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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003738-40 | EudraCT Number |
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This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. 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 | Experimental | Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death. |
|
| Placebo | Placebo Comparator | Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Participants received erlotinib 150 mg tablet orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method. | From the time of randomization until progression of disease or death (up to 30 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Overall Response Rate | Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions. |
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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 |
|---|---|---|---|---|---|---|
| Kogarah | New South Wales | 2217 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24827134 | Derived | Propper D, Davidenko I, Bridgewater J, Kupcinskas L, Fittipaldo A, Hillenbach C, Klughammer B, Ducreux M. Phase II, randomized, biomarker identification trial (MARK) for erlotinib in patients with advanced pancreatic carcinoma. Ann Oncol. 2014 Jul;25(7):1384-1390. doi: 10.1093/annonc/mdu176. Epub 2014 May 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Participants received placebo matching to erlotinib 150 mg tablet orally once daily. |
|
| From the time of randomization until progression of disease or death (up to 30 months) |
| Percentage of Participants With Disease Control Rate (DCR) | Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. | Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months) |
| Overall Survival | Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death. | From the time of randomization until or death (up to 30 months) |
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. | Up to 28 days after discontinuation of study drug (up to 30 months) |
| St Leonards |
| New South Wales |
| 2065 |
| Australia |
| Sydney | New South Wales | 2076 | Australia |
| Box Hill | Victoria | 3128 | Australia |
| Salvador, Bahia | Estado de Bahia | 40170-380 | Brazil |
| Belo Horizonte | Minas Gerais | 30110-0090 | Brazil |
| Curitiba | Paraná | 81520-060 | Brazil |
| Ijuà | Rio Grande do Sul | 98700-000 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90430-090 | Brazil |
| Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Jaú | São Paulo | 17210-080 | Brazil |
| São Paulo | São Paulo | 01246-000 | Brazil |
| São Paulo | São Paulo | 05652-000 | Brazil |
| Gabrovo | 5300 | Bulgaria |
| Pleven | 5800 | Bulgaria |
| Plovdiv | 4004 | Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1431 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Vratsa | 3000 | Bulgaria |
| Zagreb | 10000 | Croatia |
| Bochum | 44791 | Germany |
| Cologne | 50937 | Germany |
| Dresden | 01307 | Germany |
| Esslingen am Neckar | 73730 | Germany |
| Greifswald | 17489 | Germany |
| Hamburg | 20148 | Germany |
| Saarbrücken | 66113 | Germany |
| Ulm | 89081 | Germany |
| Hong Kong | 852 | Hong Kong |
| Hong Kong | Hong Kong |
| Bangalore | 560029 | India |
| Chennai | 600035 | India |
| Jaipur | 302004 | India |
| Kochi | 682304 | India |
| Kolkata | 700053 | India |
| Ludhiana | 141 001 | India |
| Mumbai | 400012 | India |
| New Delhi | 110076 | India |
| Pune | 411 001 | India |
| Vellore | 632004 | India |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Udine | Friuli Venezia Giulia | 33100 | Italy |
| Riga | LV-1002 | Latvia |
| Kaunas | 50009 | Lithuania |
| Vilnius | 08660 | Lithuania |
| Vilnius | 08661 | Lithuania |
| George Town | 11200 | Malaysia |
| Kuala Lumpur | 59100 | Malaysia |
| Monterrey | 64020 | Mexico |
| Arequipa | 04001 | Peru |
| Chiclayo | CIX | Peru |
| San Isidro | L27 Lima | Peru |
| Bucharest | Romania |
| Cluj-Napoca | 400015 | Romania |
| Craiova (Dolj County) | 200535 | Romania |
| Irkutsk | 664035 | Russia |
| Kazan' | 420111 | Russia |
| Krasnodar | 350040 | Russia |
| Moscow | 115478 | Russia |
| Saint Petersburg | 195067 | Russia |
| Saint Petersburg | 198255 | Russia |
| Singapore | 169610 | Singapore |
| Ljubljana | 1000 | Slovenia |
| Kiev | 36022 | Ukraine |
| London | EC1A 7BE | United Kingdom |
| London | N18 1QX | United Kingdom |
| London | SE1 9RT | United Kingdom |
| London | SW3 6JJ | United Kingdom |
| Sutton | SM2 5PT | United Kingdom |
| FG001 | Erlotinib | Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death. |
| Switch to Open-Label Erlotinib |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death. |
| BG001 | Erlotinib | Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death. |
| 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, Customized | Number | participants |
| ||||||||||||||||||
| 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 | Progression-Free Survival | Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method. | The Full-Analysis Set (FAS) was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive. | Posted | Median | 95% Confidence Interval | weeks | From the time of randomization until progression of disease or death (up to 30 months) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Best Overall Response Rate | Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions. | The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive. | Posted | Number | 95% Confidence Interval | percentage of participants | From the time of randomization until progression of disease or death (up to 30 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Disease Control Rate (DCR) | Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. | The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death. | The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive. | Posted | Median | 95% Confidence Interval | months | From the time of randomization until or death (up to 30 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. | Safety population included all participants who received at least 1 dose of study medication and had a safety follow-up, whether withdrawn prematurely or not, were included in the safety population. | Posted | Number | participants | Up to 28 days after discontinuation of study drug (up to 30 months) |
|
Adverse events were assessed from baseline up to 28 days after discontinuation of study drug (up to 30 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 | Placebo | Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death. | 11 | 103 | 70 | 103 | ||
| EG001 | Erlotinib | Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death. | 21 | 104 | 81 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PYREXIA | General disorders | MedDRA (13.1) | Systematic Assessment |
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| DEVICE OCCLUSION | General disorders | MedDRA (13.1) | Systematic Assessment |
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| DRUG INTOLERANCE | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| BILE DUCT OBSTRUCTION | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
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| BILIARY DILATATION | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
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| CHOLANGITIS | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
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| CHOLANGITIS ACUTE | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
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| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
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| JAUNDICE CHOLESTATIC | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
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| HYDROPNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
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| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| HAEMATEMESIS | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| BILIARY SEPSIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
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| MORGANELLA INFECTION | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
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| SEPTIC SHOCK | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
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| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
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| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
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| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
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| ANASTOMOTIC ULCER | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
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| CONCUSSION | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
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| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
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| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
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| RENAL FAILURE | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
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| VENOUS THROMBOSIS | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| ASCITES | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
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| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (13.1) | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA (13.1) | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA (13.1) | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MedDRA (13.1) | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA (13.1) | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA (13.1) | 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-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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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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