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This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSAâ„¢) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.
An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSAâ„¢) as First line Treatment in Caucasian Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | gefitinib 250mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | 250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (Investigator) | % of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements made at site by investigator. | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) (Investigator) | DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements made at site by investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) (Independent Central Review) | DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements of scans by central review. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haiyi Jiang | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Plovdiv | Bulgaria | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24263064 | Derived | Douillard JY, Ostoros G, Cobo M, Ciuleanu T, McCormack R, Webster A, Milenkova T. First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study. Br J Cancer. 2014 Jan 7;110(1):55-62. doi: 10.1038/bjc.2013.721. Epub 2013 Nov 21. |
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1060 Caucasian patients with locally advanced or metastatic NSCLC were screened, and 118 patients had activating sensitizing EGFR mutation eligible for the study (EGFR M+). 106 EGFR M+ patients received at least 1 dose of gefitinib. One patient had EGFR mutation not eligible for the study (EGFR M+I) and was started on gefitinib in error.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefitinib | Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
| Progression - Free Survival (PFS) (Investigator) | PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements made at site by investigator. | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
| Overall Survival (OS) | OS was defined as the time from first dose of gefitinib study treatment until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive. | Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death. |
| Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
| Objective Response Rate (ORR) (Independent Central Review)) | % of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements of scans by central review. | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
| Progression - Free Survival (PFS) (Independent Central Review) | PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements of scans by central review. | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
| Sofia |
| Bulgaria |
| Research Site | Stara Zagora | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Vratsa | Bulgaria |
| Research Site | Angers | France |
| Research Site | Saint-Herblain | France |
| Research Site | Athens | Greece |
| Research Site | Heraklion | Greece |
| Research Site | Larissa | Greece |
| Research Site | Thessaloniki | Greece |
| Research Site | Budapest | Hungary |
| Research Site | Deszk | Hungary |
| Research Site | Edelény | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Mosdós | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Ancona | Italy |
| Research Site | Carpi | Italy |
| Research Site | Livorno | Italy |
| Research Site | Perugia | Italy |
| Research Site | Oslo | Norway |
| Research Site | Stavanger | Norway |
| Research Site | Trondheim | Norway |
| Research Site | Gdansk | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lubin | Poland |
| Research Site | Olsztyn | Poland |
| Research Site | Otwock | Poland |
| Research Site | Szczecin | Poland |
| Research Site | Torun | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Coimbra | Portugal |
| Research Site | Lisbon | Portugal |
| Research Site | Porto | Portugal |
| Research Site | Vila Nova de Gaia | Portugal |
| Research Site | Brasov | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Cluj-Napoca | Romania |
| Research Site | Constanța | Romania |
| Research Site | Lleida | Spain |
| Research Site | Lugo | Spain |
| Research Site | Madrid | Spain |
| Research Site | Majadahonda | Spain |
| Research Site | Málaga | Spain |
| Research Site | Basel | Switzerland |
| Research Site | Chur | Switzerland |
| Research Site | Rapperswil-Jona | Switzerland |
| Research Site | Sursee | Switzerland |
| Research Site | Ankara | Turkey (Türkiye) |
| Research Site | Istanbul | Turkey (Türkiye) |
| Research Site | Izmir | Turkey (Türkiye) |
| Research Site | Aberdeen | United Kingdom |
| Research Site | Birmingham | United Kingdom |
| Research Site | Burnley | United Kingdom |
| Research Site | Cambridge | United Kingdom |
| Research Site | Dundee | United Kingdom |
| Research Site | Liverpool | United Kingdom |
| Research Site | Nottingham | United Kingdom |
| Research Site | Wolverhampton | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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This is a subset of all the screened patients who are found to be EGFR M+ and who have taken at least one dose of study medication (i.e. EGFR M+ patients are those who have activating sensitising EGFR mutation eligible for the study).
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefitinib | Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) (Investigator) | % of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements made at site by investigator. | Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib | Posted | Number | Percentage of Participants | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
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| |||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) (Investigator) | DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements made at site by investigator. | Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib | Posted | Number | Percentage of Participants | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Disease Control Rate (DCR) (Independent Central Review) | DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements of scans by central review. | Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib | Posted | Number | Percentage of Participants | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Objective Response Rate (ORR) (Independent Central Review)) | % of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements of scans by central review. | Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib | Posted | Number | Percentage of Participants | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
|
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| Secondary | Progression - Free Survival (PFS) (Investigator) | PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements made at site by investigator. | Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib | Posted | Median | 95% Confidence Interval | Months | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
|
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| Other Pre-specified | Progression - Free Survival (PFS) (Independent Central Review) | PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements of scans by central review. | Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib | Posted | Median | 95% Confidence Interval | Months | Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from first dose of gefitinib study treatment until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive. | Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib | Posted | Median | 95% Confidence Interval | Months | Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gefitinib 250 mg | 21 | 107 | 87 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA 15 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA 15 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 15 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 15 | Systematic Assessment |
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| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
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| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
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| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
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| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
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| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
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| DEMENTIA ALZHEIMER'S TYPE | Nervous system disorders | MedDRA 15 | Systematic Assessment |
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| HYPOAESTHESIA | Nervous system disorders | MedDRA 15 | Systematic Assessment |
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| SENILE DEMENTIA | Nervous system disorders | MedDRA 15 | Systematic Assessment |
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| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 15 | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
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| SKIN NECROSIS | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 15 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 15 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
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| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haiyi Jiang | AstraZeneca | +86 21 60302408 | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| > =75 Years |
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