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A Study of Vemurafenib in Previously Treated Patients 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: NCT00949702
Recruitment Status : Completed
First Posted : July 30, 2009
Results First Posted : December 22, 2011
Last Update Posted : July 25, 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 132
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 132
Completed 84
Not Completed 48
Reason Not Completed
Death             40
Disease progression             7
Withdrawal of consent             1
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants
50.3  (14.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
Female
51
  38.6%
Male
81
  61.4%
1.Primary Outcome
Title Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Hide Description 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.
Time Frame From first treatment through September 27, 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
52.3
(43.4 to 61.0)
2.Secondary Outcome
Title Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Hide Description 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.
Time Frame From first treatment through September 27, 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
54.5
(45.7 to 63.2)
3.Secondary Outcome
Title Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Hide Description 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.
Time Frame From first treatment through September 27, 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 69
Median (95% Confidence Interval)
Unit of Measure: Months
6.5 [1] 
(5.6 to NA)
[1]
The upper limit of the confidence interval was not estimable because a large percentage of patients (57%) were progression-free at the data cutoff date and had censored data.
4.Secondary Outcome
Title Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Hide Description 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.
Time Frame From first treatment through September 27, 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 69
Median (Inter-Quartile Range)
Unit of Measure: Months
1.38
(1.3 to 1.6)
5.Secondary Outcome
Title Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Hide Description 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.
Time Frame From first treatment through September 27, 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 132
Median (95% Confidence Interval)
Unit of Measure: Months
6.1
(5.5 to 6.9)
6.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame From first treatment through September 27, 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 132
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(9.5 to NA)
[1]
The median and the upper limit of the confidence interval were not estimable because a large percentage of patients (69%) were alive at the data cutoff date.
7.Secondary Outcome
Title 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
Hide Description 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.
Time Frame From first treatment through September 27, 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Improvement in performance status
83.3
(80.0 to 90.0)
Improvement in oxygen saturation requirement
4.5
(0.0 to 10.0)
Decrease in use of narcotic pain analgesics
3.0
(0.0 to 10.0)
8.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1
Hide Description 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).
Time Frame Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Mean (Standard Deviation)
Unit of Measure: μg/mL
56.73  (21.76)
9.Secondary Outcome
Title Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1
Hide Description 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.
Time Frame Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Mean (Standard Deviation)
Unit of Measure: μg⋅h/mL
380.16  (143.56)
10.Secondary Outcome
Title Vemurafenib Plasma Levels at Various Treatment Cycles
Hide Description 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.
Time Frame Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 122
Mean (Standard Deviation)
Unit of Measure: μg/mL
Pre-dose Cycle 1 Day 15, n=108 47.55  (23.14)
Pre-dose Cycle 2 Day 1, n=122 41.12  (23.39)
Pre-dose Cycle 3 Day 1, n=109 45.20  (21.33)
Pre-dose Cycle 4 Day 1, n=109 50.31  (19.52)
Pre-dose Cycle 6 Day 1, n=96 50.38  (19.54)
Pre-dose Cycle 8 Day 1, n=71 50.42  (22.06)
Pre-dose Cycle 10 Day 1, n=50 50.78  (20.19)
4 hours post-dose Cycle 2 Day 22, n=93 48.38  (20.00)
4 hours post-dose Cycle 3 Day 43, n=78 50.79  (19.20)
4 hours post-dose Cycle 4 Day 1, n=75 55.76  (20.57)
4 hours post-dose Cycle 6 Day 1, n=58 58.92  (20.12)
4 hours post-dose Cycle 8 Day 1, n=43 58.95  (20.98)
4 hours post-dose Cycle 10 Day 1, n=27 63.27  (21.52)
11.Secondary Outcome
Title Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)
Hide Description 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.
Time Frame Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Electrocardiogram (ECG) evaluable population: All treated patients who had a baseline ECG and at least one ECG during treatment.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 128
Mean (95% Confidence Interval)
Unit of Measure: ms
Cycle 1 Day 15 at 2 hours post-dose, n=109
12.8 [1] 
(NA to 14.9)
Cycle 6 Day 1 at pre-dose, n=85
15.1 [1] 
(NA to 17.7)
[1]
This is a one-sided confidence interval.
12.Secondary Outcome
Title Percentage of Patients With Adverse Event
Hide Description 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).
Time Frame From first treatment through September 27, 2010
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 132
Measure Type: Number
Unit of Measure: Percentage of participants
100.0
Time Frame Screening through 6 months after the last patient enrolled
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vemurafenib 960 mg
Hide Arm/Group Description 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.
All-Cause Mortality
Vemurafenib 960 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vemurafenib 960 mg
Affected / at Risk (%)
Total   67/132 (50.76%) 
Blood and lymphatic system disorders   
ANAEMIA  1  1/132 (0.76%) 
Cardiac disorders   
PERICARDIAL EFFUSION  1  2/132 (1.52%) 
ANGINA PECTORIS  1  1/132 (0.76%) 
PERICARDITIS  1  1/132 (0.76%) 
ATRIAL FLUTTER  1  1/132 (0.76%) 
Eye disorders   
RETINAL VEIN OCCLUSION  1  1/132 (0.76%) 
Gastrointestinal disorders   
DYSPHAGIA  1  3/132 (2.27%) 
ABDOMINAL PAIN UPPER  1  2/132 (1.52%) 
NAUSEA  1  2/132 (1.52%) 
ABDOMINAL PAIN  1  1/132 (0.76%) 
DIARRHOEA  1  1/132 (0.76%) 
GASTROINTESTINAL HAEMORRHAGE  1  1/132 (0.76%) 
OESOPHAGITIS  1  1/132 (0.76%) 
PANCREATITIS  1  1/132 (0.76%) 
VOMITING  1  1/132 (0.76%) 
General disorders   
PYREXIA  1  3/132 (2.27%) 
MULTI-ORGAN FAILURE  1  1/132 (0.76%) 
PAIN  1  1/132 (0.76%) 
Hepatobiliary disorders   
CHOLECYSTITIS  1  1/132 (0.76%) 
HEPATIC CYST  1  1/132 (0.76%) 
JAUNDICE  1  1/132 (0.76%) 
Infections and infestations   
PNEUMONIA  1  3/132 (2.27%) 
CELLULITIS  1  2/132 (1.52%) 
BREAST CELLULITIS  1  1/132 (0.76%) 
PSEUDOMONAS INFECTION  1  1/132 (0.76%) 
SALMONELLOSIS  1  1/132 (0.76%) 
SKIN INFECTION  1  1/132 (0.76%) 
STAPHYLOCOCCAL INFECTION  1  1/132 (0.76%) 
WOUND INFECTION  1  1/132 (0.76%) 
Injury, poisoning and procedural complications   
FEMUR FRACTURE  1  1/132 (0.76%) 
Investigations   
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  3/132 (2.27%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  2/132 (1.52%) 
BLOOD BILIRUBIN INCREASED  1  2/132 (1.52%) 
ALANINE AMINOTRANSFERASE INCREASED  1  1/132 (0.76%) 
BILIRUBIN CONJUGATED INCREASED  1  1/132 (0.76%) 
Metabolism and nutrition disorders   
DEHYDRATION  1  2/132 (1.52%) 
TUMOUR LYSIS SYNDROME  1  1/132 (0.76%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  2/132 (1.52%) 
ARTHRITIS  1  1/132 (0.76%) 
MUSCULAR WEAKNESS  1  1/132 (0.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
SQUAMOUS CELL CARCINOMA OF SKIN  1  28/132 (21.21%) 
BASAL CELL CARCINOMA  1  8/132 (6.06%) 
KERATOACANTHOMA  1  6/132 (4.55%) 
MALIGNANT MELANOMA  1  2/132 (1.52%) 
Nervous system disorders   
CONVULSION  1  3/132 (2.27%) 
FACIAL PALSY  1  3/132 (2.27%) 
Psychiatric disorders   
DELIRIUM  1  1/132 (0.76%) 
PSYCHOTIC DISORDER  1  1/132 (0.76%) 
Renal and urinary disorders   
RENAL FAILURE  1  1/132 (0.76%) 
RENAL FAILURE ACUTE  1  1/132 (0.76%) 
Respiratory, thoracic and mediastinal disorders   
PULMONARY EMBOLISM  1  3/132 (2.27%) 
DYSPNOEA  1  1/132 (0.76%) 
RESPIRATORY FAILURE  1  1/132 (0.76%) 
LEFT LUNG GROUND GLASS OPACITIES-PNEUMONITIS  1  1/132 (0.76%) 
Skin and subcutaneous tissue disorders   
EXFOLIATIVE RASH  1  1/132 (0.76%) 
RASH  1  1/132 (0.76%) 
RASH VESICULAR  1  1/132 (0.76%) 
Vascular disorders   
DEEP VEIN THROMBOSIS  1  1/132 (0.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vemurafenib 960 mg
Affected / at Risk (%)
Total   131/132 (99.24%) 
Blood and lymphatic system disorders   
ANAEMIA  1  11/132 (8.33%) 
Eye disorders   
VISION BLURRED  1  7/132 (5.30%) 
Gastrointestinal disorders   
NAUSEA  1  47/132 (35.61%) 
DIARRHOEA  1  37/132 (28.03%) 
VOMITING  1  33/132 (25.00%) 
CONSTIPATION  1  21/132 (15.91%) 
ABDOMINAL PAIN  1  12/132 (9.09%) 
DYSPEPSIA  1  11/132 (8.33%) 
General disorders   
FATIGUE  1  71/132 (53.79%) 
OEDEMA PERIPHERAL  1  30/132 (22.73%) 
PYREXIA  1  20/132 (15.15%) 
CHILLS  1  9/132 (6.82%) 
PAIN  1  7/132 (5.30%) 
Infections and infestations   
FOLLICULITIS  1  12/132 (9.09%) 
UPPER RESPIRATORY TRACT INFECTION  1  8/132 (6.06%) 
NASOPHARYNGITIS  1  7/132 (5.30%) 
Injury, poisoning and procedural complications   
SUNBURN  1  19/132 (14.39%) 
Investigations   
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  17/132 (12.88%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  10/132 (7.58%) 
ALANINE AMINOTRANSFERASE INCREASED  1  8/132 (6.06%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  7/132 (5.30%) 
BLOOD CREATININE INCREASED  1  12/132 (9.09%) 
LYMPHOCYTE COUNT DECREASED  1  7/132 (5.30%) 
BLOOD BILIRUBIN INCREASED  1  7/132 (5.30%) 
WEIGHT DECREASED  1  12/132 (9.09%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  28/132 (21.21%) 
HYPOKALAEMIA  1  10/132 (7.58%) 
HYPERGLYCAEMIA  1  7/132 (5.30%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  86/132 (65.15%) 
MYALGIA  1  31/132 (23.48%) 
MUSCULOSKELETAL PAIN  1  15/132 (11.36%) 
BACK PAIN  1  14/132 (10.61%) 
ARTHRITIS  1  12/132 (9.09%) 
PAIN IN EXTREMITY  1  12/132 (9.09%) 
JOINT SWELLING  1  7/132 (5.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
MELANOCYTIC NAEVUS  1  7/132 (5.30%) 
Nervous system disorders   
HEADACHE  1  36/132 (27.27%) 
DYSGEUSIA  1  14/132 (10.61%) 
NEUROPATHY PERIPHERAL  1  13/132 (9.85%) 
DIZZINESS  1  8/132 (6.06%) 
Psychiatric disorders   
DEPRESSION  1  11/132 (8.33%) 
INSOMNIA  1  9/132 (6.82%) 
ANXIETY  1  7/132 (5.30%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  16/132 (12.12%) 
OROPHARYNGEAL PAIN  1  13/132 (9.85%) 
DYSPNOEA  1  10/132 (7.58%) 
Skin and subcutaneous tissue disorders   
RASH  1  68/132 (51.52%) 
PHOTOSENSITIVITY REACTION  1  65/132 (49.24%) 
ALOPECIA  1  47/132 (35.61%) 
PRURITUS  1  40/132 (30.30%) 
SKIN PAPILLOMA  1  39/132 (29.55%) 
HYPERKERATOSIS  1  37/132 (28.03%) 
RASH MACULO-PAPULAR  1  27/132 (20.45%) 
ACTINIC KERATOSIS  1  22/132 (16.67%) 
DRY SKIN  1  21/132 (15.91%) 
RASH PAPULAR  1  17/132 (12.88%) 
KERATOSIS PILARIS  1  12/132 (9.09%) 
ERYTHEMA  1  11/132 (8.33%) 
PALMAR-PLANTAR  1  11/132 (8.33%) 
ERYTHRODYSAESTHESIA SYNDROME ACNE  1  10/132 (7.58%) 
DERMATITIS ACNEIFORM  1  9/132 (6.82%) 
SKIN EXFOLIATION  1  8/132 (6.06%) 
SKIN LESION  1  8/132 (6.06%) 
SEBORRHOEIC KERATOSIS  1  19/132 (14.39%) 
ACNE  1  10/132 (7.58%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00949702     History of Changes
Other Study ID Numbers: NP22657
First Submitted: July 28, 2009
First Posted: July 30, 2009
Results First Submitted: July 29, 2011
Results First Posted: December 22, 2011
Last Update Posted: July 25, 2017