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This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib | Drug | 150 mg orally once a day for 12 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Progression or Death at 12 Months After Baseline | According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | 12 months |
| Progression-Free Survival (PFS) | PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method. | Up to 1 year after enrollment of the last participant (maximum up to 27 months) |
| Probability of Being Progression Free 12 Months After Baseline | According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died | Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months) | |
| Overall Survival (OS) | OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A | Naples | Campania | 80131 | Italy | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib 150 mg | Erlotinib 150 milligrams (mg) tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Safety population included all participants enrolled in the study who received at least 1 dose of treatment and had at least 1 safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib 150 mg | Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Disease Progression or Death at 12 Months After Baseline | According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Intent to treat (ITT) population included all participants enrolled in the study who received at least 1 dose of treatment. | Posted | Number | percentage of participants | 12 months |
|
Up to 1 year after enrollment of the last participant (maximum up to 27 months)
Safety population included all participants enrolled in the study who received at least one dose of treatment and had at least one safety assessment.
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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 | Erlotinib 150 mg | Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | MedDRA v14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months) |
| Percentage of Participants With a Response by Best Overall Response | Tumor response was assessed according to RECIST v1.1. Complete response (CR): complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR): greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease (SD): not qualifying for CR, PR, or PD. | Baseline up to disease progression or end of study (up to 12 Months) |
| Percentage of Participants With Objective Response | Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented. | Baseline up to disease progression or end of study (up to 12 Months) |
| Percentage of Participants Achieving CR, PR, or SD as Best Overall Response | The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD. | Baseline up to disease progression or end of study (up to 12 Months) |
| Percentage of Participants With Primary and Secondary Resistance | Primary resistance: participants did not reach SD or PR or CR before going to PD. Secondary resistance: participants experienced PD after having reached SD or PR or CR at least once. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Baseline up to disease progression (up to 12 Months) |
| Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type | EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas). | Baseline, At progression of disease (up to 12 Months) |
| Ospedale Bellaria; U.O. Oncologia Medica |
| Bologna |
| Emilia-Romagna |
| 40133 |
| Italy |
| A.O. Universitaria Policlinico Di Modena; Ematologia | Modena | Emilia-Romagna | 41100 | Italy |
| Istituto Regina Elena; Oncologia Medica A | Rome | Lazio | 00168 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia | Rozzano | Lombardy | 20089 | Italy |
| Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica | Catania | Sicily | 95122 | Italy |
| Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1 | Palermo | Sicily | 90127 | Italy |
| A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii | Pisa | Tuscany | 56124 | Italy |
| Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica | Perugia | Umbria | 06156 | Italy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants Who Died | ITT population. | Posted | Number | percentage of participants | Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months) |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method. | ITT population. | Posted | Mean | Standard Error | months | Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months) |
|
|
|
| Secondary | Percentage of Participants With a Response by Best Overall Response | Tumor response was assessed according to RECIST v1.1. Complete response (CR): complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR): greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease (SD): not qualifying for CR, PR, or PD. | ITT population. | Posted | Number | percentage of participants | Baseline up to disease progression or end of study (up to 12 Months) |
|
|
|
| Secondary | Percentage of Participants With Objective Response | Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to disease progression or end of study (up to 12 Months) |
|
|
|
| Primary | Progression-Free Survival (PFS) | PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method. | ITT population. | Posted | Median | 90% Confidence Interval | months | Up to 1 year after enrollment of the last participant (maximum up to 27 months) |
|
|
|
| Primary | Probability of Being Progression Free 12 Months After Baseline | According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | ITT population. | Posted | Mean | Standard Error | probability of being progression-free | 12 months |
|
|
|
| Secondary | Percentage of Participants Achieving CR, PR, or SD as Best Overall Response | The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to disease progression or end of study (up to 12 Months) |
|
|
|
| Secondary | Percentage of Participants With Primary and Secondary Resistance | Primary resistance: participants did not reach SD or PR or CR before going to PD. Secondary resistance: participants experienced PD after having reached SD or PR or CR at least once. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had a documented PD response during the study period. | Posted | Number | percentage of participants | Baseline up to disease progression (up to 12 Months) |
|
|
|
| Secondary | Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type | EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas). | Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had samples for EGFR mutation. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point. | Posted | Number | percentage of participants | Baseline, At progression of disease (up to 12 Months) |
|
|
|
| 10 |
| 50 |
| 46 |
| 50 |
| Dysphagia | Gastrointestinal disorders | MedDRA v14.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA v14.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v14.0 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA v14.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v14.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA v14.0 | Systematic Assessment |
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| Hemiplegia | Nervous system disorders | MedDRA v14.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA v14.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Jugular vein thrombosis | Vascular disorders | MedDRA v14.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA v14.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA v14.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA v14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v14.0 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA v14.0 | Systematic Assessment |
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| Contrast media reaction | Injury, poisoning and procedural complications | MedDRA v14.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA v14.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v14.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA v14.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA v14.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Systematic Assessment |
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| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Measurements |
|---|
|
| PD |
|
| Not estimated |
|
| Title | Measurements |
|---|---|
|
| Baseline: EGFR21 Codon L585R Mutation (n=45) |
|
| At PD: EGFR18 Mutation (n=18) |
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| At PD: EGFR19 Codon Deletion Mutation (n=18) |
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| At PD: EGFR20 Codon T790M Mutation (n=18) |
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| At PD: EGFR21 Codon L585R Mutation (n=18) |
|