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This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib + Gemcitabine | Experimental | Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles. |
|
| Gemcitabine | Active Comparator | Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | 150 mg po daily |
| |
| Gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. |
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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 |
|---|---|---|---|---|---|---|
| Auchenflower | 4066 | Australia | ||||
Total 17 participants were enrolled; however the data was available for 16 participants. One participant in the gemcitabine arm withdrew consent before receiving treatment.
A total of 17 chemo-naïve participants with Non-Small Cell Lung Cancer (NSCLC) Stage IIIB with pleural effusion or stage IV and a Eastern Cooperative Oncology Group performance status 2 (PS 2) were recruited. The study was conducted from 24 August 2007 to 14 February 2009 at 14 Centers in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine | Participants received Gemcitabine 1000 milligram per meter square (mg/m^2)/day, intravenously (IV) on Days 1, 8, 15 and every 4 weeks for 6 cycles |
| FG001 | Erlotinib + Gemcitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
As prescribed |
|
| Up to 2 years |
| Disease Control Rate | Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions. | Up to 2 years |
| Duration of Response | Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death. | Up to 2 years |
| Overall Survival | Overall survival was defined as the interval between the date of randomization to the date of death from any cause. | Up to 2 years |
| Mean Change in Pulse Rate From Baseline | Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value | Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15) |
| Mean Change in Blood Pressure From Baseline | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value. | Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15) |
| Mean Change in Body Temperature From Baseline | Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value. | Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15) |
| Chermside |
| 4032 |
| Australia |
| Footscray | 3011 | Australia |
| Greenslopes | 4120 | Australia |
| Lismore | 2480 | Australia |
| Melbourne | 3002 | Australia |
| Melbourne | 3084 | Australia |
| Parkville | 3052 | Australia |
| Randwick | 2031 | Australia |
| Richmond | 3121 | Australia |
| St Leonards | 2065 | Australia |
| Sydney | 2139 | Australia |
| Wodonga | 3690 | Australia |
| Wollongong | 2500 | Australia |
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
| COMPLETED |
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| NOT COMPLETED |
|
|
Intention-to-treat (ITT) population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine | Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles |
| BG001 | Erlotinib + Gemcitabine | Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were analyzed using the intention-to-treat (ITT) population. ITT included all randomized participants. | 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 | Progression Free Survival | Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first. | Per protocol (PP) population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death. | Posted | Median | 95% Confidence Interval | Week | Up to 2 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. | PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death. | Posted | Number | Percentage of participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate | Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions. | PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death. | Posted | Number | Percentage of participants | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death. | PP population included all randomized participants received at least one dose of study medication and had at least one post baseline tumor assessment or record of death. Participants available at the time of evaluation of duration of response were included in the analysis. | Posted | Mean | Standard Deviation | Week | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the interval between the date of randomization to the date of death from any cause. | PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death | Posted | Median | 95% Confidence Interval | Week | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Pulse Rate From Baseline | Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value | Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at baseline. | Posted | Mean | Standard Deviation | beats per minute | Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Blood Pressure From Baseline | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value. | Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at Baseline. | Posted | Mean | Standard Deviation | mm Hg | Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Body Temperature From Baseline | Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value. | Safety population included all participants who received at least one dose/infusion and had at least one safety assessment performed at baseline. | Posted | Mean | Standard Deviation | Fahrenheit | Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15) |
|
|
Up to 2 years
Adverse event is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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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 | Gemcitabine | Participants received Gemcitabine (1000 mg/m^2/day), IV on Days 1, 8, 15 of each 4 week cycle for 6 cycles | 5 | 8 | 7 | 8 | ||
| EG001 | Erlotinib + Gemcitabine | Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles | 6 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 11.1 | Systematic Assessment |
| |
| Recall phenomenon | Injury, poisoning and procedural complications | MedDRA version 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Oedema peripheral | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Pain | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Pyrexia | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Oedema peripheral | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Chills | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Feeling cold | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Influenza like illness | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Malaise | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Mucosal inflammation | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Pain | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Pyrexia | General disorders | MedDRA version 11.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Haemoglobin decreased | Investigations | MedDRA version 11.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 11.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 11.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 11.1 | Systematic Assessment |
| |
| Blood glucose fluctuation | Investigations | MedDRA version 11.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA version 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 11.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 11.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 11.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Penile swelling | Reproductive system and breast disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Deafness bilateral | Ear and labyrinth disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Cerebral hygroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.1 | 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 | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
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