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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021120-96 |
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This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib [Tarceva] | Drug | 150 mg daily, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Tested Positive for EGFR Mutations | All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations. | 14 days |
| Percentage of Participants With EGFR Mutations by Subgroup | Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history. | 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Response by Best Objective Tumor Response | Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1". Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
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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 |
|---|---|---|---|---|---|---|
| Belfast | BT47 6SB | United Kingdom | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-small-cell Lung Cancer (NSCLC) Group | During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. |
| FG001 | Erlotinib 150 Milligrams Per Day (mg/Day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Diagnostic Phase |
|
Not provided
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Not provided
Not provided
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| Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months |
| Probability of Being Alive and Free of Progression by Timepoint | Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method. | Months 0, 3, 6, 9, 12, 15, and 18 |
| Survival Time in Months | Duration of time in months from Screening until Death due to any cause. | Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
| Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument | The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement. | Screening, Baseline and Final or Withdrawal Visit up to 34 months |
| Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed. | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
| Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself. | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
| Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities. | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
| Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort. | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
| Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed. | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
| Belfast |
| BT9 7AB |
| United Kingdom |
| Bradford | BD9 6RJ | United Kingdom |
| Brighton | BN2 5BE | United Kingdom |
| Chelsmford | CM1 7ET | United Kingdom |
| Colchester | C03 3NB | United Kingdom |
| Dudley | DY1 2HQ | United Kingdom |
| Glasgow | G12 0YN | United Kingdom |
| Grimsby | DN33 2BA | United Kingdom |
| London | DD1 9SY | United Kingdom |
| London | N18 1QX | United Kingdom |
| London | NW1 2PG | United Kingdom |
| London | NW3 2QG | United Kingdom |
| London | SW17 0QT | United Kingdom |
| London | W6 8RF | United Kingdom |
| Newtownards | BT16 1RH | United Kingdom |
| Portadown | BT63 5QQ | United Kingdom |
| Rhyl | LL18 5UJ | United Kingdom |
| Sutton in Ashfield | NG17 4JL | United Kingdom |
| Truro | TR1 3LJ | United Kingdom |
| Westcliffe-on-sea | SS0 0RY | United Kingdom |
| York | BD20 6TD | United Kingdom |
During the Treatment Phase participants found to have a tumour with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until progressive disease (PD), death, unacceptable toxicity or withdrawal of consent. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Phase |
|
|
Diagnostic population: All participants newly diagnosed with recurrent or metastatic NSCLC who entered the study and signed the consent form were included in this population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NSCLC Group | During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations. |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Who Tested Positive for EGFR Mutations | All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations. | Diagnostic population; Only participants who were tested for EGFR mutations were included in the analysis. | Posted | Number | percentage of participants | 14 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response by Best Objective Tumor Response | Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1". Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Intention-to-treat (ITT) population: All participants in the target population who were eligible for treatment and who actually received one dose of treatment. | Posted | Number | percentage of participants | Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months |
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants With EGFR Mutations by Subgroup | Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history. | Only participants with a valid EGFR mutations test result were included in the analysis. | Posted | Number | percentage of participants | 14 Days |
|
| |||||||||||||||||||||||||||
| Secondary | Probability of Being Alive and Free of Progression by Timepoint | Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method. | ITT population | Posted | Number | 95% Confidence Interval | probability of being alive | Months 0, 3, 6, 9, 12, 15, and 18 |
|
| ||||||||||||||||||||||||||
| Secondary | Survival Time in Months | Duration of time in months from Screening until Death due to any cause. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument | The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement. | ITT population; number (n) = number of participants analyzed for the given parameter at the specified visit. | Posted | Mean | Standard Deviation | mm | Screening, Baseline and Final or Withdrawal Visit up to 34 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed. | ITT population; n = number of participants analyzed at for the given parameter at the specified visit. | Posted | Number | percentage of participants | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself. | ITT population; n = number of participants analyzed for the given parameter at the specified visit. | Posted | Number | percentage of participants | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities. | ITT population; n = number of participants analyzed for the given parameter at the specified visit. | Posted | Number | percentage of participants | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort. | ITT population; n = number of participants analyzed for the given parameter at the specified visit. | Posted | Number | percentage of participants | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed. | ITT population; n = number of participants analyzed for the given parameter at the specified visit. | Posted | Number | percentage of participants | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months |
|
|
Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
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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/Day | During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent. | 16 | 41 | 40 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Withdrawal by Subject |
|
| Adverse Event |
|
| Unknown reason |
|
| Units | Counts |
|---|---|
| Participants |
|
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|
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|
|
|
|
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