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
32/607
|
4.4%
26/589
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.8%
35/607
|
8.3%
49/589
|
|
General disorders
Fatigue
|
11.9%
72/607
|
36.8%
217/589
|
|
Investigations
Haemoglobin Decreased
|
0.16%
1/607
|
5.1%
30/589
|
|
Nervous system disorders
Headache
|
6.4%
39/607
|
7.3%
43/589
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
7.9%
48/607
|
3.9%
23/589
|
|
Nervous system disorders
Hypoaesthesia
|
1.2%
7/607
|
26.0%
153/589
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.3%
20/607
|
5.1%
30/589
|
|
Psychiatric disorders
Insomnia
|
11.9%
72/607
|
18.2%
107/589
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.82%
5/607
|
24.8%
146/589
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
24/607
|
31.6%
186/589
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
52/607
|
3.7%
22/589
|
|
Gastrointestinal disorders
Nausea
|
12.2%
74/607
|
44.0%
259/589
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.82%
5/607
|
16.5%
97/589
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.49%
3/607
|
37.0%
218/589
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/607
|
6.6%
39/589
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
4.0%
24/607
|
6.8%
40/589
|
|
Nervous system disorders
Paraesthesia
|
1.3%
8/607
|
5.1%
30/589
|
|
Infections and infestations
Paronychia
|
13.5%
82/607
|
0.00%
0/589
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
1.5%
9/607
|
23.9%
141/589
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
5.9%
36/607
|
4.8%
28/589
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.0%
103/607
|
11.7%
69/589
|
|
General disorders
Pyrexia
|
6.3%
38/607
|
9.5%
56/589
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.7%
308/607
|
20.4%
120/589
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
5.1%
31/607
|
0.17%
1/589
|
|
Gastrointestinal disorders
Stomatitis
|
12.9%
78/607
|
7.1%
42/589
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
7/607
|
11.9%
70/589
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.6%
34/607
|
3.9%
23/589
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
58/607
|
32.3%
190/589
|
|
Investigations
White Blood Cell Count Decreased
|
0.49%
3/607
|
8.8%
52/589
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator (PI) agrees to collaborate on the contents and formation of any publication and to pay due consideration to comments and opinions offered. AstraZeneca have 30 days for final manuscript review and may require that submission for publication be delayed in order to file patent applications.
- Publication restrictions are in place
Restriction type: OTHER