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Trial record 36 of 78 for:    vismodegib

STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01367665
Recruitment Status : Completed
First Posted : June 7, 2011
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Basal Cell Carcinoma
Intervention Drug: vismodegib
Enrollment 1232
Recruitment Details  
Pre-assignment Details A total of 1232 participants were enrolled in the study, but only 1215 received at least one dose of any study treatment. Results include only the treated 1215 participants. Not Done category includes participants who did not complete the final end of study completion CRF page, including those who withdrew due to termination of the study.
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Period Title: Overall Study
Started 1119 96
Completed 677 41
Not Completed 442 55
Reason Not Completed
Death             102             19
Lost to Follow-up             222             22
Not Done             118             14
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic Total
Hide Arm/Group Description Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. Total of all reporting groups
Overall Number of Baseline Participants 1119 96 1215
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1119 participants 96 participants 1215 participants
69.7  (16.1) 66.6  (13.0) 69.5  (15.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1119 participants 96 participants 1215 participants
Female
485
  43.3%
36
  37.5%
521
  42.9%
Male
634
  56.7%
60
  62.5%
694
  57.1%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Race: : Asian Number Analyzed 1118 participants 96 participants 1214 participants
1 0 1
Race: : Black or African American Number Analyzed 1118 participants 96 participants 1214 participants
1 1 2
Race: : White Number Analyzed 1118 participants 96 participants 1214 participants
787 92 879
Race: : Other Number Analyzed 1118 participants 96 participants 1214 participants
15 0 15
Race: : Not Applicable Number Analyzed 1118 participants 96 participants 1214 participants
314 3 317
[1]
Measure Analysis Population Description: Race data was not collected for participants enrolled from France as per local regulations.
1.Primary Outcome
Title Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs)
Hide Description Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1119 96
Measure Type: Number
Unit of Measure: percentage of participants
Any AEs 98.4 99.0
Any AEs with maximum severity of Grade 3 or 4 43.4 52.1
Any Serious AEs 24.3 32.3
Any AEs leading to study drug interruption 40.5 35.4
Any AEs leading to study drug discontinuation 33.8 17.7
2.Primary Outcome
Title Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons
Hide Description Reasons for “other” included “unknown,” “natural causes,” “cardiac decompensation,” “general state alteration,” “deterioration of general state,” “clinical deterioration taking into consideration patient’s age,” “old age,” and “disease progression of mediastinal squamous cell carcinoma (SCC).”
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1119 96
Measure Type: Number
Unit of Measure: percentage of participants
Adverse Event 6.1 6.3
Disease Progression 1.9 13.5
Other 1.3 0
3.Primary Outcome
Title Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters
Hide Description [Not Specified]
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1119 96
Measure Type: Number
Unit of Measure: percentage of participants
Hemoglobin (High) 0.1 0
Hemoglobin (Low) 1.3 2.1
Neutrophils, Total, Abs (Low) 0.5 0
Platelet (Low) 0.2 0
White Blood Cell Count (High) 0.2 1.0
White Blood Cell Count (Low) 0.2 0
Alkaline Phosphatase (High) 0.6 0
SGPT/ALT (alanine aminotransferase) - High 2.2 4.2
SGOT/AST (aspartate aminotransferase) - High 1.5 3.1
Creatine Kinase (High) 0.1 0
Creatinine (High) 1.3 2.1
Glucose (Low) 0.4 0
Potassium (High 1.1 4.2
Potassium (Low) 0.8 1.0
Sodium (High) 0.2 0
Sodium (Low) 2.6 4.2
Total Bilirubin (High) 0.4 0
4.Primary Outcome
Title Exposure to Study Treatment: Duration on Treatment
Hide Description Duration on treatment was the number of days between first and last dose of study treatment.
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1119 96
Median (Full Range)
Unit of Measure: days
256.0
(2 to 1904)
337.0
(2 to 1932)
5.Primary Outcome
Title Exposure to Study Treatment - Dose Intensity
Hide Description Dose intensity was defined as the percentage of actual number of doses received versus planned.
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1119 96
Median (Full Range)
Unit of Measure: percentage of doses
97.62
(44.9 to 100.0)
98.51
(67.8 to 100.0)
6.Secondary Outcome
Title Best Overall Response Rate (BORR)
Hide Description BORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) required a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Only included participants that had histologically confirmed measurable disease at baseline.
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1076 83
Measure Type: Number
Unit of Measure: percentage of participants
CR 33.9 4.8
PR 35.3 32.5
7.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of disease progression or death for any cause. Median duration of response was estimated using Kaplan-Meier estimates.
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Only included participants that had histologically confirmed disease, measureable disease status at baseline (measureable or non-measureable) and reported a response of CR or PR.
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1103 89
Median (95% Confidence Interval)
Unit of Measure: months
18.89
(17.64 to 22.57)
13.93
(9.23 to 18.50)
8.Secondary Outcome
Title Time to Response
Hide Description Time to response was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occur first).
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Only included participants that had histologically confirmed measurable disease at baseline.
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1076 83
Median (95% Confidence Interval)
Unit of Measure: months
3.65
(2.92 to 3.71)
NA [1] 
(5.49 to NA)
[1]
Not Estimated as the values were not estimable due to insufficient number of events.
9.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time interval between the date of the first therapy and the date of progression or death for any causes, whichever occurs first. Disease progression was assessed by the investigator.
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable).
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1103 89
Median (95% Confidence Interval)
Unit of Measure: months
20.30
(19.38 to 21.82)
12.85
(11.30 to 17.68)
10.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS 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 to the data cut-off of 14 June 2017 (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable).
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1103 89
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median OS and 95% CI were not estimable due to low proportion of events.
11.Secondary Outcome
Title Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom
Hide Description The Skindex-16 questionnaire includes three domains for the assessment of the effects of skin disease on participants' quality of life: symptoms, emotions and function. For each domain, responses from the questionnaire were transformed to a linear scale of 100 varying from 0 (never bothered, i.e., best) to 100 (always bothers, i.e., worst).
Time Frame Baseline to the data cut-off date of 14 June 2017 (up to 6 years).
Hide Outcome Measure Data
Hide Analysis Population Description
Only included participants that had histologically confirmed disease at baseline. For each time point, Number Analyzed refers to patients with non-missing values.
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 1111 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
Emotion: C2D1 (Cycle 2 Day 1) Number Analyzed 604 participants 39 participants
-18.02  (26.12) -8.68  (23.50)
Emotion: C7D1 Number Analyzed 380 participants 25 participants
-26.04  (30.80) -13.14  (33.25)
Emotion: End of Study Number Analyzed 335 participants 18 participants
-24.66  (33.13) 7.76  (27.61)
Function: C2D1 Number Analyzed 603 participants 39 participants
-7.43  (22.18) -1.71  (16.31)
Function: C7D1 Number Analyzed 380 participants 25 participants
-11.09  (26.49) -10.00  (24.74)
Function: End of Study Number Analyzed 334 participants 18 participants
-9.84  (28.03) 4.81  (29.80)
Symptom: C2D1 Number Analyzed 604 participants 39 participants
-9.92  (22.02) -5.06  (23.10)
Symptom: C7D1 Number Analyzed 379 participants 26 participants
-12.03  (24.95) -6.73  (28.92)
Symptom: End of Study Number Analyzed 334 participants 18 participants
-11.85  (27.05) 1.85  (22.15)
12.Secondary Outcome
Title Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale
Hide Description M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when “at their worst” in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours.
Time Frame 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).
Hide Outcome Measure Data
Hide Analysis Population Description
Included only participants who were enrolled after Protocol Version 4 was implemented, had non-missing data and baseline score ≥4. Per protocol, the MDASI measurements were measured in Metastatic patients only.
Arm/Group Title Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of participants
60.0
13.Secondary Outcome
Title Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale
Hide Description M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when “at their worst” in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours.
Time Frame 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).
Hide Outcome Measure Data
Hide Analysis Population Description
Included only participants who were enrolled after Protocol Version 4 was implemented, had non-missing data and average baseline score ≥ 4. Per protocol, the MDASI measurements were measured in Metastatic patients only.
Arm/Group Title Vismodegib - Metastatic
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: Percentage of participants
33.3
Time Frame Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vismodegib - Locally Advanced Vismodegib - Metastatic
Hide Arm/Group Description Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.
All-Cause Mortality
Vismodegib - Locally Advanced Vismodegib - Metastatic
Affected / at Risk (%) Affected / at Risk (%)
Total   103/1119 (9.20%)   19/96 (19.79%) 
Show Serious Adverse Events Hide Serious Adverse Events
Vismodegib - Locally Advanced Vismodegib - Metastatic
Affected / at Risk (%) Affected / at Risk (%)
Total   272/1119 (24.31%)   31/96 (32.29%) 
Blood and lymphatic system disorders     
ANAEMIA  1  4/1119 (0.36%)  1/96 (1.04%) 
PANCYTOPENIA  1  1/1119 (0.09%)  0/96 (0.00%) 
NORMOCHROMATIC NORMOCYTIC ANAEMIA  1  1/1119 (0.09%)  0/96 (0.00%) 
THROMBOCYTOMPENIA  1  1/1119 (0.09%)  0/96 (0.00%) 
Cardiac disorders     
ATRIAL FIBRILLATION  1  3/1119 (0.27%)  0/96 (0.00%) 
ATRIOVENTRICULAR BLOCK FIRST DEGREE  1  1/1119 (0.09%)  0/96 (0.00%) 
CARDIAC ARREST  1  1/1119 (0.09%)  0/96 (0.00%) 
CARDIAC FAILURE CONGESTIVE  1  2/1119 (0.18%)  0/96 (0.00%) 
CARDIO−RESPIRATORY ARREST  1  1/1119 (0.09%)  0/96 (0.00%) 
LEFT VENTRICULAR DILATION  1  1/1119 (0.09%)  0/96 (0.00%) 
MYOCARDIAL INFARCTION  1  8/1119 (0.71%)  1/96 (1.04%) 
MYOCARDIAL ISCHAEMIA  1  1/1119 (0.09%)  0/96 (0.00%) 
SINUS NODE DYSFUNCTION  1  0/1119 (0.00%)  1/96 (1.04%) 
CARDIAC FAILURE  1  3/1119 (0.27%)  0/96 (0.00%) 
ACUTE LEFT VENTRICULAR FAILURE  1  2/1119 (0.18%)  0/96 (0.00%) 
ACUTE MYOCARDIAL INFARCTION  1  1/1119 (0.09%)  1/96 (1.04%) 
ATRIOVENTRICULAR BLOCK COMPLETE  1  2/1119 (0.18%)  0/96 (0.00%) 
ATRIOVENTRICULAR BLOCK SECOND DEGREE  1  1/1119 (0.09%)  0/96 (0.00%) 
CARDIOPULMONARY FAILURE  1  1/1119 (0.09%)  0/96 (0.00%) 
CONGESTIVE CARDIOMYOPATHY  1  1/1119 (0.09%)  0/96 (0.00%) 
Ear and labyrinth disorders     
VERTIGO  1  2/1119 (0.18%)  0/96 (0.00%) 
VERTIGO POSITIONAL  1  1/1119 (0.09%)  0/96 (0.00%) 
Eye disorders     
DIPLOPIA  1  1/1119 (0.09%)  0/96 (0.00%) 
LAGOPHTHALMOS  1  1/1119 (0.09%)  0/96 (0.00%) 
RETINAL ARTERY OCCLUSION  1  1/1119 (0.09%)  0/96 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  1/1119 (0.09%)  0/96 (0.00%) 
DIARRHOEA  1  1/1119 (0.09%)  0/96 (0.00%) 
GASTRIC ULCER HAEMORRHAGE  1  3/1119 (0.27%)  0/96 (0.00%) 
GASTRITIS EROSIVE  1  1/1119 (0.09%)  0/96 (0.00%) 
INGUINAL HERNIA  1  3/1119 (0.27%)  0/96 (0.00%) 
INTESTINAL OBSTRUCTION  1  3/1119 (0.27%)  0/96 (0.00%) 
VOLVULUS  1  0/1119 (0.00%)  1/96 (1.04%) 
PHARYNGO−OESOPHAGEAL DIVERTICULUM  1  1/1119 (0.09%)  0/96 (0.00%) 
NAUSEA  1  2/1119 (0.18%)  0/96 (0.00%) 
PANCREATITIS  1  2/1119 (0.18%)  0/96 (0.00%) 
VOMITING  1  2/1119 (0.18%)  0/96 (0.00%) 
ABDOMINAL INCARCERATED HERNIA  1  1/1119 (0.09%)  0/96 (0.00%) 
CONSTIPATION  1  1/1119 (0.09%)  0/96 (0.00%) 
DUODENAL ULCER  1  0/1119 (0.00%)  1/96 (1.04%) 
DUODENAL ULCER HAEMORRHAGE  1  1/1119 (0.09%)  0/96 (0.00%) 
GASTRIC PERFORATION  1  1/1119 (0.09%)  0/96 (0.00%) 
GASTRIC ULCER  1  3/1119 (0.27%)  0/96 (0.00%) 
GASTRITIS  1  1/1119 (0.09%)  0/96 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/1119 (0.00%)  1/96 (1.04%) 
ILEUS  1  1/1119 (0.09%)  0/96 (0.00%) 
INTESTINAL ISCHAEMIA  1  1/1119 (0.09%)  0/96 (0.00%) 
LOWER GASTROINTESTINAL HAEMORRHAGE  1  1/1119 (0.09%)  0/96 (0.00%) 
PANCREATITIS ACUTE  1  1/1119 (0.09%)  0/96 (0.00%) 
General disorders     
ASTHENIA  1  4/1119 (0.36%)  0/96 (0.00%) 
CHEST PAIN  1  2/1119 (0.18%)  0/96 (0.00%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  11/1119 (0.98%)  1/96 (1.04%) 
MULTIPLE ORGAN DYSFUNCTION SYNDROME  1  1/1119 (0.09%)  0/96 (0.00%) 
SUDDEN DEATH  1  2/1119 (0.18%)  1/96 (1.04%) 
TERMINAL STATE  1  1/1119 (0.09%)  0/96 (0.00%) 
ILL-DEFINED DISORDER  1  2/1119 (0.18%)  0/96 (0.00%) 
PYREXIA  1  2/1119 (0.18%)  0/96 (0.00%) 
CYST  1  1/1119 (0.09%)  0/96 (0.00%) 
DEATH  1  1/1119 (0.09%)  0/96 (0.00%) 
GAIT DISTURBANCE  1  1/1119 (0.09%)  0/96 (0.00%) 
HERNIA  1  1/1119 (0.09%)  0/96 (0.00%) 
IMPAIRED HEALING  1  1/1119 (0.09%)  0/96 (0.00%) 
OEDEMA PERIPHERAL  1  1/1119 (0.09%)  0/96 (0.00%) 
PAIN  1  0/1119 (0.00%)  1/96 (1.04%) 
PERFORMANCE STATUS DECREASED  1  1/1119 (0.09%)  0/96 (0.00%) 
Hepatobiliary disorders     
CHOLELITHIASIS  1  1/1119 (0.09%)  1/96 (1.04%) 
CHOLESTASIS  1  1/1119 (0.09%)  0/96 (0.00%) 
HEPATITIS  1  1/1119 (0.09%)  0/96 (0.00%) 
HEPATOTOXICITY  1  2/1119 (0.18%)  0/96 (0.00%) 
CHOLECYSTITIS ACUTE  1  4/1119 (0.36%)  0/96 (0.00%) 
BILE DUCT OBSTRUCTION  1  1/1119 (0.09%)  0/96 (0.00%) 
BILIARY COLIC  1  1/1119 (0.09%)  0/96 (0.00%) 
BILIARY CYST  1  1/1119 (0.09%)  0/96 (0.00%) 
CHOLANGITIS ACUTE  1  1/1119 (0.09%)  0/96 (0.00%) 
CHOLECYSTITIS  1  1/1119 (0.09%)  0/96 (0.00%) 
DRUG-INDUCED LIVER INJURY  1  1/1119 (0.09%)  0/96 (0.00%) 
HEPATIC MASS  1  1/1119 (0.09%)  0/96 (0.00%) 
HEPATITIS TOXIC  1  1/1119 (0.09%)  0/96 (0.00%) 
HEPATOCELLULAR INJURY  1  1/1119 (0.09%)  0/96 (0.00%) 
Infections and infestations     
ABSCESS  1  2/1119 (0.18%)  0/96 (0.00%) 
APPENDICITIS  1  1/1119 (0.09%)  0/96 (0.00%) 
BACTERIAL INFECTION  1  1/1119 (0.09%)  0/96 (0.00%) 
BRAIN ABSCESS  1  1/1119 (0.09%)  0/96 (0.00%) 
CELLULITIS  1  2/1119 (0.18%)  0/96 (0.00%) 
CLOSTRIDIUM COLITIS  1  1/1119 (0.09%)  1/96 (1.04%) 
CYSTITIS  1  2/1119 (0.18%)  0/96 (0.00%) 
DIVERTICULITIS  1  2/1119 (0.18%)  0/96 (0.00%) 
ENDOCARDITIS BACTERIAL  1  1/1119 (0.09%)  0/96 (0.00%) 
ENTEROCOCCAL SEPSIS  1  0/1119 (0.00%)  1/96 (1.04%) 
GASTROENTERITIS  1  5/1119 (0.45%)  1/96 (1.04%) 
GASTROENTERITIS CLOSTRIDIAL  1  1/1119 (0.09%)  0/96 (0.00%) 
GASTROENTERITIS VIRAL  1  0/1119 (0.00%)  1/96 (1.04%) 
GROIN ABSCESS  1  0/1119 (0.00%)  1/96 (1.04%) 
HERPES ZOSTER  1  3/1119 (0.27%)  0/96 (0.00%) 
INFECTED SKIN ULCER  1  1/1119 (0.09%)  0/96 (0.00%) 
LOCALISED INFECTION  1  1/1119 (0.09%)  0/96 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  2/1119 (0.18%)  0/96 (0.00%) 
PNEUMONIA  1  17/1119 (1.52%)  1/96 (1.04%) 
PYELONEPHRITIS ACUTE  1  1/1119 (0.09%)  0/96 (0.00%) 
SEPSIS  1  3/1119 (0.27%)  0/96 (0.00%) 
SOFT TISSUE INFECTION  1  1/1119 (0.09%)  0/96 (0.00%) 
BRONCHITIS  1  5/1119 (0.45%)  0/96 (0.00%) 
PYELONEPHRITIS  1  4/1119 (0.36%)  0/96 (0.00%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  3/1119 (0.27%)  0/96 (0.00%) 
URINARY TRACT INFECTION  1  3/1119 (0.27%)  0/96 (0.00%) 
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE  1  1/1119 (0.09%)  1/96 (1.04%) 
LUNG INFECTION  1  2/1119 (0.18%)  0/96 (0.00%) 
UROSEPSIS  1  2/1119 (0.18%)  0/96 (0.00%) 
ABSCESS LIMB  1  1/1119 (0.09%)  0/96 (0.00%) 
ACTINOMYCOSIS  1  1/1119 (0.09%)  0/96 (0.00%) 
ACUTE SINUSITIS  1  1/1119 (0.09%)  0/96 (0.00%) 
ENDOPHTHALMITIS  1  1/1119 (0.09%)  0/96 (0.00%) 
ERYSIPELAS  1  1/1119 (0.09%)  0/96 (0.00%) 
GANGRENE  1  1/1119 (0.09%)  0/96 (0.00%) 
INFECTION  1  1/1119 (0.09%)  0/96 (0.00%) 
MENINGITIS BACTERIAL  1  1/1119 (0.09%)  0/96 (0.00%) 
MORGANELLA INFECTION  1  1/1119 (0.09%)  0/96 (0.00%) 
ORBITAL INFECTION  1  1/1119 (0.09%)  0/96 (0.00%) 
PERIORBITAL CELLULITIS  1  1/1119 (0.09%)  0/96 (0.00%) 
PNEUMONIA BACTERIAL  1  1/1119 (0.09%)  0/96 (0.00%) 
SUBCUTANEOUS ABSCESS  1  1/1119 (0.09%)  0/96 (0.00%) 
Injury, poisoning and procedural complications     
EYEBALL AVULSION  1  1/1119 (0.09%)  0/96 (0.00%) 
FALL  1  8/1119 (0.71%)  0/96 (0.00%) 
FEMORAL NECK FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
FEMUR FRACTURE  1  2/1119 (0.18%)  0/96 (0.00%) 
FOREIGN BODY  1  1/1119 (0.09%)  0/96 (0.00%) 
HIP FRACTURE  1  6/1119 (0.54%)  0/96 (0.00%) 
INCISIONAL HERNIA  1  1/1119 (0.09%)  0/96 (0.00%) 
PROCEDURAL INTESTINAL PERFORATION  1  1/1119 (0.09%)  0/96 (0.00%) 
TRAUMATIC HAEMATOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
SUBDURAL HAEMATOMA  1  2/1119 (0.18%)  0/96 (0.00%) 
ABDOMINAL WOUND DEHISCENCE  1  1/1119 (0.09%)  0/96 (0.00%) 
BONE CONTUSION  1  1/1119 (0.09%)  0/96 (0.00%) 
CARTILAGE INJURY  1  1/1119 (0.09%)  0/96 (0.00%) 
CERVICAL VERTEBRAL FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
CHEST INJURY  1  1/1119 (0.09%)  0/96 (0.00%) 
CONCUSSION  1  1/1119 (0.09%)  0/96 (0.00%) 
LACERATION  1  1/1119 (0.09%)  0/96 (0.00%) 
LIMB INJURY  1  1/1119 (0.09%)  0/96 (0.00%) 
LUMBAR VERTEBRAL FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
POST PROCEDURAL HAEMORRHAGE  1  1/1119 (0.09%)  0/96 (0.00%) 
RADIUS FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
RIB FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
ROAD TRAFFIC ACCIDENT  1  1/1119 (0.09%)  0/96 (0.00%) 
SPINAL COMPRESSION FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
TIBIA FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
UPPER LIMB FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
WOUND SECRETION  1  0/1119 (0.00%)  1/96 (1.04%) 
WRIST FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  1/1119 (0.09%)  0/96 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/1119 (0.09%)  0/96 (0.00%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  2/1119 (0.18%)  0/96 (0.00%) 
HEPATIC ENZYME INCREASED  1  5/1119 (0.45%)  0/96 (0.00%) 
TRANSAMINASES INCREASED  1  1/1119 (0.09%)  0/96 (0.00%) 
WEIGHT DECREASED  1  1/1119 (0.09%)  0/96 (0.00%) 
BLOOD BILIRUBIN INCREASED  1  1/1119 (0.09%)  0/96 (0.00%) 
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  1/1119 (0.09%)  0/96 (0.00%) 
BLOOD TEST ABNORMAL  1  1/1119 (0.09%)  0/96 (0.00%) 
EJECTION FRACTION DECREASED  1  0/1119 (0.00%)  1/96 (1.04%) 
LIVER FUNCTION TEST INCREASED  1  1/1119 (0.09%)  0/96 (0.00%) 
Metabolism and nutrition disorders     
CACHEXIA  1  2/1119 (0.18%)  0/96 (0.00%) 
DECREASED APPETITE  1  2/1119 (0.18%)  0/96 (0.00%) 
DEHYDRATION  1  4/1119 (0.36%)  1/96 (1.04%) 
HYPERKALAEMIA  1  1/1119 (0.09%)  1/96 (1.04%) 
HYPOGLYCAEMIA  1  2/1119 (0.18%)  0/96 (0.00%) 
HYPOKALAEMIA  1  3/1119 (0.27%)  0/96 (0.00%) 
HYPONATRAEMIA  1  3/1119 (0.27%)  0/96 (0.00%) 
HYPERCALCAEMIA  1  3/1119 (0.27%)  0/96 (0.00%) 
Musculoskeletal and connective tissue disorders     
MUSCULOSKELETAL DISORDER  1  1/1119 (0.09%)  0/96 (0.00%) 
PATHOLOGICAL FRACTURE  1  0/1119 (0.00%)  1/96 (1.04%) 
ARTHRALGIA  1  1/1119 (0.09%)  0/96 (0.00%) 
BACK PAIN  1  1/1119 (0.09%)  0/96 (0.00%) 
MUSCLE SPASMS  1  1/1119 (0.09%)  0/96 (0.00%) 
OSTEOPOROTIC FRACTURE  1  1/1119 (0.09%)  0/96 (0.00%) 
ROTATOR CUFF SYNDROME  1  0/1119 (0.00%)  1/96 (1.04%) 
SOFT TISSUE MASS  1  1/1119 (0.09%)  0/96 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BREAST CANCER RECURRENT  1  1/1119 (0.09%)  0/96 (0.00%) 
HEPATIC CANCER  1  1/1119 (0.09%)  0/96 (0.00%) 
INFECTED NEOPLASM  1  3/1119 (0.27%)  0/96 (0.00%) 
LIP SQUAMOUS CELL CARCINOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
LUNG NEOPLASM MALIGNANT  1  2/1119 (0.18%)  0/96 (0.00%) 
METASTASES TO CENTRAL NERVOUS SYSTEM  1  0/1119 (0.00%)  1/96 (1.04%) 
METASTATIC SQUAMOUS CELL CARCINOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
NON−SMALL CELL LUNG CANCER METASTATIC  1  1/1119 (0.09%)  0/96 (0.00%) 
RECTAL ADENOCARCINOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
SQUAMOUS CELL CARCINOMA  1  4/1119 (0.36%)  0/96 (0.00%) 
SQUAMOUS CELL CARCINOMA OF SKIN  1  10/1119 (0.89%)  1/96 (1.04%) 
ADENOCARCINOMA OF COLON  1  1/1119 (0.09%)  1/96 (1.04%) 
MALIGNANT NEOPLASM OF EYELID  1  2/1119 (0.18%)  0/96 (0.00%) 
METASTATIC MALIGNANT MELANOMA  1  2/1119 (0.18%)  0/96 (0.00%) 
BASAL CELL CARCINOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
BENIGN NEOPLASM OF ADRENAL GLAND  1  1/1119 (0.09%)  0/96 (0.00%) 
COLON CANCER  1  1/1119 (0.09%)  0/96 (0.00%) 
GASTRIC CANCER  1  1/1119 (0.09%)  0/96 (0.00%) 
INTESTINAL ADENOCARCINOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
INVASIVE LOBULAR BREAST CARCINOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
LUNG ADENOCARCINOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
MARGINAL ZONE LYMPHOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
METASTASES TO BONE  1  0/1119 (0.00%)  1/96 (1.04%) 
NASAL CAVITY CANCER  1  1/1119 (0.09%)  0/96 (0.00%) 
PAPILLARY RENAL CELL CARCINOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
PARATHYROID TUMOUR BENIGN  1  1/1119 (0.09%)  0/96 (0.00%) 
RECTAL CANCER  1  1/1119 (0.09%)  0/96 (0.00%) 
RECTAL CANCER STAGE III  1  1/1119 (0.09%)  0/96 (0.00%) 
SKIN NEOPLASM BLEEDING  1  1/1119 (0.09%)  0/96 (0.00%) 
SQUAMOUS CELL BREAST CARCINOMA  1  1/1119 (0.09%)  0/96 (0.00%) 
TUMOUR HAEMORRHAGE  1  1/1119 (0.09%)  0/96 (0.00%) 
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  3/1119 (0.27%)  0/96 (0.00%) 
DIZZINESS  1  1/1119 (0.09%)  1/96 (1.04%) 
DYSGEUSIA  1  1/1119 (0.09%)  0/96 (0.00%) 
EMBOLIC STROKE  1  1/1119 (0.09%)  0/96 (0.00%) 
HAEMORRHAGE INTRACRANIAL  1  1/1119 (0.09%)  0/96 (0.00%) 
ISCHAEMIC STROKE  1  2/1119 (0.18%)  1/96 (1.04%) 
NERVOUS SYSTEM DISORDER  1  1/1119 (0.09%)  0/96 (0.00%) 
SYNCOPE  1  6/1119 (0.54%)  0/96 (0.00%) 
SPINAL CORD COMPRESSION  1  2/1119 (0.18%)  0/96 (0.00%) 
BRAIN OEDEMA  1  1/1119 (0.09%)  0/96 (0.00%) 
CEREBROSPINAL FISTULA  1  1/1119 (0.09%)  0/96 (0.00%) 
CEREBROVASCULAR DISORDER  1  1/1119 (0.09%)  0/96 (0.00%) 
DEMENTIA  1  1/1119 (0.09%)  0/96 (0.00%) 
FACIAL PARALYSIS  1  0/1119 (0.00%)  1/96 (1.04%) 
FACIAL PARESIS  1  1/1119 (0.09%)  0/96 (0.00%) 
FOCAL DYSCOGNITIVE SEIZURES  1  1/1119 (0.09%)  0/96 (0.00%) 
GENERALISED TONIC-CLONIC SEIZURE  1  1/1119 (0.09%)  0/96 (0.00%) 
LETHARGY  1  1/1119 (0.09%)  0/96 (0.00%) 
LOSS OF CONSCIOUSNESS  1  1/1119 (0.09%)  0/96 (0.00%) 
PARAESTHESIA  1  0/1119 (0.00%)  1/96 (1.04%) 
PARTIAL SEIZURES  1  1/1119 (0.09%)  0/96 (0.00%) 
PRESYNCOPE  1  1/1119 (0.09%)  0/96 (0.00%) 
SEIZURE  1  1/1119 (0.09%)  0/96 (0.00%) 
TRANSIENT ISCHAEMIC ATTACK  1  1/1119 (0.09%)  0/96 (0.00%) 
TRIGEMINAL NEURALGIA  1  1/1119 (0.09%)  0/96 (0.00%) 
Product Issues     
DEVICE DISLOCATION  1  2/1119 (0.18%)  0/96 (0.00%) 
Psychiatric disorders     
DEPRESSION  1  1/1119 (0.09%)  0/96 (0.00%) 
DISORIENTATION  1  1/1119 (0.09%)  0/96 (0.00%) 
ANXIETY  1  0/1119 (0.00%)  1/96 (1.04%) 
SOMATIC SYMPTOM DISORDER  1  1/1119 (0.09%)  0/96 (0.00%) 
SUICIDE ATTEMPT  1  1/1119 (0.09%)  0/96 (0.00%) 
Renal and urinary disorders     
RENAL FAILURE  1  2/1119 (0.18%)  2/96 (2.08%) 
URETHRAL STENOSIS  1  1/1119 (0.09%)  0/96 (0.00%) 
URINARY RETENTION  1  0/1119 (0.00%)  1/96 (1.04%) 
CHRONIC KIDNEY DISEASE  1  3/1119 (0.27%)  0/96 (0.00%) 
ACUTE KIDNEY INJURY  1  2/1119 (0.18%)  0/96 (0.00%) 
ACUTE PRERENAL FAILURE  1  1/1119 (0.09%)  0/96 (0.00%) 
HAEMORRHAGE URINARY TRACT  1  1/1119 (0.09%)  0/96 (0.00%) 
Reproductive system and breast disorders     
BENIGN PROSTATIC HYPERPLASIA  1  1/1119 (0.09%)  0/96 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
ACUTE PULMONARY OEDEMA  1  1/1119 (0.09%)  0/96 (0.00%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  4/1119 (0.36%)  0/96 (0.00%) 
PNEUMONIA ASPIRATION  1  2/1119 (0.18%)  0/96 (0.00%) 
PNEUMONITIS  1  1/1119 (0.09%)  0/96 (0.00%) 
PULMONARY EMBOLISM  1  3/1119 (0.27%)  0/96 (0.00%) 
DYSPNOEA  1  2/1119 (0.18%)  0/96 (0.00%) 
EPISTAXIS  1  2/1119 (0.18%)  0/96 (0.00%) 
ASTHMATIC CRISIS  1  1/1119 (0.09%)  0/96 (0.00%) 
PULMONARY OEDEMA  1  1/1119 (0.09%)  0/96 (0.00%) 
SINUS POLYP  1  1/1119 (0.09%)  0/96 (0.00%) 
TACHYPNOEA  1  1/1119 (0.09%)  0/96 (0.00%) 
Skin and subcutaneous tissue disorders     
ANGIOEDEMA  1  0/1119 (0.00%)  1/96 (1.04%) 
DERMATITIS  1  1/1119 (0.09%)  0/96 (0.00%) 
RASH  1  1/1119 (0.09%)  0/96 (0.00%) 
SKIN ULCER  1  1/1119 (0.09%)  0/96 (0.00%) 
DECUBITUS ULCER  1  1/1119 (0.09%)  0/96 (0.00%) 
DERMAL CYST  1  1/1119 (0.09%)  0/96 (0.00%) 
LICHEN SCLEROSUS  1  1/1119 (0.09%)  0/96 (0.00%) 
Surgical and medical procedures     
EYELID OPERATION  1  1/1119 (0.09%)  0/96 (0.00%) 
Vascular disorders     
ARTERIAL HAEMORRHAGE  1  1/1119 (0.09%)  0/96 (0.00%) 
ARTERIAL OCCLUSIVE DISEASE  1  1/1119 (0.09%)  0/96 (0.00%) 
DEEP VEIN THROMBOSIS  1  3/1119 (0.27%)  0/96 (0.00%) 
HYPOTENSION  1  0/1119 (0.00%)  1/96 (1.04%) 
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE  1  1/1119 (0.09%)  0/96 (0.00%) 
ORTHOSTATIC HYPOTENSION  1  2/1119 (0.18%)  1/96 (1.04%) 
AORTIC ANEURYSM  1  0/1119 (0.00%)  1/96 (1.04%) 
CIRCULATORY COLLAPSE  1  1/1119 (0.09%)  0/96 (0.00%) 
HAEMORRHAGE  1  0/1119 (0.00%)  1/96 (1.04%) 
HYPERTENSION  1  0/1119 (0.00%)  1/96 (1.04%) 
PERIPHERAL ISCHAEMIA  1  1/1119 (0.09%)  0/96 (0.00%) 
SHOCK HAEMORRHAGIC  1  1/1119 (0.09%)  0/96 (0.00%) 
THROMBOSIS  1  1/1119 (0.09%)  0/96 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vismodegib - Locally Advanced Vismodegib - Metastatic
Affected / at Risk (%) Affected / at Risk (%)
Total   1065/1119 (95.17%)   90/96 (93.75%) 
Blood and lymphatic system disorders     
ANAEMIA  1  81/1119 (7.24%)  14/96 (14.58%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  78/1119 (6.97%)  8/96 (8.33%) 
ABDOMINAL PAIN UPPER  1  64/1119 (5.72%)  6/96 (6.25%) 
CONSTIPATION  1  107/1119 (9.56%)  14/96 (14.58%) 
DIARRHOEA  1  183/1119 (16.35%)  18/96 (18.75%) 
NAUSEA  1  197/1119 (17.61%)  24/96 (25.00%) 
VOMITING  1  96/1119 (8.58%)  6/96 (6.25%) 
General disorders     
ASTHENIA  1  276/1119 (24.66%)  19/96 (19.79%) 
FATIGUE  1  185/1119 (16.53%)  16/96 (16.67%) 
OEDEMA PERIPHERAL  1  34/1119 (3.04%)  5/96 (5.21%) 
Infections and infestations     
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  55/1119 (4.92%)  6/96 (6.25%) 
Investigations     
WEIGHT DECREASED  1  471/1119 (42.09%)  38/96 (39.58%) 
ALANINE AMINOTRANSFERASE INCREASED  1  54/1119 (4.83%)  6/96 (6.25%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  52/1119 (4.65%)  7/96 (7.29%) 
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  59/1119 (5.27%)  10/96 (10.42%) 
GAMMA−GLUTAMYLTRANSFERASE INCREASED  1  55/1119 (4.92%)  5/96 (5.21%) 
BLOOD CREATININE INCREASED  1  31/1119 (2.77%)  6/96 (6.25%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  283/1119 (25.29%)  23/96 (23.96%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  117/1119 (10.46%)  9/96 (9.38%) 
BACK PAIN  1  53/1119 (4.74%)  7/96 (7.29%) 
MUSCLE SPASMS  1  754/1119 (67.38%)  62/96 (64.58%) 
MUSCULOSKELETAL PAIN  1  31/1119 (2.77%)  8/96 (8.33%) 
PAIN IN EXTREMITY  1  49/1119 (4.38%)  9/96 (9.38%) 
MYALGIA  1  78/1119 (6.97%)  7/96 (7.29%) 
Nervous system disorders     
AGEUSIA  1  201/1119 (17.96%)  12/96 (12.50%) 
DIZZINESS  1  66/1119 (5.90%)  9/96 (9.38%) 
DYSGEUSIA  1  620/1119 (55.41%)  47/96 (48.96%) 
HEADACHE  1  87/1119 (7.77%)  9/96 (9.38%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  64/1119 (5.72%)  12/96 (12.50%) 
DYSPNOEA  1  26/1119 (2.32%)  12/96 (12.50%) 
Skin and subcutaneous tissue disorders     
ALOPECIA  1  700/1119 (62.56%)  50/96 (52.08%) 
PRURITUS  1  61/1119 (5.45%)  9/96 (9.38%) 
ACTINIC KERATOSIS  1  46/1119 (4.11%)  5/96 (5.21%) 
Vascular disorders     
HYPERTENSION  1  58/1119 (5.18%)  6/96 (6.25%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01367665     History of Changes
Other Study ID Numbers: MO25616
2011-000195-34 ( EudraCT Number )
First Submitted: May 30, 2011
First Posted: June 7, 2011
Results First Submitted: June 13, 2018
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019