Safety and Efficacy Clinical Study of SNS-595 in Patients... | NCT00408603

Label	Type	Description	Intervention Names
All study patients	Experimental	All patients will receive voreloxin injection	Drug: Voreloxin Injection

Name	Type	Description	Arm Group Labels	Other Names
Voreloxin Injection	Drug	All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.

Measure	Description	Time Frame
Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria	Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.	GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period

Measure	Description	Time Frame
Progression-free Survival (PFS) Using Kaplan-Meier Methods	PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression. For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules. For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules. For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment.

Name	Affiliation	Role
Sunesis Medical Monitor, MD	Sunesis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Premiere Oncology of Arizona		Scottsdale	Arizona	85260	United States
Gynecologic Oncology Associates

ID	Title	Description
FG000	Stage 48 mg/m2	All Stage 1 patients will receive voreloxin injection Voreloxin Injection: All Stage 1 patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles.
FG001	Stage 60 mg/m2

ID	Title	Description
BG000	48 mg/m2	48 mg/m2 every 21 days
BG001	60 mg/m2	60 mg/m2 every 28 days
BG002	75 mg/m2	75 mg/m2 every 28 days
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00065 BG00137 BG00235 BG003137

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00014 affected65 at risk EG00114 affected37 at risk EG00213 affected35 at risk EG00341 affected137 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0013 affected37 at risk EG0021 affected35 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected65 at risk EG0012 affected37 at risk EG0022 affected35 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected65 at risk EG0018 affected37 at risk EG00218 affected35 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0024 affected35 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Palpitations	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0012 affected37 at risk EG0022 affected35 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Blepharospasm	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Dark circles under eyes	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Dry eye	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0022 affected35 at risk EG003
Lacrimation increased	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Photophobia	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Photopsia	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Vision blurred	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0011 affected37 at risk EG0022 affected35 at risk EG003
Visual disturbance	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00016 affected65 at risk EG0019 affected37 at risk EG0029 affected35 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Abdominal mass	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00022 affected65 at risk EG0017 affected37 at risk EG00212 affected35 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0012 affected37 at risk EG0024 affected35 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected65 at risk EG0012 affected37 at risk EG0021 affected35 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0010 affected37 at risk EG0023 affected35 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Anal inflammation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected65 at risk EG0011 affected37 at risk EG0023 affected35 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Colonic stenosis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00025 affected65 at risk EG00123 affected37 at risk EG00211 affected35 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00026 affected65 at risk EG00112 affected37 at risk EG00217 affected35 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0013 affected37 at risk EG0023 affected35 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00019 affected65 at risk EG0014 affected37 at risk EG0025 affected35 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Gastric hypomotility	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected65 at risk EG0016 affected37 at risk EG0021 affected35 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0013 affected37 at risk EG0021 affected35 at risk EG003
Lip pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Lip ulceration	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0022 affected35 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00051 affected65 at risk EG00127 affected37 at risk EG00224 affected35 at risk EG003
Obstruction gastric	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Oral discomfort	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Peritonitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Retching	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Salivary gland disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Sensitivity of teeth	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0013 affected37 at risk EG0021 affected35 at risk EG003
Stomach discomfort	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00019 affected65 at risk EG0018 affected37 at risk EG0023 affected35 at risk EG003
Tongue disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Tongue oedema	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Tongue ulceration	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00026 affected65 at risk EG00119 affected37 at risk EG00217 affected35 at risk EG003
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0011 affected37 at risk EG0022 affected35 at risk EG003
Chest discomfort	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected65 at risk EG0011 affected37 at risk EG0024 affected35 at risk EG003
Early satiety	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0012 affected37 at risk EG0021 affected35 at risk EG003
Face oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG00052 affected65 at risk EG00130 affected37 at risk EG00227 affected35 at risk EG003
Gait disturbance	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Hernia pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Influenza like illness	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Infusion site bruising	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Infusion site erythema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Infusion site rash	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Infusion site reaction	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Injection site erythema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Injection site reaction	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0022 affected35 at risk EG003
Irritability	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Local swelling	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Nodule	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0012 affected37 at risk EG0021 affected35 at risk EG003
Oedema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected65 at risk EG0016 affected37 at risk EG0022 affected35 at risk EG003
Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0012 affected37 at risk EG0026 affected35 at risk EG003
Peripheral coldness	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected65 at risk EG0013 affected37 at risk EG0028 affected35 at risk EG003
Temperature intolerance	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0023 affected35 at risk EG003
Visceral oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0022 affected35 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Bacterial infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Clostridial infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Cystitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Folliculitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Fungal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Genital herpes	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Gingival infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Lung infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0005 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Neutropenic infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0022 affected35 at risk EG003
Oral herpes	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Perianal abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Rhinitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Tooth infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0013 affected37 at risk EG0020 affected35 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0004 affected65 at risk EG0015 affected37 at risk EG00210 affected35 at risk EG003
Urosepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Vaginal candidiasis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Incision site erythema	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Blood creatinine increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Blood potassium decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Breath sounds abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0012 affected37 at risk EG0021 affected35 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
International normalised ratio increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Lymph node palpable	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Red blood cell count decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Weight decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0006 affected65 at risk EG0016 affected37 at risk EG0023 affected35 at risk EG003
White blood cell count decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
White blood cell count increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00027 affected65 at risk EG00115 affected37 at risk EG00212 affected35 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected65 at risk EG0012 affected37 at risk EG0026 affected35 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected65 at risk EG0017 affected37 at risk EG0026 affected35 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0015 affected37 at risk EG0023 affected35 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected65 at risk EG0016 affected37 at risk EG0023 affected35 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected65 at risk EG0018 affected37 at risk EG0027 affected35 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Jaw disorder	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0022 affected35 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0012 affected37 at risk EG0024 affected35 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0011 affected37 at risk EG0022 affected35 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected65 at risk EG0014 affected37 at risk EG0022 affected35 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Spinal haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Amnesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Balance disorder	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected65 at risk EG0012 affected37 at risk EG0025 affected35 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00017 affected65 at risk EG0014 affected37 at risk EG0026 affected35 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected65 at risk EG0015 affected37 at risk EG0024 affected35 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0022 affected35 at risk EG003
Memory impairment	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Migraine	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Migraine with aura	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Neuropathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0011 affected37 at risk EG0022 affected35 at risk EG003
Pallanaesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0022 affected35 at risk EG003
Parosmia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0022 affected35 at risk EG003
Somnolence	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Syncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Tremor	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Agitation	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0011 affected37 at risk EG0023 affected35 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0022 affected35 at risk EG003
Depression	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected65 at risk EG0011 affected37 at risk EG0023 affected35 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0018 affected37 at risk EG0022 affected35 at risk EG003
Bladder discomfort	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Bladder pain	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Bladder spasm	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0012 affected37 at risk EG0022 affected35 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0022 affected35 at risk EG003
Incontinence	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0022 affected35 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0013 affected37 at risk EG0023 affected35 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Genital pain	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Vaginal pain	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Vulvovaginal discomfort	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected65 at risk EG0018 affected37 at risk EG0027 affected35 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00020 affected65 at risk EG0016 affected37 at risk EG0027 affected35 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0022 affected35 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0012 affected37 at risk EG0021 affected35 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected65 at risk EG0017 affected37 at risk EG0029 affected35 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0012 affected37 at risk EG0021 affected35 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Postnasal drip	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00040 affected65 at risk EG00124 affected37 at risk EG00226 affected35 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Hair colour changes	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0012 affected37 at risk EG0022 affected35 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0022 affected35 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0010 affected37 at risk EG0023 affected35 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0012 affected37 at risk EG0020 affected35 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0013 affected37 at risk EG0022 affected35 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected65 at risk EG0014 affected37 at risk EG0022 affected35 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0021 affected35 at risk EG003
Skin nodule	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Skin odour abnormal	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003
Flushing	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected65 at risk EG0012 affected37 at risk EG0023 affected35 at risk EG003
Hot flush	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected65 at risk EG0011 affected37 at risk EG0025 affected35 at risk EG003
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0011 affected37 at risk EG0022 affected35 at risk EG003
Lymphoedema	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0011 affected37 at risk EG0020 affected35 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected65 at risk EG0010 affected37 at risk EG0021 affected35 at risk EG003
Phlebitis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected65 at risk EG0010 affected37 at risk EG0020 affected35 at risk EG003

ID	Term
D000077216	Carcinoma, Ovarian Epithelial
D009369	Neoplasms
D002277	Carcinoma

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D010051	Ovarian Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	48 mg/m2	48 mg/m2 every 21 days	7	65	15	65	63	65
EG001	60 mg/m2	60 mg/m2 every 28 days	2	37	9	37	37	37
EG002	75 mg/m2	75 mg/m2 every 28 days	3	35	14	35	35	35
EG003	Total	Overall	11	137	38	137	135	137