STEVIE: A Study of Vismodegib in Patients With Locally Ad... | NCT01367665

ID	Type	Description	Link
2011-000195-34	EudraCT Number

Label	Type	Description	Intervention Names
Vismodegib - Locally Advanced	Experimental	Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity	Drug: vismodegib
Vismodegib - Metastatic	Experimental	Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity	Drug: vismodegib

Name	Type	Description	Arm Group Labels	Other Names
vismodegib	Drug	150 mg once daily until disease progression or unacceptable toxicity	Vismodegib - Locally Advanced Vismodegib - Metastatic

Measure	Description	Time Frame
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)	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.	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons	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)."	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters		Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Exposure to Study Treatment: Duration on Treatment	Duration on treatment was the number of days between first and last dose of study treatment.	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Exposure to Study Treatment - Dose Intensity	Dose intensity was defined as the percentage of actual number of doses received versus planned.

Measure	Description	Time Frame
Best Overall Response Rate (BORR)	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.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia		Buenos Aires		1417	Argentina
Premier Specialists

PubMed Identifier	Type	Citation	Retractions
32374193	Derived	Bossi P, Peris K, Calzavara-Pinton P, Queirolo P, Alfieri S, Palla M, Rossi MT, Spagnolo F, Tambone S, Astolfi C, Ascierto PA. Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study. Future Oncol. 2020 Jun;16(16):1091-1100. doi: 10.2217/fon-2019-0664. Epub 2020 May 6.
29073584

ID	Title	Description
FG000	Vismodegib - Locally Advanced	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.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 4, 2016	Jun 13, 2018

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

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)

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.

Posted

Number

percentage of participants

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Units	Counts
Participants	OG0001119 OG00196

Title

Denominators

Categories

Any AEs

Title	Measurements
	OG00098.4 OG00199.0

Any AEs with maximum severity of Grade 3 or 4

Title	Measurements
	OG000

Primary

Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons

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)."

Posted

Number

percentage of participants

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Units	Counts
Participants

Primary

Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters

Posted

Number

percentage of participants

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Units	Counts
Participants	OG000

Primary

Exposure to Study Treatment: Duration on Treatment

Duration on treatment was the number of days between first and last dose of study treatment.

Posted

Median

Full Range

days

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Units	Counts
Participants	OG000

Primary

Exposure to Study Treatment - Dose Intensity

Dose intensity was defined as the percentage of actual number of doses received versus planned.

Posted

Median

Full Range

percentage of doses

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Units	Counts
Participants	OG000

Secondary

Best Overall Response Rate (BORR)

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.

Only included participants that had histologically confirmed measurable disease at baseline.

Posted

Number

percentage of participants

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Secondary

Duration of Response

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.

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.

Posted

Median

95% Confidence Interval

months

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Secondary

Time to Response

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).

Only included participants that had histologically confirmed measurable disease at baseline.

Posted

Median

95% Confidence Interval

months

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Units	Counts
Participants

Secondary

Progression-Free Survival (PFS)

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.

Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable).

Posted

Median

95% Confidence Interval

months

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Units	Counts

Secondary

Overall Survival (OS)

OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.

Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable).

Posted

Median

95% Confidence Interval

months

Baseline to the data cut-off of 14 June 2017 (up to 6 years)

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Units	Counts
Participants

Secondary

Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom

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).

Only included participants that had histologically confirmed disease at baseline. For each time point, Number Analyzed refers to patients with non-missing values.

Posted

Mean

Standard Deviation

units on a scale

Baseline to the data cut-off date of 14 June 2017 (up to 6 years).

ID	Title	Description
OG000	Vismodegib - Locally Advanced	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.
OG001	Vismodegib - Metastatic	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.

Secondary

Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale

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.

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.

Posted

Number

Percentage of participants

08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).

ID	Title	Description
OG000	Vismodegib - Metastatic	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.

Secondary

Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale

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.

Posted

Number

Percentage of participants

08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).

ID	Title	Description
OG000	Vismodegib - Metastatic	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0004 affected1,119 at risk EG0011 affected96 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LEFT VENTRICULAR DILATION	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0008 affected1,119 at risk EG0011 affected96 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SINUS NODE DYSFUNCTION	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
VOLVULUS	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
PHARYNGO-OESOPHAGEAL DIVERTICULUM	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ASTHENIA	General disorders	MedDRA (20.0)	Systematic Assessment	EG0004 affected1,119 at risk EG0010 affected96 at risk
CHEST PAIN	General disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA (20.0)	Systematic Assessment	EG00011 affected1,119 at risk EG0011 affected96 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SUDDEN DEATH	General disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0011 affected96 at risk
TERMINAL STATE	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0011 affected96 at risk
CHOLESTASIS	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HEPATITIS	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HEPATOTOXICITY	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
ABSCESS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
APPENDICITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BRAIN ABSCESS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CELLULITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
CLOSTRIDIUM COLITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0011 affected96 at risk
CYSTITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
DIVERTICULITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
ENDOCARDITIS BACTERIAL	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ENTEROCOCCAL SEPSIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0005 affected1,119 at risk EG0011 affected96 at risk
GASTROENTERITIS CLOSTRIDIAL	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
GROIN ABSCESS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
HERPES ZOSTER	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
INFECTED SKIN ULCER	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
PNEUMONIA	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG00017 affected1,119 at risk EG0011 affected96 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SEPSIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
SOFT TISSUE INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
EYEBALL AVULSION	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
FALL	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0008 affected1,119 at risk EG0010 affected96 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
FOREIGN BODY	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0006 affected1,119 at risk EG0010 affected96 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PROCEDURAL INTESTINAL PERFORATION	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0005 affected1,119 at risk EG0010 affected96 at risk
TRANSAMINASES INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
WEIGHT DECREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CACHEXIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0004 affected1,119 at risk EG0011 affected96 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0011 affected96 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
MUSCULOSKELETAL DISORDER	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
BREAST CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HEPATIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
INFECTED NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
LIP SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
METASTATIC SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
NON-SMALL CELL LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
RECTAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0004 affected1,119 at risk EG0010 affected96 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG00010 affected1,119 at risk EG0011 affected96 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
DIZZINESS	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0011 affected96 at risk
DYSGEUSIA	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
EMBOLIC STROKE	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0011 affected96 at risk
NERVOUS SYSTEM DISORDER	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SYNCOPE	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected1,119 at risk EG0010 affected96 at risk
DEPRESSION	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DISORIENTATION	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0012 affected96 at risk
URETHRAL STENOSIS	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0004 affected1,119 at risk EG0010 affected96 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ARTERIAL HAEMORRHAGE	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
HYPOTENSION	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BRONCHITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0005 affected1,119 at risk EG0010 affected96 at risk
NORMOCHROMATIC NORMOCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
THROMBOCYTOMPENIA	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
ACUTE LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0011 affected96 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CONGESTIVE CARDIOMYOPATHY	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
VOMITING	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
ABDOMINAL INCARCERATED HERNIA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
GASTRIC PERFORATION	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
ILEUS	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ILL-DEFINED DISORDER	General disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
PYREXIA	General disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
CYST	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DEATH	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
GAIT DISTURBANCE	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HERNIA	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
IMPAIRED HEALING	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PAIN	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
PERFORMANCE STATUS DECREASED	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0004 affected1,119 at risk EG0010 affected96 at risk
BILE DUCT OBSTRUCTION	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BILIARY CYST	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CHOLANGITIS ACUTE	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DRUG-INDUCED LIVER INJURY	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HEPATIC MASS	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HEPATITIS TOXIC	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HEPATOCELLULAR INJURY	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0004 affected1,119 at risk EG0010 affected96 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0011 affected96 at risk
LUNG INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
UROSEPSIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
ABSCESS LIMB	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ACTINOMYCOSIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ACUTE SINUSITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ENDOPHTHALMITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ERYSIPELAS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
GANGRENE	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
MENINGITIS BACTERIAL	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
MORGANELLA INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ORBITAL INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PERIORBITAL CELLULITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
ABDOMINAL WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BONE CONTUSION	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CARTILAGE INJURY	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CERVICAL VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CHEST INJURY	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
WOUND SECRETION	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BLOOD TEST ABNORMAL	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
EJECTION FRACTION DECREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
LIVER FUNCTION TEST INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
OSTEOPOROTIC FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
SOFT TISSUE MASS	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0011 affected96 at risk
MALIGNANT NEOPLASM OF EYELID	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
METASTATIC MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
BENIGN NEOPLASM OF ADRENAL GLAND	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
INTESTINAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
INVASIVE LOBULAR BREAST CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
MARGINAL ZONE LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
NASAL CAVITY CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PAPILLARY RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PARATHYROID TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
RECTAL CANCER STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SKIN NEOPLASM BLEEDING	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SQUAMOUS CELL BREAST CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
TUMOUR HAEMORRHAGE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
BRAIN OEDEMA	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CEREBROSPINAL FISTULA	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CEREBROVASCULAR DISORDER	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DEMENTIA	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
FACIAL PARALYSIS	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
FACIAL PARESIS	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
FOCAL DYSCOGNITIVE SEIZURES	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
GENERALISED TONIC-CLONIC SEIZURE	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LETHARGY	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PARAESTHESIA	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
PARTIAL SEIZURES	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PRESYNCOPE	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SEIZURE	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
TRIGEMINAL NEURALGIA	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ANXIETY	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
SOMATIC SYMPTOM DISORDER	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,119 at risk EG0010 affected96 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
ACUTE PRERENAL FAILURE	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HAEMORRHAGE URINARY TRACT	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
ASTHMATIC CRISIS	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SINUS POLYP	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
TACHYPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DERMAL CYST	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LICHEN SCLEROSUS	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0011 affected96 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
HAEMORRHAGE	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
HYPERTENSION	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,119 at risk EG0011 affected96 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
SHOCK HAEMORRHAGIC	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
THROMBOSIS	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
VERTIGO POSITIONAL	Ear and labyrinth disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DIPLOPIA	Eye disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
LAGOPHTHALMOS	Eye disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
RETINAL ARTERY OCCLUSION	Eye disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
DEVICE DISLOCATION	Product Issues	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,119 at risk EG0010 affected96 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 at risk
EYELID OPERATION	Surgical and medical procedures	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,119 at risk EG0010 affected96 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 - Locally Advanced	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.
BG001	Vismodegib - Metastatic	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.
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 - Locally Advanced	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.	103	1,119	272	1,119	1,065	1,119
EG001	Vismodegib - Metastatic	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.	19	96	31	96	90	96