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Trial record 18 of 30 for:    ( Map: Albania )

A Study of Vemurafenib in Participants With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01307397
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Melanoma
Intervention Drug: Vemurafenib
Enrollment 3219
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vemurafenib
Hide Arm/Group Description Participants received continuous oral doses of vemurafenib 960 milligrams (mg) (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Period Title: Overall Study
Started 3219
Completed 3219 [1]
Not Completed 0
[1]
A participant completed study in case of progressive disease, adverse events or consent withdrawn
Arm/Group Title Vemurafenib
Hide Arm/Group Description Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Baseline Participants 3219
Hide Baseline Analysis Population Description
The safety population included all participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3219 participants
54.5  (14.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3219 participants
Female
1397
  43.4%
Male
1822
  56.6%
1.Primary Outcome
Title Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0
Hide Description The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the NCI-CTCAE version 4.0, where Grade 1 indicates "Mild" severity and Grade 5 indicates "Death". The CTCAE defines Grades 3 and 4 as follows: Grade 3 means "Severe"; Inability to work or perform normal daily activity; treatment or medical intervention is indicated in order to improve the overall well-being or symptoms; delaying the onset of treatment is not putting the survival of the participant at direct risk. Grade 4 means "Life-threatening, Disabling"; based on extreme limitation in activity; significant medical intervention/therapy required; and hospitalization probable.
Time Frame Baseline up to 28 days post end of treatment (maximum up to 46 months)
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Safety population. Number of participants analyzed = participants with measurable disease at baseline
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Measure Type: Number
Unit of Measure: Percentage of participants
52.8
2.Primary Outcome
Title Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation
Hide Description An AE was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Pre existing conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Percentage of participants with dose interruption or discontinuation due to AE was presented.
Time Frame Baseline up to 28 days post end of treatment (maximum up to 46 months)
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Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Measure Type: Number
Unit of Measure: Percentage of participants
AE Leading to Drug Discontinuation 7.0
AE Leading to Study Drug Interruption 34.0
3.Primary Outcome
Title Percentage of Participants With AEs of Special Interest
Hide Description AEs of special interest included cutaneous squamous cell carcinoma (SCC), rash, photosensitivity, liver injury, arthralgia, fatigue, gastrointestinal (GI) polyps, pancreatitis, potentiation of radiation toxicity, prolongation of cardiac repolarization or arrhythmia, non-cutaneous SCC and other primary malignancies (other than cutaneous SCC or new primary melanoma).
Time Frame Baseline up to 28 days post end of treatment (maximum up to 46 months)
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Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Measure Type: Number
Unit of Measure: Percentage of participants
Arthralgia 42.3
Rash 47.9
Photosensitivity 28.4
Fatigue 36.8
Cutaneous SCC 14.6
Non Cutaneous SCC 0.1
New Primary Melanoma 1.7
GI Polyps 0.03
Pancreatitis 0.2
Potentiation of radiation toxicity 1.4
Prolongation of Cardiac Repolarization/ Arrhythmia 17.0
Other primary malignancy 3.2
Liver Injury 14.1
4.Primary Outcome
Title Mean Cumulative Dose of Vemurafenib
Hide Description [Not Specified]
Time Frame Baseline up to end of treatment or death (maximum up to 46 months)
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Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Mean (Standard Deviation)
Unit of Measure: Grams
501.283  (510.9121)
5.Primary Outcome
Title Duration of Vemurafenib Treatment
Hide Description

Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.

Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation.

Time Frame Baseline up to end of treatment or death (maximum upto 46 months)
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Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Mean (Standard Deviation)
Unit of Measure: Months
Exposure excluding interruptions 9.383  (9.6755)
Exposure including interruptions 9.724  (9.9072)
6.Primary Outcome
Title Mean Total Vemurafenib Dose Per Day
Hide Description

Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.

Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation. Average total dose per day: total actual dose taken divided by total actual days on treatment.

Time Frame Baseline up to end of treatment or death (maximum up to 46 months)
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Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Mean (Standard Deviation)
Unit of Measure: Grams
Average Total Dose Per Day Excluding Interruptions 1.802  (0.2314)
Average Total Dose Per Day Including Interruptions 1.732  (0.2874)
7.Primary Outcome
Title Dose Intensity of Vemurafenib
Hide Description 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.
Time Frame Baseline up to end of treatment or death (maximum upto 46 months)
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Safety Population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Mean (Standard Deviation)
Unit of Measure: Percentage of planned dose
90.21  (14.966)
8.Secondary Outcome
Title Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status
Hide Description ECOG Performance Status was measured on-therapy assessed participant's performance status on 5 point scale: 0 = fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Percentage of participants who had at least one point improvement from baseline at any assessment visit as well as at last study visit was reported.
Time Frame Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)
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Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Measure Type: Number
Unit of Measure: Percentage of Participants
At Least 1 Point Improvement at Any Visit 24.7
At Least 1 Point Improvement at Last Visit 9.9
9.Secondary Outcome
Title Percentage of Participants Who Received Any Concomitant Medications
Hide Description Concomitant medications were all medications taken during the study, including those started before but ongoing at first dose. No medications for Melanoma were included. Percentage of participants who received at least one concomitant medication was reported.
Time Frame Baseline up to 46 months
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Hide Analysis Population Description
Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Measure Type: Number
Unit of Measure: Percentage of Participants
93.8
10.Secondary Outcome
Title Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Hide Description

BOR was assessed by the investigator according to RECIST v1.1. BOR was defined as having confirmed CR or PR. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions.

Confirmed responses were those that persisted on repeat imaging greater than or equal to (>=) 4 weeks after initial response.

Time Frame Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = participants with measurable disease at baseline.
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 2982
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
33.4
(31.7 to 35.1)
11.Secondary Outcome
Title Duration of Response
Hide Description The duration of response was defined as the time between the date of first confirmed CR or PR and date of first progression of disease (PD), or death, from any cause. Responses were assessed as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response. PD: at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.
Time Frame From 1st documentation of confirmed CR or PR to PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until end of the study [up to 46 months])
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Safety population. Number of participants analysed=participants who achieved CR or PR.
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 996
Median (95% Confidence Interval)
Unit of Measure: Months
7.4
(7.1 to 8.3)
12.Secondary Outcome
Title Time to Response
Hide Description Time to response was defined as the time between the date of first treatment and date of first confirmed CR or PR (assessed as per RECIST v1.1). CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response.
Time Frame Baseline until first documentation of confirmed CR or PR, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = participants with measurable disease at baseline.
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 2982
Median (Full Range)
Unit of Measure: Months
1.84
(0.8 to 26.7)
13.Secondary Outcome
Title Percentage of Participants With PD Assessed According to RECIST v1.1 or Death
Hide Description PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.
Time Frame Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
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Hide Analysis Population Description
Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Measure Type: Number
Unit of Measure: Percentage of Participants
87.3
14.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time between the date of the first treatment and the date of first progression or death from any cause. PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.
Time Frame Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Median (95% Confidence Interval)
Unit of Measure: Months
5.6
(5.5 to 5.8)
15.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description [Not Specified]
Time Frame Baseline until death (maximum up to 46 months)
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Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Measure Type: Number
Unit of Measure: Percentage of participants
63.8
16.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.
Time Frame Baseline until death (maximum up to 46 months)
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Safety population
Arm/Group Title Vemurafenib
Hide Arm/Group Description:
Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
Overall Number of Participants Analyzed 3219
Median (95% Confidence Interval)
Unit of Measure: Months
12.1
(11.5 to 12.7)
Time Frame Baseline up to 28 days post end of treatment (maximum up to 46 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vemurafenib
Hide Arm/Group Description Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.
All-Cause Mortality
Vemurafenib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vemurafenib
Affected / at Risk (%)
Total   1114/3219 (34.61%) 
Blood and lymphatic system disorders   
Anaemia * 1  22/3219 (0.68%) 
Disseminated intravascular coagulation * 1  2/3219 (0.06%) 
Eosinophilia * 1  1/3219 (0.03%) 
Neutropenia * 1  3/3219 (0.09%) 
Thrombocytopenia * 1  1/3219 (0.03%) 
Agranulocytosis * 1  1/3219 (0.03%) 
Febrile neutropenia * 1  1/3219 (0.03%) 
Lymph node pain * 1  1/3219 (0.03%) 
Microcytic anaemia * 1  2/3219 (0.06%) 
Cardiac disorders   
Acute myocardial infarction * 1  10/3219 (0.31%) 
Angina pectoris * 1  5/3219 (0.16%) 
Arrhythmia * 1  1/3219 (0.03%) 
Atrial fibrillation * 1  15/3219 (0.47%) 
Atrial flutter * 1  4/3219 (0.12%) 
Cardiac failure * 1  6/3219 (0.19%) 
Coronary artery disease * 1  3/3219 (0.09%) 
Left ventricular dysfunction * 1  2/3219 (0.06%) 
Myocardial infarction * 1  7/3219 (0.22%) 
Pericardial effusion * 1  7/3219 (0.22%) 
Pericardial haemorrhage * 1  1/3219 (0.03%) 
Pericarditis * 1  7/3219 (0.22%) 
Tachycardia * 1  1/3219 (0.03%) 
Torsade de pointes * 1  1/3219 (0.03%) 
Acute coronary syndrome * 1  1/3219 (0.03%) 
Angina unstable * 1  2/3219 (0.06%) 
Atrioventricular block * 1  1/3219 (0.03%) 
Cardiac arrest * 1  2/3219 (0.06%) 
Cardiac failure acute * 1  2/3219 (0.06%) 
Cardiac failure congestive * 1  3/3219 (0.09%) 
Cardiogenic shock * 1  1/3219 (0.03%) 
Cardiomyopathy * 1  1/3219 (0.03%) 
Coronary artery stenosis * 1  1/3219 (0.03%) 
Sinus node dysfunction * 1  1/3219 (0.03%) 
Supraventricular tachycardia * 1  3/3219 (0.09%) 
Ear and labyrinth disorders   
Deafness * 1  1/3219 (0.03%) 
Vertigo * 1  1/3219 (0.03%) 
Hearnig impaired * 1  1/3219 (0.03%) 
Endocrine disorders   
Hyperadrenalism * 1  1/3219 (0.03%) 
Eye disorders   
Neovascular age-related macular degeneration * 1  1/3219 (0.03%) 
Diplopia * 1  1/3219 (0.03%) 
Iridocyclitis * 1  3/3219 (0.09%) 
Uveitis * 1  6/3219 (0.19%) 
Vitreous haemorrhage * 1  1/3219 (0.03%) 
Cataract * 1  2/3219 (0.06%) 
Glaucoma * 1  2/3219 (0.06%) 
Macular oedema * 1  2/3219 (0.06%) 
Papilloedema * 1  2/3219 (0.06%) 
Retinal artery occlusion * 1  1/3219 (0.03%) 
Retinal detachment * 1  1/3219 (0.03%) 
Retinopathy * 1  1/3219 (0.03%) 
Iritis * 1  2/3219 (0.06%) 
Gastrointestinal disorders   
Abdominal distension * 1  1/3219 (0.03%) 
Abdominal pain * 1  4/3219 (0.12%) 
Abdominal pain lower * 1  1/3219 (0.03%) 
Abdominal pain upper * 1  1/3219 (0.03%) 
Ascites * 1  1/3219 (0.03%) 
Constipation * 1  6/3219 (0.19%) 
Diarrhoea * 1  16/3219 (0.50%) 
Diverticular perforation * 1  1/3219 (0.03%) 
Duodenal ulcer * 1  2/3219 (0.06%) 
Gastrointestinal haemorrhage * 1  3/3219 (0.09%) 
Gastrooesophageal reflux disease * 1  2/3219 (0.06%) 
Heamatemesis * 1  1/3219 (0.03%) 
Ileus * 1  3/3219 (0.09%) 
Inguinal hernia * 1  3/3219 (0.09%) 
Intestinal obstruction * 1  2/3219 (0.06%) 
Intestinal perforation * 1  3/3219 (0.09%) 
Jejunal perforation * 1  1/3219 (0.03%) 
Nausea * 1  13/3219 (0.40%) 
Oesophagitis * 1  1/3219 (0.03%) 
Pancreatitis * 1  4/3219 (0.12%) 
Pancreatitis acute * 1  3/3219 (0.09%) 
Small intestinal obstruction * 1  2/3219 (0.06%) 
Vomiting * 1  17/3219 (0.53%) 
Anal fistula * 1  2/3219 (0.06%) 
Anal skin tags * 1  1/3219 (0.03%) 
Colitis * 1  2/3219 (0.06%) 
Dyspepsia * 1  1/3219 (0.03%) 
Dysphagia * 1  1/3219 (0.03%) 
Enteroocolitis * 1  1/3219 (0.03%) 
Faeces pale * 1  1/3219 (0.03%) 
Food poisoning * 1  1/3219 (0.03%) 
Gastritis haemorrhagic * 1  1/3219 (0.03%) 
Gastrointestinal necrosis * 1  1/3219 (0.03%) 
Gastrointestinal toxicity * 1  1/3219 (0.03%) 
Haemorrhoidal haemorrhage * 1  1/3219 (0.03%) 
Intestinal ischaemia * 1  1/3219 (0.03%) 
Intussusception * 1  1/3219 (0.03%) 
Large intestine perforation * 1  1/3219 (0.03%) 
Leukoplakia oral * 1  1/3219 (0.03%) 
Lower gastrointestinal haemorrhage * 1  1/3219 (0.03%) 
Melaena * 1  1/3219 (0.03%) 
Mouth ulceration * 1  1/3219 (0.03%) 
Paraesthesia oral * 1  1/3219 (0.03%) 
Rectal haemorrhage * 1  1/3219 (0.03%) 
Retroperitoneal haematoma * 1  1/3219 (0.03%) 
General disorders   
Chest pain * 1  3/3219 (0.09%) 
Chills * 1  1/3219 (0.03%) 
Chronic fatigue syndrome * 1  1/3219 (0.03%) 
Death * 1  7/3219 (0.22%) 
Device dislocation * 1  1/3219 (0.03%) 
Drug interaction * 1  1/3219 (0.03%) 
Fatigue * 1  6/3219 (0.19%) 
General physical health deterioration * 1  9/3219 (0.28%) 
Malaise * 1  2/3219 (0.06%) 
Multi-organ disorder * 1  1/3219 (0.03%) 
Multi-organ failure * 1  2/3219 (0.06%) 
Oedema * 1  1/3219 (0.03%) 
Oedema peripheral * 1  1/3219 (0.03%) 
Visceral pain * 1  1/3219 (0.03%) 
Pyrexia * 1  32/3219 (0.99%) 
Sudden cardiac death * 1  1/3219 (0.03%) 
Asthenia * 1  2/3219 (0.06%) 
Generalised oedema * 1  1/3219 (0.03%) 
Impaired healing * 1  1/3219 (0.03%) 
Surgical failure * 1  1/3219 (0.03%) 
Euthanasia * 1  2/3219 (0.06%) 
Hepatobiliary disorders   
Cholecystitis acute * 1  4/3219 (0.12%) 
Cholelithiasis * 1  1/3219 (0.03%) 
Drug-induced liver injury * 1  4/3219 (0.12%) 
Hepatic function abnormal * 1  1/3219 (0.03%) 
Hepatitis * 1  1/3219 (0.03%) 
Hepatotoxicity * 1  3/3219 (0.09%) 
Cholangitis * 1  1/3219 (0.03%) 
Cholecystitis * 1  3/3219 (0.09%) 
Hepatic failure * 1  1/3219 (0.03%) 
Hepatitis toxic * 1  1/3219 (0.03%) 
Immune system disorders   
Drug hypersensitivity * 1  1/3219 (0.03%) 
Hypersensitivity * 1  2/3219 (0.06%) 
Food allergy * 1  1/3219 (0.03%) 
Infections and infestations   
Abscess limb * 1  1/3219 (0.03%) 
Anal abscess * 1  5/3219 (0.16%) 
Blastocystis infection * 1  1/3219 (0.03%) 
Bronchitis * 1  1/3219 (0.03%) 
Cellulitis * 1  5/3219 (0.16%) 
Clostridium difficile infection * 1  1/3219 (0.03%) 
Device related infection * 1  4/3219 (0.12%) 
Diverticulitis * 1  2/3219 (0.06%) 
Erysipelas * 1  9/3219 (0.28%) 
Escherichia bacteraemia * 1  1/3219 (0.03%) 
Escherichia sepsis * 1  2/3219 (0.06%) 
Gastroenteritis * 1  4/3219 (0.12%) 
Groin abscess * 1  5/3219 (0.16%) 
Herpes zoster * 1  3/3219 (0.09%) 
H1N1 influenza * 1  1/3219 (0.03%) 
Infection * 1  2/3219 (0.06%) 
Lower respiratory tract infection * 1  7/3219 (0.22%) 
Lung infection * 1  6/3219 (0.19%) 
Oesophageal candidiasis * 1  3/3219 (0.09%) 
Oral candidiasis * 1  1/3219 (0.03%) 
Otitis externa * 1  1/3219 (0.03%) 
Pilonidal cyst * 1  2/3219 (0.06%) 
Pharyngotonsillitis * 1  1/3219 (0.03%) 
Pneumocystis jiroveci pneumonia * 1  2/3219 (0.06%) 
Pneumonia * 1  31/3219 (0.96%) 
Postoperative wound infection * 1  2/3219 (0.06%) 
Rash pustular * 1  1/3219 (0.03%) 
Respiratory tract infection * 1  7/3219 (0.22%) 
Salmonella sepsis * 1  1/3219 (0.03%) 
Sepsis * 1  7/3219 (0.22%) 
Septic shock * 1  1/3219 (0.03%) 
Skin infection * 1  1/3219 (0.03%) 
Subcutaneous abscess * 1  1/3219 (0.03%) 
Upper respiratory tract infection * 1  4/3219 (0.12%) 
Urinary tract infection * 1  11/3219 (0.34%) 
Urosepsis * 1  1/3219 (0.03%) 
Viral infection * 1  3/3219 (0.09%) 
Vulvitis * 1  1/3219 (0.03%) 
Wound infection * 1  4/3219 (0.12%) 
Wound infection staphylococcal * 1  1/3219 (0.03%) 
Acinetobacter infection * 1  1/3219 (0.03%) 
Appendicitis * 1  1/3219 (0.03%) 
Appendicitis perforated * 1  1/3219 (0.03%) 
Arthritis bacterial * 1  1/3219 (0.03%) 
Brain Abscess * 1  1/3219 (0.03%) 
Atypical pneumonia * 1  1/3219 (0.03%) 
Cholecystitis infective * 1  1/3219 (0.03%) 
Colonic abscess * 1  2/3219 (0.06%) 
Cystitis * 1  1/3219 (0.03%) 
Gastroenteritis viral * 1  1/3219 (0.03%) 
Gastrointestinal infection * 1  2/3219 (0.06%) 
Hypopyon * 1  1/3219 (0.03%) 
Infected dermal cyst * 1  1/3219 (0.03%) 
Infectious pleural effusion * 1  1/3219 (0.03%) 
Localised infection * 1  2/3219 (0.06%) 
Lymph gland infection * 1  1/3219 (0.03%) 
Ophthalmic herpes zoster * 1  1/3219 (0.03%) 
Perineal abscess * 1  1/3219 (0.03%) 
Skin bacterial infection * 1  1/3219 (0.03%) 
Soft tissue infection * 1  1/3219 (0.03%) 
Subdiaphragmatic abscess * 1  1/3219 (0.03%) 
Tonsillitis * 1  1/3219 (0.03%) 
Tooth abscess * 1  1/3219 (0.03%) 
Tooth infection * 1  1/3219 (0.03%) 
Clostridium colitis * 1  1/3219 (0.03%) 
Injury, poisoning and procedural complications   
Alcohol Poisoning * 1  1/3219 (0.03%) 
Fall * 1  4/3219 (0.12%) 
Femoral neck fracture * 1  3/3219 (0.09%) 
Over dose * 1  2/3219 (0.06%) 
Hip fracture * 1  1/3219 (0.03%) 
Post procedural haemorrhage * 1  2/3219 (0.06%) 
Radiation injury * 1  2/3219 (0.06%) 
Respiratory fume inhalation disorder * 1  1/3219 (0.03%) 
Spinal fracture * 1  1/3219 (0.03%) 
Cystitis radiation * 1  1/3219 (0.03%) 
Facial bone fracture * 1  2/3219 (0.06%) 
Femur fracture * 1  4/3219 (0.12%) 
Fracture * 1  1/3219 (0.03%) 
Fracture displacement * 1  1/3219 (0.03%) 
Head injury * 1  1/3219 (0.03%) 
Humerus fracture * 1  1/3219 (0.03%) 
Lumbar vertebral fracture * 1  2/3219 (0.06%) 
Multiple injuries * 1  1/3219 (0.03%) 
Patella fracture * 1  1/3219 (0.03%) 
Radiation necrosis * 1  4/3219 (0.12%) 
Radius fracture * 1  1/3219 (0.03%) 
Road traffic accident * 1  1/3219 (0.03%) 
Spinal compression fracture * 1  1/3219 (0.03%) 
Splenic rupture * 1  1/3219 (0.03%) 
Subdural haematoma * 1  1/3219 (0.03%) 
Sunburn * 1  1/3219 (0.03%) 
Tendon injury * 1  1/3219 (0.03%) 
Tibia fracture * 1  1/3219 (0.03%) 
Toxicity to various agents * 1  2/3219 (0.06%) 
Investigations   
Aspartate aminotransferase increased * 1  1/3219 (0.03%) 
Blood creatinine increased * 1  7/3219 (0.22%) 
C-reactive protein increased * 1  1/3219 (0.03%) 
Gamma glutamyltransferase increased * 1  2/3219 (0.06%) 
Hepatic enzyme increased * 1  1/3219 (0.03%) 
Lipase increased * 1  1/3219 (0.03%) 
Liver function test abnormal * 1  3/3219 (0.09%) 
Blood glucose increased * 1  2/3219 (0.06%) 
Electrocardiogram QT prolonged * 1  3/3219 (0.09%) 
Metabolism and nutrition disorders   
Cachexia * 1  1/3219 (0.03%) 
Dehydration * 1  4/3219 (0.12%) 
Diabetes mellitus * 1  4/3219 (0.12%) 
Diabetic ketoacidosis * 1  2/3219 (0.06%) 
Hyperglycaemia * 1  2/3219 (0.06%) 
Hyperuricaemia * 1  2/3219 (0.06%) 
Hypokalaemia * 1  1/3219 (0.03%) 
Hyponatraemia * 1  4/3219 (0.12%) 
Tumour lysis syndrome * 1  1/3219 (0.03%) 
Decreased appetite * 1  1/3219 (0.03%) 
Hypoglycaemia * 1  4/3219 (0.12%) 
Type 2 diabetes mellitus * 1  1/3219 (0.03%) 
Electrolyte imbalance * 1  1/3219 (0.03%) 
Hypertriglyceridaemia * 1  1/3219 (0.03%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  12/3219 (0.37%) 
Back pain * 1  6/3219 (0.19%) 
Bursitis * 1  1/3219 (0.03%) 
Muscular weakness * 1  3/3219 (0.09%) 
Musculoskeletal chest pain * 1  3/3219 (0.09%) 
Arthritis * 1  3/3219 (0.09%) 
Myalgia * 1  2/3219 (0.06%) 
Neck pain * 1  1/3219 (0.03%) 
Osteoporosis * 1  1/3219 (0.03%) 
Pathological fracture * 1  1/3219 (0.03%) 
Dupuytren's contracture * 1  1/3219 (0.03%) 
Osteitis * 1  1/3219 (0.03%) 
Pain in extremity * 1  1/3219 (0.03%) 
Spinal pain * 1  1/3219 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma * 1  68/3219 (2.11%) 
Chronic lymphocytic leukaemia * 1  1/3219 (0.03%) 
Fibrous histiocytoma * 1  1/3219 (0.03%) 
Intracranial tumour haemorrhage * 1  7/3219 (0.22%) 
Keratoacanthoma * 1  260/3219 (8.08%) 
Malignant melanoma * 1  43/3219 (1.34%) 
Malignant melanoma in situ * 1  10/3219 (0.31%) 
Melanocytic naevus * 1  2/3219 (0.06%) 
Mycosis fungoides * 1  2/3219 (0.06%) 
Papilloma * 1  4/3219 (0.12%) 
Skin papilloma * 1  3/3219 (0.09%) 
Squamous cell carcinoma of skin * 1  259/3219 (8.05%) 
Tumour haemorrhage * 1  1/3219 (0.03%) 
Tumour ulceration * 1  1/3219 (0.03%) 
Tumour necrosis * 1  1/3219 (0.03%) 
Acanthoma * 1  2/3219 (0.06%) 
Adrenocarcinoma of colon * 1  2/3219 (0.06%) 
Benign neoplasm of skin * 1  1/3219 (0.03%) 
Bowen's disease * 1  5/3219 (0.16%) 
Breast cancer * 1  2/3219 (0.06%) 
Carcinoma in situ of skin * 1  1/3219 (0.03%) 
Cervix carcinoma stage 0 * 1  1/3219 (0.03%) 
Cholesteatoma * 1  1/3219 (0.03%) 
Chondrosarcoma * 1  1/3219 (0.03%) 
Ependymoma * 1  1/3219 (0.03%) 
Eye naevus * 1  1/3219 (0.03%) 
Infected neoplasm * 1  1/3219 (0.03%) 
Intraductal proliferative breast lesion * 1  1/3219 (0.03%) 
Invasive ductal breast carcinoma * 1  1/3219 (0.03%) 
Kaposi's sarcoma * 1  1/3219 (0.03%) 
Lymphoma * 1  1/3219 (0.03%) 
Myxoid liposarcoma * 1  1/3219 (0.03%) 
Neoplasm * 1  1/3219 (0.03%) 
Neuroendocrine carcinoma * 1  1/3219 (0.03%) 
Neuroendocrine carcinoma of the skin * 1  1/3219 (0.03%) 
Neuroendocrine tumour * 1  1/3219 (0.03%) 
Oral papilloma * 1  1/3219 (0.03%) 
Pancreatic carcinoma * 1  2/3219 (0.06%) 
Rectal cancer * 1  1/3219 (0.03%) 
Seborrhoeic keratosis * 1  1/3219 (0.03%) 
Skin neoplasm bleeding * 1  1/3219 (0.03%) 
Squamous cell carcinoma of the oral cavity * 1  1/3219 (0.03%) 
Squamous cell carcinoma of the vulva * 1  1/3219 (0.03%) 
Superficial spreading melanoma stage unspecified * 1  1/3219 (0.03%) 
Synovial sarcoma * 1  1/3219 (0.03%) 
Transitional cell carcinoma * 1  2/3219 (0.06%) 
Tumour associated fever * 1  1/3219 (0.03%) 
Lentigo maligna * 1  1/3219 (0.03%) 
Nervous system disorders   
Brain oedema * 1  3/3219 (0.09%) 
Cerebral haematoma * 1  3/3219 (0.09%) 
Cerebral haemorrhage * 1  14/3219 (0.43%) 
Cerebrovascular accident * 1  10/3219 (0.31%) 
Cognitive disorder * 1  3/3219 (0.09%) 
Depressed level of consciousness * 1  1/3219 (0.03%) 
Dizziness * 1  3/3219 (0.09%) 
Dysarthria * 1  2/3219 (0.06%) 
Epilepsy * 1  10/3219 (0.31%) 
Facial paresis * 1  1/3219 (0.03%) 
Generalised tonic clonic seizure * 1  1/3219 (0.03%) 
Haemorrhage intracranial * 1  3/3219 (0.09%) 
Haemorrhagic stroke * 1  1/3219 (0.03%) 
Headache * 1  3/3219 (0.09%) 
Intracranial pressure increased * 1  1/3219 (0.03%) 
Hydrocephalus * 1  2/3219 (0.06%) 
Ischaemic stroke * 1  2/3219 (0.06%) 
Nervous system disorder * 1  1/3219 (0.03%) 
Neuralgia * 1  2/3219 (0.06%) 
Neuropathy peripheral * 1  1/3219 (0.03%) 
Sciatica * 1  1/3219 (0.03%) 
Stupor * 1  1/3219 (0.03%) 
Syncope * 1  2/3219 (0.06%) 
Transient ischaemic attack * 1  2/3219 (0.06%) 
Tremor * 1  1/3219 (0.03%) 
VIIth nerve paralysis * 1  2/3219 (0.06%) 
Aphasia * 1  1/3219 (0.03%) 
Balance disorder * 1  1/3219 (0.03%) 
Carpal tunnel syndrome * 1  1/3219 (0.03%) 
Cerebral disorder * 1  1/3219 (0.03%) 
Cerebrospinal fluid leakage * 1  1/3219 (0.03%) 
Facial nerve disorder * 1  1/3219 (0.03%) 
Metabolic encephalopathy * 1  1/3219 (0.03%) 
Migraine * 1  2/3219 (0.06%) 
Monoplegia * 1  1/3219 (0.03%) 
Neurotoxicity * 1  1/3219 (0.03%) 
Partial seizures * 1  1/3219 (0.03%) 
Peripheral sensorimotor neuropathy * 1  2/3219 (0.06%) 
Polyneuropathy * 1  1/3219 (0.03%) 
Seizure * 1  12/3219 (0.37%) 
Simple partial seizure * 1  1/3219 (0.03%) 
Spinal cord compression * 1  3/3219 (0.09%) 
Status epilepticus * 1  1/3219 (0.03%) 
Subarachnoid haemorrhage * 1  1/3219 (0.03%) 
Vasogenic cerebral oedema * 1  1/3219 (0.03%) 
Cerebellar infarction * 1  1/3219 (0.03%) 
Psychiatric disorders   
Anxiety * 1  3/3219 (0.09%) 
Completed suicide * 1  2/3219 (0.06%) 
Confusional state * 1  5/3219 (0.16%) 
Psychotic disorder * 1  2/3219 (0.06%) 
Suicidal ideation * 1  1/3219 (0.03%) 
Bipolar disorder * 1  1/3219 (0.03%) 
Delirium * 1  3/3219 (0.09%) 
Mania * 1  1/3219 (0.03%) 
Mood altered * 1  2/3219 (0.06%) 
Renal and urinary disorders   
Calculus ureteric * 1  2/3219 (0.06%) 
Glomerulonephritis minimal lesion * 1  1/3219 (0.03%) 
Haematuria * 1  3/3219 (0.09%) 
Renal colic * 1  2/3219 (0.06%) 
Urinary tract disorder * 1  1/3219 (0.03%) 
Acute kidney injury * 1  8/3219 (0.25%) 
Nephrolithiasis * 1  1/3219 (0.03%) 
Nephropathy * 1  1/3219 (0.03%) 
Nephhropathy toxic * 1  1/3219 (0.03%) 
Tubulointerstitial nephritis * 1  1/3219 (0.03%) 
Urinary fistula * 1  1/3219 (0.03%) 
Reproductive system and breast disorders   
Cervical polyp * 1  1/3219 (0.03%) 
Uterine haemorrhage * 1  1/3219 (0.03%) 
Adnexal torsion * 1  1/3219 (0.03%) 
Endometrial hyperplasia * 1  1/3219 (0.03%) 
Metrorrhagia * 1  1/3219 (0.03%) 
Peyronie's disease * 1  1/3219 (0.03%) 
Uterine cervical erosion * 1  1/3219 (0.03%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome * 1  1/3219 (0.03%) 
Acute respiratory failure * 1  4/3219 (0.12%) 
Chronic obstructive pulmonary disease * 1  4/3219 (0.12%) 
Dyspnoea * 1  4/3219 (0.12%) 
Epistaxis * 1  1/3219 (0.03%) 
Haemoptysis * 1  2/3219 (0.06%) 
Pleural effusion * 1  6/3219 (0.19%) 
Pneumothorax * 1  1/3219 (0.03%) 
Pulmonary embolism * 1  13/3219 (0.40%) 
Respiratory failure * 1  1/3219 (0.03%) 
Acute Pulmonary Oedema * 1  2/3219 (0.06%) 
Bronchial haemorrhage * 1  1/3219 (0.03%) 
Hydrothorax * 1  1/3219 (0.03%) 
Pleurisy * 1  1/3219 (0.03%) 
Pleuritic pain * 1  1/3219 (0.03%) 
Pneumonitis * 1  1/3219 (0.03%) 
Pulmonary toxicity * 1  2/3219 (0.06%) 
Vocal cord leukoplakia * 1  1/3219 (0.03%) 
Skin and subcutaneous tissue disorders   
Acanthosis * 1  4/3219 (0.12%) 
Actinic keratosis * 1  9/3219 (0.28%) 
Angioedema * 1  2/3219 (0.06%) 
Dermatitis exfoliative * 1  3/3219 (0.09%) 
Hypersensitivity vasculitis * 1  1/3219 (0.03%) 
Photosensitivity reaction * 1  5/3219 (0.16%) 
Rash * 1  5/3219 (0.16%) 
Rash maculo-papular * 1  7/3219 (0.22%) 
Rash pruritic * 1  1/3219 (0.03%) 
Skin mass * 1  1/3219 (0.03%) 
Toxic epidermal necrolysis * 1  3/3219 (0.09%) 
Lichenoid keratosis * 1  1/3219 (0.03%) 
Dermal cyst * 1  1/3219 (0.03%) 
Dermatitis exfoliative generalised * 1  1/3219 (0.03%) 
Drug eruption * 1  2/3219 (0.06%) 
Drug reaction with eosinophilia and systemic symptoms * 1  2/3219 (0.06%) 
Erythema nodosum * 1  1/3219 (0.03%) 
Hyperkeratosis * 1  1/3219 (0.03%) 
Panniculitis * 1  2/3219 (0.06%) 
Rash erythematous * 1  1/3219 (0.03%) 
Rash follicular * 1  1/3219 (0.03%) 
Rash generalised * 1  2/3219 (0.06%) 
Rash macular * 1  1/3219 (0.03%) 
Rash papular * 1  1/3219 (0.03%) 
Stevens-Johnson syndrome * 1  1/3219 (0.03%) 
Vascular disorders   
Intermittent claudication * 1  1/3219 (0.03%) 
Extremity necrosis * 1  1/3219 (0.03%) 
Hypotension * 1  1/3219 (0.03%) 
Thrombophlebitis * 1  1/3219 (0.03%) 
Circulatory collapse * 1  1/3219 (0.03%) 
Deep vein thrombosis * 1  2/3219 (0.06%) 
Haematoma * 1  1/3219 (0.03%) 
Hypertension * 1  2/3219 (0.06%) 
Hypertensive Crisis * 1  2/3219 (0.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vemurafenib
Affected / at Risk (%)
Total   2956/3219 (91.83%) 
Blood and lymphatic system disorders   
Anaemia * 1  215/3219 (6.68%) 
Gastrointestinal disorders   
Diarrhoea * 1  584/3219 (18.14%) 
Nausea * 1  718/3219 (22.31%) 
Vomiting * 1  449/3219 (13.95%) 
Abdominal Pain * 1  170/3219 (5.28%) 
Constipation * 1  196/3219 (6.09%) 
General disorders   
Fatigue * 1  834/3219 (25.91%) 
Pyrexia * 1  363/3219 (11.28%) 
Asthenia * 1  382/3219 (11.87%) 
Oedema Peripheral * 1  238/3219 (7.39%) 
Infections and infestations   
Conjunctivitis * 1  170/3219 (5.28%) 
Nasopharyngitis * 1  171/3219 (5.31%) 
Injury, poisoning and procedural complications   
Sunburn * 1  318/3219 (9.88%) 
Investigations   
Weight decreased * 1  414/3219 (12.86%) 
Electrocardiogram QT prolonged * 1  521/3219 (16.19%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  482/3219 (14.97%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1357/3219 (42.16%) 
Myalgia * 1  308/3219 (9.57%) 
Back Pain * 1  191/3219 (5.93%) 
Muscloskeletal Pain * 1  222/3219 (6.90%) 
Pain in Extremity * 1  276/3219 (8.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma * 1  621/3219 (19.29%) 
Melanocytic naevus * 1  227/3219 (7.05%) 
Seborrhoeic keratosis * 1  266/3219 (8.26%) 
Nervous system disorders   
Headache * 1  458/3219 (14.23%) 
Dysgeusia * 1  191/3219 (5.93%) 
Psychiatric disorders   
Insomnia * 1  163/3219 (5.06%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  191/3219 (5.93%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  873/3219 (27.12%) 
Dry skin * 1  538/3219 (16.71%) 
Erythema * 1  327/3219 (10.16%) 
Hyperkeratosis * 1  830/3219 (25.78%) 
Photosensitivity reaction * 1  678/3219 (21.06%) 
Pruritus * 1  320/3219 (9.94%) 
Rash * 1  556/3219 (17.27%) 
Actinic keratosis * 1  246/3219 (7.64%) 
Palmar plantar erythrodysaesthesia syndrome * 1  193/3219 (6.00%) 
Rash erythematous * 1  195/3219 (6.06%) 
Rash Maculo- Papular * 1  179/3219 (5.56%) 
Vascular disorders   
Hypertension * 1  264/3219 (8.20%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01307397     History of Changes
Other Study ID Numbers: MO25515
2010-023526-21 ( EudraCT Number )
First Submitted: February 17, 2011
First Posted: March 2, 2011
Results First Submitted: July 21, 2017
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017