Efficacy and Safety of BEZ235 Compared to Everolimus in P... | NCT01628913

ID	Type	Description	Link
CBEZ235Z2401	Other Identifier	Novartis
2012-000769-19

Status Module

Label	Type	Description	Intervention Names
BEZ235	Experimental	Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)	Drug: BEZ235
Everolimus	Active Comparator	Patients received Everolimus 10 mg qd p.o. (by mouth, daily)	Drug: Everolimus

Name	Type	Description	Arm Group Labels	Other Names
BEZ235	Drug	BEZ235 400 mg bid p.o. (by mouth, twice daily)	BEZ235

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 12 weeks after randomization. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of all target lesions, or unequivocal progression of non-target lesions, or the appearance of new lesions.	up to approx. 18 months

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate	Proportion of patients with a best overall response during the study of complete response (CR) or partial response (PR), based on the investigator assessment. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for all target and non-target lesions, as well as new lesions as assessed by CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of all target lesions; Overall Response (OR) = CR + PR.

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cedars Sinai Medical Center SC-3		Los Angeles	California	90048	United States
University of Colorado Univ Colorado

PubMed Identifier	Type	Citation	Retractions
29242283	Derived	Salazar R, Garcia-Carbonero R, Libutti SK, Hendifar AE, Custodio A, Guimbaud R, Lombard-Bohas C, Ricci S, Klumpen HJ, Capdevila J, Reed N, Walenkamp A, Grande E, Safina S, Meyer T, Kong O, Salomon H, Tavorath R, Yao JC. Phase II Study of BEZ235 versus Everolimus in Patients with Mammalian Target of Rapamycin Inhibitor-Naive Advanced Pancreatic Neuroendocrine Tumors. Oncologist. 2018 Jul;23(7):766-e90. doi: 10.1634/theoncologist.2017-0144. Epub 2017 Dec 14.

Results Section

Participant Flow Module

ID	Title	Description
FG000	BEZ235	Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
FG001	Everolimus	Patients received Everolimus 10 mg qd p.o. (by mouth, daily)

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

Progression Free Survival (PFS)

PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 12 weeks after randomization. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of all target lesions, or unequivocal progression of non-target lesions, or the appearance of new lesions.

Full analysis set: The Full analysis set (FAS) comprised all patients who were randomized to study treatment. According to the intent to treat principle, patient was analyzed according to the treatment and strata they had been assigned to during the randomization procedure.

Posted

Median

95% Confidence Interval

Months

up to approx. 18 months

ID	Title	Description
OG000	BEZ235	Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
OG001	Everolimus	Patients received Everolimus 10 mg qd p.o. (by mouth, daily)

Units	Counts
Participants	OG00031 OG00131

Title

Denominators

Categories

Title	Measurements
	OG0008.2(5.3 to NA)Upper Limit could not be calculated due to insufficient number of events. OG00110.8(8.1 to NA)Upper Limit could not be calculated due to insufficient number of events.

Secondary

Objective Response Rate

Proportion of patients with a best overall response during the study of complete response (CR) or partial response (PR), based on the investigator assessment. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for all target and non-target lesions, as well as new lesions as assessed by CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of all target lesions; Overall Response (OR) = CR + PR.

Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.

Posted

up to approx. 18 months

ID	Title	Description
OG000	BEZ235	Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
OG001	Everolimus	Patients received Everolimus 10 mg qd p.o. (by mouth, daily)

Units	Counts
Participants

Secondary

Overall Survival (OS)

Time from randomization to the date of death due to any cause

Posted

up to approx. 30 months

ID	Title	Description
OG000	BEZ235	Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
OG001	Everolimus	Patients received Everolimus 10 mg qd p.o. (by mouth, daily)

Units	Counts
Participants	OG000

Secondary

Time to Treatment Failure (TTF)

Time from randomization to the date of the first of the following events:death due to any cause or progressive disease, treatment discontinuation due to toxicity or treatment discontinuation due to patient preference

Posted

up to approx. 18 months

ID	Title	Description
OG000	BEZ235	Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
OG001	Everolimus	Patients received Everolimus 10 mg qd p.o. (by mouth, daily)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Cushing's syndrome	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0010 affected31 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Escherichia sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Febrile infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
B-cell lymphoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Nephritis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0011 affected31 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0011 affected31 at risk
Embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0010 affected31 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0008 affected31 at risk EG00111 affected31 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0012 affected31 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0014 affected31 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0011 affected31 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0013 affected31 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected31 at risk EG0018 affected31 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected31 at risk EG0015 affected31 at risk
Cheilitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected31 at risk EG0015 affected31 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00028 affected31 at risk EG00117 affected31 at risk
Dry mouth	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0014 affected31 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Flatulence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected31 at risk EG0012 affected31 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00017 affected31 at risk EG00110 affected31 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Proctalgia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Proctitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00023 affected31 at risk EG00120 affected31 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00014 affected31 at risk EG0017 affected31 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG00013 affected31 at risk EG00113 affected31 at risk
Face oedema	General disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0007 affected31 at risk EG00110 affected31 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0012 affected31 at risk
Mucosal inflammation	General disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0013 affected31 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0006 affected31 at risk EG00111 affected31 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0009 affected31 at risk EG0014 affected31 at risk
Xerosis	General disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0013 affected31 at risk
Conjunctivitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0012 affected31 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0015 affected31 at risk
Oral herpes	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Tooth infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0014 affected31 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0013 affected31 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0010 affected31 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0005 affected31 at risk EG0013 affected31 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0004 affected31 at risk EG0012 affected31 at risk
Blood cholesterol increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0014 affected31 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0006 affected31 at risk EG0012 affected31 at risk
Cardiac murmur	Investigations	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0010 affected31 at risk
Pancreatic enzymes decreased	Investigations	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Platelet count decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0017 affected31 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0004 affected31 at risk EG0016 affected31 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0009 affected31 at risk EG00113 affected31 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0014 affected31 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0009 affected31 at risk EG00111 affected31 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0015 affected31 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0012 affected31 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0011 affected31 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0012 affected31 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0014 affected31 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected31 at risk EG0012 affected31 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0011 affected31 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0011 affected31 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0013 affected31 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0012 affected31 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Dysgeusia	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected31 at risk EG0013 affected31 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected31 at risk EG0017 affected31 at risk
Lethargy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0011 affected31 at risk
Tremor	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0011 affected31 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0012 affected31 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0013 affected31 at risk
Proteinuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0011 affected31 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected31 at risk EG0018 affected31 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0015 affected31 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected31 at risk EG0015 affected31 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0014 affected31 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0012 affected31 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0011 affected31 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0018 affected31 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0014 affected31 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0006 affected31 at risk EG0012 affected31 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00011 affected31 at risk EG00113 affected31 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected31 at risk EG0012 affected31 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0010 affected31 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected31 at risk EG0012 affected31 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected31 at risk EG0012 affected31 at risk

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018302	Neoplasms, Neuroepithelial
D009375	Neoplasms, Glandular and Epithelial

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

ID	Title	Description
BG000	BEZ235	Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
BG001	Everolimus	Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
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	BEZ235	Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)			11	31	31	31
EG001	Everolimus	Patients received Everolimus 10 mg qd p.o. (by mouth, daily)			9	31	30	31

ID	Term
D018358	Neuroendocrine Tumors
D018242	Neuroectodermal Tumors, Primitive