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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003144-80 | EudraCT Number |
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This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vemurafenib 480mg BID | Experimental | Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
|
| Vemurafenib 720mg BID | Experimental | Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
|
| Vemurafenib 960mg BID | Experimental | Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vemurafenib | Drug | Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Intensity of Vemurafenib | Dose Intensity was defined as (total actual doses taken/total planned doses) *100, where total planned doses = prescribed doses * planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose. | Baseline up to a maximum of 7 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. Reported are the Percentage of Participants with AEs and Serious Adverse Events (SAEs). |
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Inclusion Criteria:
Exclusion Criteria:
Participants meeting any of the following exclusion criterion of the antecedent study at the time the participant is considered for the extension (rollover) study:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Rogers | Arkansas | 72758 | United States | ||
| UCLA Department of Medicine |
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215 participants were enrolled into this OLE study and were included in the Safety population.
The study was conducted at 82 centers in 24 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vemurafenib 480mg BID | Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2018 |
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|
| Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years). |
| Los Angeles |
| California |
| 90024 |
| United States |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| University of Chicago Medical Center; Medicine, Section of Pulmonary | Chicago | Illinois | 60637 | United States |
| Siouxland Regional Cancer Center d/b/a June E. Nylen Cancer Center | Sioux City | Iowa | 51108 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| New York University Medical Center PRIME | New York | New York | 10016 | United States |
| Evelyn H. Lauder Center | New York | New York | 10065 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Mary Crowley Medical Research Center; Oncology | Dallas | Texas | 75246 | United States |
| M D Anderson Physician Network | Webster | Texas | 77598 | United States |
| University of Washington Seattle Cancer Care Alliance | Seattle | Washington | 98195 | United States |
| N.N. Alexandrov National Cancer Centre of Belarus | Minsk District | 223040 | Belarus |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| University Clinical Center of the Republic of Srpska | Banja Luka | 78000 | Bosnia and Herzegovina |
| University Clinic Centre Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | Brazil |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | H3T 1E2 | Canada |
| Clinical Hospital Center Sestre Milosrdnice | Zagreb | 10000 | Croatia |
| Clinical Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Bank of Cyprus Oncology Center | Nicosia | 2006 | Cyprus |
| Medical Research Institute | Alexandria | 21131 | Egypt |
| National Cancer Institute | Cairo | 11796 | Egypt |
| Mansoura University Hospital | Dakahlia | 324 | Egypt |
| Gharbia Cancer Society | Tanta | Egypt |
| Centre Léon Bérard | Lyon | 69373 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke | Mainz | 55131 | Germany |
| Universitätsklinikum Wurzburg | Würzburg | 97080 | Germany |
| University General Hospital of Heraklion | Crete | 711 10 | Greece |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Orszagos Onkologiai Intezet | Budapest | 1122 | Hungary |
| Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely | Budapest | H-1077 | Hungary |
| Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika | Debrecen | 4012 | Hungary |
| Pecsi Tudomanyegyetem | Pécs | 7624 | Hungary |
| Rambam Health Care Campus | Haifa | 3109600 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit | Ramat Gan | 5266202 | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda) | Milan | Lombardy | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Christchurch Clinical Studies Trust | Christchurch | 8011 | New Zealand |
| IPO de Lisboa; Servico de Oncologia Medica | Lisbon | 1099-023 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| Medisprof SRL | Cluj-Napoca | 400058 | Romania |
| FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement | Moskva | Moscow Oblast | 115478 | Russia |
| Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic | Kazan' | 420029 | Russia |
| SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2 | Krasnodar | 350040 | Russia |
| Moscow city oncology hospital #62 of Moscow Healthcare Department | Moscow | 143423 | Russia |
| St. Petersburg SHI "City Clinical Oncology Dispensary" | Saint Petersburg | 197022 | Russia |
| SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan | Ufa | 450054 | Russia |
| Institute for Oncology and Radiology of Serbia; Medical Oncology | Belgrade | 11000 | Serbia |
| Clinical Center Bezanijska Kosa | Belgrade | 11070 | Serbia |
| Cape Town Oncology Trials | Cape Town | 7570 | South Africa |
| Wits Donald Gordon Clinical Trial Centre; Medical Oncology | Parktown, Johannesburg | 2193 | South Africa |
| Cancercare Langenhoven Drive Oncology Centre | Port Elizabeth | 6045 | South Africa |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Samsung Medical Center | Seoul | (0)6351 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07010 | Spain |
| Hospital Universitario Marques de Valdecilla; Servicio de Oncologia | Santander | Cantabria | 39008 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | LA Coruña | 15006 | Spain |
| Hospital Regional Universitario de Malaga; Oncologia | Málaga | Malaga | 29010 | Spain |
| Hospital General Universitario Santa Lucia | Cartagena (Murcia) | Murcia | 30202 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario La Paz | Madrid | 280146 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clínico San Carlos; Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| START Madrid. Centro Integral Oncologico Clara Campal; CIOCC | Madrid | 28050 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Instituto Valenciano Oncologia; Oncologia Medica | Valencia | 46009 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Royal Marsden Hospital | Surrey | SM2 5PT | United Kingdom |
| FG001 | Vemurafenib 720mg BID | Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
| FG002 | Vemurafenib 960mg BID | Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vemurafenib 480mg BID | Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
| BG001 | Vemurafenib 720mg BID | Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
| BG002 | Vemurafenib 960mg BID | Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
| BG003 | 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Ethnicity | Number | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race | Number | 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 | Dose Intensity of Vemurafenib | Dose Intensity was defined as (total actual doses taken/total planned doses) *100, where total planned doses = prescribed doses * planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose. | The Safety-evaluable population was defined as all participants who received at least one dose of study medication. Please note that for this Outcome Measure, one participant who received 960 mg BID of Vemurafenib had no treatment end date indicated and was excluded from the calculation of study treatment exposure summaries. | Posted | Mean | Standard Deviation | Percentage of Planned Dose | Baseline up to a maximum of 7 years. |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. Reported are the Percentage of Participants with AEs and Serious Adverse Events (SAEs). | The Safety-evaluable population was defined as all participants who received at least one dose of study medication. | Posted | Number | Percentage of Participants | Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years). |
|
Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
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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 | Vemurafenib 480mg BID | Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. | 4 | 29 | 14 | 29 | 21 | 29 |
| EG001 | Vemurafenib 720mg BID | Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. | 6 | 40 | 15 | 40 | 29 | 40 |
| EG002 | Vemurafenib 960mg BID | Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. | 38 | 146 | 29 | 146 | 119 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| CATARACT NUCLEAR | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| PAROPHTHALMIA | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| DIVERTICULAR PERFORATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| HAEMOPERITONEUM | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| OESOPHAGEAL STENOSIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 23.0 | Systematic Assessment |
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| DEATH | General disorders | MedDRA 23.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 23.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 23.0 | Systematic Assessment |
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| JAUNDICE | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| ERYSIPELAS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| MENINGITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| SINUSITIS BACTERIAL | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| TRACHEAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
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| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
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| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
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| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
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| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 23.0 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| MYOPATHY TOXIC | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BRAIN NEOPLASM BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| CEREBRAL HAEMANGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| METASTASES TO LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| METASTATIC MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| EPILEPSY | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| FACIAL PARALYSIS | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| HYDROCEPHALUS | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ANXIETY DISORDER | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| BIPOLAR DISORDER | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| RENAL COLIC | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| TRACHEAL RESECTION | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| GLAUCOMA | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| UVEITIS | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CHORIORETINITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| SUNBURN | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| MELANOCYTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DERMAL CYST | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERKERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PANNICULITIS | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 23.0 | 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-La Roche | 800 821-8590 | genentech@druginfo.com |
| Oct 26, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077484 | Vemurafenib |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Not Stated |
|
| Unknown |
|
| Black or African American |
|
| White |
|
| Other |
|
| Unknown |
|
Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
| OG002 | Vemurafenib 960mg BID | Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first. |
|
|