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This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib [RG7204; PLEXXIKON: PLX4032] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is <100 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vemurafenib | Drug | 960 mg b.i.d. continuous oral dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion. | From first treatment through September 27, 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion. |
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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 |
|---|---|---|---|---|---|---|
| UCLA - School of Medicine; Division of Hematology/Oncology | Los Angeles | California | 90095-6984 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32746839 | Derived | Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dreno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib +/- cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x. | |
| 24983357 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vemurafenib 960 mg | Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From first treatment through September 27, 2010 |
| Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment. | From first treatment through September 27, 2010 |
| Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first. | From first treatment through September 27, 2010 |
| Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date. | From first treatment through September 27, 2010 |
| Overall Survival | Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date. | From first treatment through September 27, 2010 |
| Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline | Three parameters were measured. (1) Improvement in the Physician's Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value < 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported. | From first treatment through September 27, 2010 |
| Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1 | Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). | Pre-dose to 8 hours post-dose on Day 15 of Cycle 1 |
| Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1 | Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule. | Pre-dose to 8 hours post-dose on Day 15 of Cycle 1 |
| Vemurafenib Plasma Levels at Various Treatment Cycles | Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration. | Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1 |
| Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP) | Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)^β (β=mean [calculated separately for males and females] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values. | Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1 |
| Percentage of Patients With Adverse Event | The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death). | From first treatment through September 27, 2010 |
| University of Colorado |
| Denver |
| Colorado |
| 80262 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Massachusetts General Hospital;Hematology/ Oncology | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Inst. ; Dept. of Medical Oncology | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| New York University Medical Center | New York | New York | 10036 | United States |
| Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology | Philadelphia | Pennsylvania | 19104-4283 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt-Ingram Cancer Ctr | Nashville | Tennessee | 37232 | United States |
| Texas Oncology-Baylor Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Calvary Mater Newcastle; Melanoma Clinic | Newcastle | New South Wales | 2298 | Australia |
| Westmead Hospital; Medical Oncology and Pallative Care | Westmead | New South Wales | 2145 | Australia |
| Peter Maccallum Cancer Institute; Medical Oncology | Melbourne | Victoria | 3000 | Australia |
| Derived |
| Frederick DT, Salas Fragomeni RA, Schalck A, Ferreiro-Neira I, Hoff T, Cooper ZA, Haq R, Panka DJ, Kwong LN, Davies MA, Cusack JC, Flaherty KT, Fisher DE, Mier JW, Wargo JA, Sullivan RJ. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. PLoS One. 2014 Jul 1;9(7):e101286. doi: 10.1371/journal.pone.0101286. eCollection 2014. |
| 23457002 | Derived | Lacouture ME, Duvic M, Hauschild A, Prieto VG, Robert C, Schadendorf D, Kim CC, McCormack CJ, Myskowski PL, Spleiss O, Trunzer K, Su F, Nelson B, Nolop KB, Grippo JF, Lee RJ, Klimek MJ, Troy JL, Joe AK. Analysis of dermatologic events in vemurafenib-treated patients with melanoma. Oncologist. 2013;18(3):314-22. doi: 10.1634/theoncologist.2012-0333. Epub 2013 Mar 1. |
| 22356324 | Derived | Sosman JA, Kim KB, Schuchter L, Gonzalez R, Pavlick AC, Weber JS, McArthur GA, Hutson TE, Moschos SJ, Flaherty KT, Hersey P, Kefford R, Lawrence D, Puzanov I, Lewis KD, Amaravadi RK, Chmielowski B, Lawrence HJ, Shyr Y, Ye F, Li J, Nolop KB, Lee RJ, Joe AK, Ribas A. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. N Engl J Med. 2012 Feb 23;366(8):707-14. doi: 10.1056/NEJMoa1112302. |
| 22256804 | Derived | Su F, Viros A, Milagre C, Trunzer K, Bollag G, Spleiss O, Reis-Filho JS, Kong X, Koya RC, Flaherty KT, Chapman PB, Kim MJ, Hayward R, Martin M, Yang H, Wang Q, Hilton H, Hang JS, Noe J, Lambros M, Geyer F, Dhomen N, Niculescu-Duvaz I, Zambon A, Niculescu-Duvaz D, Preece N, Robert L, Otte NJ, Mok S, Kee D, Ma Y, Zhang C, Habets G, Burton EA, Wong B, Nguyen H, Kockx M, Andries L, Lestini B, Nolop KB, Lee RJ, Joe AK, Troy JL, Gonzalez R, Hutson TE, Puzanov I, Chmielowski B, Springer CJ, McArthur GA, Sosman JA, Lo RS, Ribas A, Marais R. RAS mutations in cutaneous squamous-cell carcinomas in patients treated with BRAF inhibitors. N Engl J Med. 2012 Jan 19;366(3):207-15. doi: 10.1056/NEJMoa1105358. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vemurafenib 960 mg | Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator. |
| 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 (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion. | Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first treatment through September 27, 2010 |
|
|
| |||||||||||||||||||||||||
| Secondary | Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion. | Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first treatment through September 27, 2010 |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment. | Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib. | Posted | Median | 95% Confidence Interval | Months | From first treatment through September 27, 2010 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first. | Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib. | Posted | Median | Inter-Quartile Range | Months | From first treatment through September 27, 2010 |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date. | Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib. | Posted | Median | 95% Confidence Interval | Months | From first treatment through September 27, 2010 |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date. | Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib. | Posted | Median | 95% Confidence Interval | Months | From first treatment through September 27, 2010 |
|
| ||||||||||||||||||||||||||
| Secondary | Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline | Three parameters were measured. (1) Improvement in the Physician's Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value < 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported. | Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first treatment through September 27, 2010 |
|
| ||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1 | Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). | Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose to 8 hours post-dose on Day 15 of Cycle 1 |
|
| ||||||||||||||||||||||||||
| Secondary | Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1 | Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule. | Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15. | Posted | Mean | Standard Deviation | μg⋅h/mL | Pre-dose to 8 hours post-dose on Day 15 of Cycle 1 |
|
| ||||||||||||||||||||||||||
| Secondary | Vemurafenib Plasma Levels at Various Treatment Cycles | Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration. | Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP) | Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)^β (β=mean [calculated separately for males and females] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values. | Electrocardiogram (ECG) evaluable population: All treated patients who had a baseline ECG and at least one ECG during treatment. | Posted | Mean | 95% Confidence Interval | ms | Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Adverse Event | The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death). | Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib. | Posted | Number | Percentage of participants | From first treatment through September 27, 2010 |
|
|
Screening through 6 months after the last patient enrolled
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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 960 mg | Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator. | 67 | 132 | 131 | 132 |
| 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 13.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| KERATOACANTHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| BREAST CELLULITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| PSEUDOMONAS INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| SALMONELLOSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| FACIAL PALSY | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| BILIRUBIN CONJUGATED INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HEPATIC CYST | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RASH VESICULAR | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RETINAL VEIN OCCLUSION | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| LEFT LUNG GROUND GLASS OPACITIES-PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| SKIN PAPILLOMA | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| HYPERKERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| KERATOSIS PILARIS | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| PALMAR-PLANTAR | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ERYTHRODYSAESTHESIA SYNDROME ACNE | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 13.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 13.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 13.0 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| SUNBURN | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
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| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
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| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
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| SEBORRHOEIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| FOLLICULITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| MELANOCYTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | 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 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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
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