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This randomized parallel group study will assess the efficacy and safety of erlotinib [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
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| B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | 75 mg/m2 intravenously every 3 weeks for 4 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Free From Disease Progression or Death at 6 Months | According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression). | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progression-free Survival (PFS) was defined as the interval (in days) between the date of randomization and the first documentation of progressive disease or death from any cause. Participants alive and progression-free were considered as censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without post-baseline tumor assessment, but known to be alive, were censored at the time of randomization. PFS (days) = (Date of Event - Date of Randomization) + 1. PFS was assessed using the Kaplan-Meier method. Detailed definition of PD is provided in Outcome Measure 1. |
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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 |
|---|---|---|---|---|---|---|
| Lecce | Apulia | 73100 | Italy | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity. |
| FG001 | Docetaxel and Erlotinib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| erlotinib [Tarceva] |
| Drug |
150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter |
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| erlotinib [Tarceva] | Drug | 150 mg/day orally as monotherapy |
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| From randomization until progressive disease or death, assessed up to 18 months |
| Overall Survival (OS) | Overall survival (OS) was defined as the interval (in days) between the date of randomization and death from any cause. Participants alive at the time of the analysis were censored at the date they were last known to be alive. OS was assessed using the Kaplan-Meier method. | From randomization until death, assessed up to 18 months |
| Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) | Best overall response (complete response [CR]/partial response [PR]) was defined as the best response recorded from the start of the treatment until disease progression (PD). Best response in this trial was defined as the best response observed at any post-treatment visits. According to RECIST Version 1.1, 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). No new lesions. PR was defined as 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. No new lesions. | From randomization until progressive disease or death, assessed up to 18 months |
| Percentage of Participants With Disease Control | Disease control was defined as PR, CR, or SD. Participants who did not achieve a CR or PR or SD were counted as non-responders in the analysis of disease control. According to RECIST Version 1.1, SD was defined as not qualifying for CR, PR, and PD. Detailed definitions of CR and PR are provided in Outcome Measure 4. | From randomization until progressive disease or death, assessed up to 18 months |
| Duration of Response (DoR) | Duration of response (DoR) was defined as the interval (in days) from first documentation of a response (CR/PR depending on which occurred first) to the date of the first documentation of disease progression or death from any cause. Participants presenting a response were considered as censored at the date of the last assessment with a documentation of non-progression. DoR (days) = (Date of PD/death - Date of CR/PR) + 1. Assessments were performed according to RECIST Version 1.1. DoR was assessed using the Kaplan-Meier method. Detailed definitions of CR and PR are provided in Outcome Measure 4. | From randomization until progressive disease or death, assessed up to 18 months |
| San Giovanni Rotondo |
| Apulia |
| 71013 |
| Italy |
| Avellino | Campania | 83100 | Italy |
| Naples | Campania | 80131 | Italy |
| Parma | Emilia-Romagna | 43100 | Italy |
| Aviano (PN) | Friuli Venezia Giulia | 33081 | Italy |
| Rome | Lazio | 00152 | Italy |
| Rome | Lazio | 00157 | Italy |
| Rome | Lazio | 00168 | Italy |
| Cremona | Lombardy | 26100 | Italy |
| Milan | Lombardy | 20142 | Italy |
| Monza | Lombardy | 20900 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Sondalo | Lombardy | 23039 | Italy |
| Province of Macerata | The Marches | 62100 | Italy |
| Lido di Camaiore | Tuscany | 55043 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Pontedera | Tuscany | 56025 | Italy |
| Treviso | Veneto | 31100 | Italy |
| Vicenza | Veneto | 36100 | Italy |
Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
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| COMPLETED |
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Full analysis set (FAS) included all randomized participants who received at least one dose of study medication. Participants were analyzed according to treatment received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity. |
| BG001 | Docetaxel and Erlotinib | Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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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 | Percentage of Participants Free From Disease Progression or Death at 6 Months | According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression). | FAS population | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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| Secondary | Progression-free Survival (PFS) | Progression-free Survival (PFS) was defined as the interval (in days) between the date of randomization and the first documentation of progressive disease or death from any cause. Participants alive and progression-free were considered as censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without post-baseline tumor assessment, but known to be alive, were censored at the time of randomization. PFS (days) = (Date of Event - Date of Randomization) + 1. PFS was assessed using the Kaplan-Meier method. Detailed definition of PD is provided in Outcome Measure 1. | FAS population | Posted | Median | 95% Confidence Interval | months | From randomization until progressive disease or death, assessed up to 18 months |
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| Secondary | Overall Survival (OS) | Overall survival (OS) was defined as the interval (in days) between the date of randomization and death from any cause. Participants alive at the time of the analysis were censored at the date they were last known to be alive. OS was assessed using the Kaplan-Meier method. | FAS population | Posted | Median | 95% Confidence Interval | months | From randomization until death, assessed up to 18 months |
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| Secondary | Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) | Best overall response (complete response [CR]/partial response [PR]) was defined as the best response recorded from the start of the treatment until disease progression (PD). Best response in this trial was defined as the best response observed at any post-treatment visits. According to RECIST Version 1.1, 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). No new lesions. PR was defined as 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. No new lesions. | FAS population | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until progressive disease or death, assessed up to 18 months |
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| Secondary | Percentage of Participants With Disease Control | Disease control was defined as PR, CR, or SD. Participants who did not achieve a CR or PR or SD were counted as non-responders in the analysis of disease control. According to RECIST Version 1.1, SD was defined as not qualifying for CR, PR, and PD. Detailed definitions of CR and PR are provided in Outcome Measure 4. | FAS population | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until progressive disease or death, assessed up to 18 months |
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| Secondary | Duration of Response (DoR) | Duration of response (DoR) was defined as the interval (in days) from first documentation of a response (CR/PR depending on which occurred first) to the date of the first documentation of disease progression or death from any cause. Participants presenting a response were considered as censored at the date of the last assessment with a documentation of non-progression. DoR (days) = (Date of PD/death - Date of CR/PR) + 1. Assessments were performed according to RECIST Version 1.1. DoR was assessed using the Kaplan-Meier method. Detailed definitions of CR and PR are provided in Outcome Measure 4. | FAS population. Here, number of participants analyzed signifies those participants who had a best overall response of CR or PR. | Posted | Median | 95% Confidence Interval | months | From randomization until progressive disease or death, assessed up to 18 months |
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Up to 18 months
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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 | Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity. | 15 | 36 | 32 | 36 | ||
| EG001 | Docetaxel and Erlotinib | Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity. | 10 | 37 | 35 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Device dislocation | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Performance status decreased | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Uncoded | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Angiopathy | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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