A Study of Two Vismodegib Regimens in Participants With M... | NCT01815840

ID	Type	Description	Link
2012-003305-10	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vismodegib Intermittent Schedule	Experimental	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Drug: Vismodegib Drug: Placebo
Vismodegib Induction Followed by Intermittent Schedule	Experimental	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Drug: Vismodegib Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vismodegib	Drug	Vismodegib 150 mg hard gelatin capsule orally once daily	Vismodegib Induction Followed by Intermittent Schedule Vismodegib Intermittent Schedule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)	The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.	Baseline; Week 73

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues	The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.	Baseline to Week 73
Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology Research Associate		Los Angeles	California	90045	United States
Stanford University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28325399	Derived	Jacobsen AA, Kydd AR, Strasswimmer J. Practical management of the adverse effects of Hedgehog pathway inhibitor therapy for basal cell carcinoma. J Am Acad Dermatol. 2017 Apr;76(4):767-768. doi: 10.1016/j.jaad.2016.04.063. No abstract available.
28188086	Derived	Dreno B, Kunstfeld R, Hauschild A, Fosko S, Zloty D, Labeille B, Grob JJ, Puig S, Gilberg F, Bergstrom D, Page DR, Rogers G, Schadendorf D. Two intermittent vismodegib dosing regimens in patients with multiple basal-cell carcinomas (MIKIE): a randomised, regimen-controlled, double-blind, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):404-412. doi: 10.1016/S1470-2045(17)30072-4. Epub 2017 Feb 8.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
FG001	Vismodegib Induction Followed by Intermittent Schedule

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)

The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.

Participants in the Intent-to-Treat analysis population (defined as all randomized participants) with available data were included in the analysis. The last observation carried forward method was used.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 73

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants	OG000114 OG001113

Title

Denominators

Categories

Title	Measurements
	OG00062.9± 52.01 OG00154.9± 54.85

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The mean difference in the mean relative reduction between treatment arms, along with the corresponding 95% confidence interval, was estimated by fitting an ANCOVA model with treatment as main effect and the following covariates: number of basal cell carcinomas at baseline, geographical region, immunosuppression status, confirmed basal cell carcinoma nevus syndrome.					Mean Difference (Final Values)	-8.3			2-Sided	95	-22.2	5.7			Asymptotic confidence intervals are presented for the difference between treatment arms.		Superiority or Other

Secondary

Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues

The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.

Intent-to-Treat Analysis Population, defined as all randomized participants.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Week 73

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants

Secondary

Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73

The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.

Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 73

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants

Secondary

Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73

Intent-to-Treat Analysis Population, defined as all randomized participants.

Posted

Number

percentage of participants

Baseline; Week 73

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With New Basal Cell Carcinomas at Week 73

Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Posted

Number

percentage of participants

Baseline; Week 73

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants	OG000

Secondary

Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate)

Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 85

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants	OG000

Secondary

Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)

Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 97

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants	OG000

Secondary

Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)

Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 125

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Experiencing Any Adverse Event

Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.

Posted

Number

percentage of participants

Up to 125 weeks

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73

The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").

Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 73

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants

Secondary

Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73

The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their emotional state, and their answers were combined into a composite Emotion Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").

Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 73

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants

Secondary

Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73

The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their ability to function, and answers were combined into a composite Function Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").

Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 73

ID	Title	Description
OG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
OG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0003 affected114 at risk EG0010 affected113 at risk
Abscess limb	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Cellulitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Diverticulitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Kidney infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Pyelonephritis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0012 affected113 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Spindle cell sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Myocardial infarction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0011 affected113 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Angina pectoris	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Bradycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Lethargy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Nervous system disorder	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Tremor	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0011 affected113 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Pseudolymphoma	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Hepatic enzyme increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
International normalized ratio increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Platelet count decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Depression	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Personality change	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Congenital cerebral cyst	Congenital, familial and genetic disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Asthenia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0011 affected113 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Primary amyloidosis	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Xanthelasma	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0011 affected113 at risk
Haematoma	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected114 at risk EG0011 affected113 at risk
Seminoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0010 affected113 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00083 affected114 at risk EG00194 affected113 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00018 affected114 at risk EG00116 affected113 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00018 affected114 at risk EG00112 affected113 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0007 affected114 at risk EG0017 affected113 at risk
Dysgeusia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG00076 affected114 at risk EG00175 affected113 at risk
Ageusia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG00013 affected114 at risk EG00114 affected113 at risk
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG00010 affected114 at risk EG00114 affected113 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00072 affected114 at risk EG00173 affected113 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0008 affected114 at risk EG00113 affected113 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00010 affected114 at risk EG0018 affected113 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG00020 affected114 at risk EG00120 affected113 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG00023 affected114 at risk EG00114 affected113 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0008 affected114 at risk EG00112 affected113 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0009 affected114 at risk EG0018 affected113 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0009 affected114 at risk EG0015 affected113 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0007 affected114 at risk EG0014 affected113 at risk
Fatigue	General disorders	MedDRA (18.0)	Systematic Assessment	EG00024 affected114 at risk EG00126 affected113 at risk
Asthenia	General disorders	MedDRA (18.0)	Systematic Assessment	EG00015 affected114 at risk EG00121 affected113 at risk
Weight decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG00024 affected114 at risk EG00121 affected113 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG00011 affected114 at risk EG00115 affected113 at risk
Alanine aminotransferase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0007 affected114 at risk EG0015 affected113 at risk
Nasopharyngitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0007 affected114 at risk EG00112 affected113 at risk
Folliculitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00010 affected114 at risk EG0018 affected113 at risk
Bronchitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0005 affected114 at risk EG0018 affected113 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0007 affected114 at risk EG0015 affected113 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG00021 affected114 at risk EG00117 affected113 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0006 affected114 at risk EG0010 affected113 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected114 at risk EG0017 affected113 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0006 affected114 at risk EG0012 affected113 at risk
Insomnia	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected114 at risk EG0016 affected113 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0006 affected114 at risk EG0015 affected113 at risk
Hypertension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected114 at risk EG0016 affected113 at risk
Pyrexia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected114 at risk EG0018 affected113 at risk

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018295	Neoplasms, Basal Cell

ID	Title	Description
BG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
BG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vismodegib Intermittent Schedule	Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up			24	114	107	114
EG001	Vismodegib Induction Followed by Intermittent Schedule	Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up			23	113	108	113