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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024133-23 |
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This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tyrosine Kinase Inhibitor (TKI) Naive | Experimental | Vemurafenib in participants naive to any prior systemic TKI therapy. |
|
| TKI Experienced | Experimental | Vemurafenib in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vemurafenib | Drug | Vemurafenib 960 mg orally twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rate in TKI-Naive Participants | Best overall response rate was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate: the percentage of participants with best objective response of complete response (CR) or partial response (PR) (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 millimeters (mm). PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rate in TKI-Experienced Participants | Best overall response rate was assessed by the investigators according to RECIST v1.1. Best overall response rate: the percentage of participants with best objective response of CR or PR (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. |
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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 |
|---|---|---|---|---|---|---|
| Torrance | California | 90502 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27460442 | Derived | Brose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. doi: 10.1016/S1470-2045(16)30166-8. Epub 2016 Jul 23. |
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Written informed consent for participation in the study was obtained before performing any study-specific screening tests or evaluations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tyrosine Kinase Inhibitor (TKI) Naive | Vemurafenib 960 milligrams (mg) orally twice daily in participants naive to any prior systemic TKI therapy. |
| FG001 | TKI Experienced | Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to approximately 4 years |
| Clinical Benefit Rate | Clinical benefit rate: the percentage of participants with confirmed CR, PR, or stable disease (SD; maintained for at least 6 months) as assessed by investigators according to RECIST v1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to the baseline sum diameters. | Up to approximately 4 years |
| Duration of Response | Duration of response (for participants with confirmed best response CR or PR): the interval between earliest qualifying response and date of progression of disease (PD) or death for any cause, whichever occurred first; participants with no documented progression after CR or PR were censored at the date of last known CR or PR, respectively. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study. | From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years) |
| Progression-Free Survival | Progression-free survival: the interval between the day of first treatment and the first documentation of PD or death; participants who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression-free; participants without post baseline tumor assessments were censored at the time of enrollment. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study. | From the day of first treatment until the first documented PD or death (up to approximately 4 years) |
| Overall Survival | Overall survival: the interval between the date of first treatment to the date of death, regardless of the cause of death; participants who were alive at the time of the analysis were censored at the date of the last known alive; participants with no post baseline information were censored at the time of enrollment. | From the date of first treatment to the date of death for any cause (up to approximately 4 years) |
| Percentage of Participants With Adverse Events | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years) |
| Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC) | AUC is a measure of the drug or biologic concentration in the body following administration. | Up to approximately 4 years |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Chicago | Illinois | 60637 | United States |
| Baltimore | Maryland | 21231 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02215 | United States |
| New York | New York | 10017 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Houston | Texas | 77030 | United States |
| Lyon | 69008 | France |
| Paris | 75651 | France |
| Villejuif | 94805 | France |
| Milan | Lombardy | 20133 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Groningen | 9700 RB | Netherlands |
| Leiden | 2300 RC | Netherlands |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat population, defined as all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | TKI Naive | Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy. |
| BG001 | TKI Experienced | Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR. |
| 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 | 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 | Best Overall Response Rate in TKI-Naive Participants | Best overall response rate was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate: the percentage of participants with best objective response of complete response (CR) or partial response (PR) (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 millimeters (mm). PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. | Efficacy population (TKI Naive group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 4 years |
|
|
| |||||||||||||||||||||||||
| Secondary | Best Overall Response Rate in TKI-Experienced Participants | Best overall response rate was assessed by the investigators according to RECIST v1.1. Best overall response rate: the percentage of participants with best objective response of CR or PR (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. | Efficacy population (TKI Experienced group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 4 years |
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate | Clinical benefit rate: the percentage of participants with confirmed CR, PR, or stable disease (SD; maintained for at least 6 months) as assessed by investigators according to RECIST v1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to the baseline sum diameters. | Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 4 years |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response (for participants with confirmed best response CR or PR): the interval between earliest qualifying response and date of progression of disease (PD) or death for any cause, whichever occurred first; participants with no documented progression after CR or PR were censored at the date of last known CR or PR, respectively. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study. | Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | Posted | Median | 95% Confidence Interval | months | From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years) |
| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | Progression-free survival: the interval between the day of first treatment and the first documentation of PD or death; participants who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression-free; participants without post baseline tumor assessments were censored at the time of enrollment. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study. | Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | Posted | Median | 95% Confidence Interval | months | From the day of first treatment until the first documented PD or death (up to approximately 4 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival: the interval between the date of first treatment to the date of death, regardless of the cause of death; participants who were alive at the time of the analysis were censored at the date of the last known alive; participants with no post baseline information were censored at the time of enrollment. | Intent-to-Treat population, defined as all enrolled participants. | Posted | Median | 95% Confidence Interval | months | From the date of first treatment to the date of death for any cause (up to approximately 4 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Safety population, defined as enrolled participants who received at least one dose of study treatment. | Posted | Number | percentage of participants | Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC) | AUC is a measure of the drug or biologic concentration in the body following administration. | Data were not collected for this outcome. | Posted | Up to approximately 4 years |
|
|
Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years)
Safety population, defined as enrolled participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TKI Naive | Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy. | 16 | 26 | 26 | 26 | ||
| EG001 | TKI Experienced | Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR. | 18 | 25 | 24 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Large intestinal perforation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oral lichen planus | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Larygeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Viral labyrinthitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin lesions | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Scleral discolouration | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Leukoplakia oral | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Induration | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Dysplastic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vocal cord thickening | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Milia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nail growth abnormal | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | 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 |
| 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 |
|
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| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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