Trial Outcomes & Findings for A Study of RO5185426 in Patients With Metastatic Melanoma (NCT NCT01248936)

Last Updated: 2016-08-12

Results Overview

An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded according to the 'National Cancer Institute Common Terminology Criteria for Adverse Events' (NCI CTCAE, v4.0). However Laboratory data will be summarized by grade using the NCI CTCAE, v4.0 toxicity grade.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

374 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2016-08-12

Participant Flow

The study was conducted in 29 study sites in the United States (US). The study period was from 10 December 2010 to 24 October 2011.

Overall, 745 participants were screened during the study, of which 374 were enrolled to receive study treatment; the main reason for screen failure was negative cobas test, consent withdrawal, BRAF test not performed, patient died or progressed, and other unspecified reasons. Of 374 participants, 3 did not receive treatment after enrollment.

Participant milestones

Participant milestones
Measure	Overall Trial Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
Overall Study STARTED	374
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	374

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Trial Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
Overall Study Sponsor Decision	259
Overall Study Progression of Disease	50
Overall Study Death	26
Overall Study Withdrawal of Consent	20
Overall Study Adverse Event	8
Overall Study Lost to Follow-up	7
Overall Study Refused Treatment	1
Overall Study Other reason	3

Baseline Characteristics

A Study of RO5185426 in Patients With Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Trial n=371 Participants Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
Age, Continuous	53.5 years STANDARD_DEVIATION 13.8 • n=5 Participants
Age, Customized Adolescents (12-17 year)	1 participants n=5 Participants
Age, Customized From 18 - 64 years	289 participants n=5 Participants
Age, Customized From 65 - 84 years	79 participants n=5 Participants
Age, Customized Over 85 years	2 participants n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants
Sex: Female, Male Male	229 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.

Outcome measures

Outcome measures
Measure	Overall Trial n=371 Participants Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation Any AE	346 participants
Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation Grade 3 AEs	115 participants
Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation Grade 4 AEs	15 participants
Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation Grade 5 AEs	7 participants
Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation AEs leading to discontinuation	9 participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.

Serious Adverse Event (SAEs) is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Number of participants who died and the cause of death are also recorded.

Outcome measures

Outcome measures
Measure	Overall Trial n=371 Participants Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Number of Participants With Any Serious Adverse Event, Death and Cause of Death All Deaths	43 participants
Number of Participants With Any Serious Adverse Event, Death and Cause of Death Death due to progression of disease	22 participants
Number of Participants With Any Serious Adverse Event, Death and Cause of Death Death due to adverse event	8 participants
Number of Participants With Any Serious Adverse Event, Death and Cause of Death Deaths which are not related to study drug	6 participants
Number of Participants With Any Serious Adverse Event, Death and Cause of Death Deaths which are related to study drug	2 participants
Number of Participants With Any Serious Adverse Event, Death and Cause of Death Any SAEs	83 participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.

The best overall response (unconfirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed. Participants were assessed for best overall response by investigator as per 'Response Evaluation Criteria in Solid Tumors' (RECIST v1.1).

Outcome measures

Outcome measures
Measure	Overall Trial n=241 Participants Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Number of Participants With Best Overall Response (Unconfirmed)	129 participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: The efficacy population was defined as treated patients who had measurable disease at baseline and at least one post-baseline tumor assessment.

The best overall response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. This endpoint was tumor response category according to investigator assessment per RECIST v1.1 for efficacy assessment. The 'n' is number of participants with ECOG performance status in each criteria.

Outcome measures

Outcome measures
Measure	Overall Trial n=241 Participants Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance ECOG performance status 2 or 3; n=31	13 Participants
Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance ECOG performance status 0 or 1; n=210	116 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.

The best overall response (confirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was confirmed. Participants were assessed for best overall response by investigator as per RECIST v1.1.

Outcome measures

Outcome measures
Measure	Overall Trial n=241 Participants Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Number of Participants With Best Overall Response (Confirmed)	26 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.

The best overall response recorded from the start of the treatment until disease progression/recurrence which was confirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants were assessed for best overall response by investigator as per RECIST v1.1. The 'n' is number of participants with ECOG performance status in each criteria.

Outcome measures

Outcome measures
Measure	Overall Trial n=241 Participants Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Number of Participants With Best Overall Response (Confirmed) by ECOG Performance ECOG performance status 2 or 3); n= 31	1 Participants
Number of Participants With Best Overall Response (Confirmed) by ECOG Performance ECOG performance status 0 or 1); n= 210	25 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.

Mean time to Complete Response (CR)/Partial Response(PR) (confirmed or unconfirmed was assessed). Participants were assessed for best overall response by investigator as per RECIST v1.1.

Outcome measures

Outcome measures
Measure	Overall Trial n=241 Participants Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Mean Time to Complete Response/Partial Response Mean time to confirmed CR or PR	1.8 Months Standard Deviation 0.3
Mean Time to Complete Response/Partial Response Mean time to unconfirmed CR or PR	2.0 Months Standard Deviation 0.7

Adverse Events

Overall Trial

Serious events: 83 serious events

Other events: 308 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Overall Trial n=371 participants at risk Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Gastrointestinal disorders Vomiting	1.3% 5/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Abdominal Pain	0.81% 3/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Nausea	0.54% 2/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Ascites	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Constipation	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Diverticular Perforation	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Gastric Ulcer	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Small Intestinal Obstruction	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Infections and infestations Cellulitis	1.1% 4/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Infections and infestations Urinary Tract Infection	1.1% 4/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Infections and infestations Pneumonia	0.81% 3/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Infections and infestations Bacterial Infection	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Infections and infestations Clostridial infection	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Infections and infestations Sepsis	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Pyrexia	1.3% 5/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Death	0.54% 2/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Asthenia	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Chest Pain	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Drug Withdrawal Syndrome	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Fatigue	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Multi-organ failure	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Pain	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Nervous system disorders Convulsion	1.3% 5/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Nervous system disorders Headache	0.54% 2/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Nervous system disorders Cerebral haemorrhage	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Nervous system disorders Hydrocephalus	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Nervous system disorders Lethargy	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Nervous system disorders Lumbar Radiculopathy	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Nervous system disorders Paraesthesia	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Nervous system disorders Spinal Cord Compression	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Dehydration	1.3% 5/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hyperkalaemia	0.54% 2/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Failure To Thrive	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hypokalaemia	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.81% 3/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.81% 3/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.54% 2/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Investigations Electrocardiogram Qt Prolonged	0.81% 3/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Investigations Blood Bilirubin Increased	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Investigations Blood Creatine Phosphokinase Increased	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Investigations Blood Uric Acid Increased	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Investigations Neutrophil count decreased	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Arthralgia	0.54% 2/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Neck Pain	0.54% 2/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Back Pain	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Psychiatric disorders Confusional State	0.81% 3/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Psychiatric disorders Mental Status Changes	0.54% 2/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Psychiatric disorders Paranoia	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Anaemia	0.81% 3/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Lymphopenia	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Neutropenia	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Angioedema	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Dermatitis	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Photosensitivity Reaction	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Rash	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Cardiac disorders Atrial Flutter	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Cardiac disorders Cardiac failure congestive	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Cardiac disorders Pericardial Effusion	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Procedural pain	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Spinal compression fracture	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Toxicity to various agents	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Renal and urinary disorders Renal Colic	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Renal and urinary disorders Renal Failure	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Renal and urinary disorders Renal Failure Acute	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Eye disorders Pupils unequal	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Eye disorders Uveitis	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Hepatobiliary disorders Hyperbilirubinaemia	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Central Nervous System	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Reproductive system and breast disorders Female genital tract fistula	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Vascular disorders Deep Vein Thrombosis	0.27% 1/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.

Other adverse events

Other adverse events
Measure	Overall Trial n=371 participants at risk Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Skin and subcutaneous tissue disorders Rash	27.5% 102/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Photosensitivity Reaction	16.7% 62/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Alopecia	11.1% 41/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Hyperkeratosis	7.8% 29/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Dry Skin	7.0% 26/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	6.2% 23/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Pruritus	9.7% 36/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Arthralgia	36.7% 136/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Myalgia	8.1% 30/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Pain In Extremity	5.4% 20/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Fatigue	27.5% 102/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Oedema Peripheral	11.1% 41/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
General disorders Pyrexia	10.0% 37/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Nausea	18.6% 69/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Diarrhoea	11.3% 42/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Vomiting	8.1% 30/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Gastrointestinal disorders Constipation	5.4% 20/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Sunburn	12.9% 48/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Skin	6.7% 25/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	6.2% 23/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Decreased Appetite	11.3% 42/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Nervous system disorders Headache	10.0% 37/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Investigations Weight decreased	7.3% 27/371 • Up to 1 Year Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER