Phase I/II Study of KRN330 Plus Irinotecan in Patients Wi... | NCT00838578

Name	Class
Kyowa Hakko Kirin Pharma, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
KRN330 + Irinotecan	Experimental	open label, single arm	Biological: KRN330 Drug: Irinotecan

Name	Type	Description	Arm Group Labels	Other Names
KRN330	Biological	KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.	KRN330 + Irinotecan

Measure	Description	Time Frame
Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0		Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months

Name	Affiliation	Role
Michael Kurman, MD	Kyowa Hakko Kirin Pharma, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clearview Cancer Institute		Huntsville	Alabama	35805	United States
Arizona Clinical Research Center

ID	Title	Description
FG000	KRN330 + Irinotecan	Phase 1____ Biweekly KRN330 (0.5 mg/kg) (N=8) Weekly KRN330 (0.5 mg/kg) (N=7) Biweekly KRN330 (1.0 mg/kg) (N=4) Total (N=19) Phase 2____ Weekly KRN330 (0.5 mg/kg)) (N=46) Phase 1 and 2Combined (N=65)

ID	Title	Description
BG000	KRN330 + Irinotecan	open label, single arm

Units	Counts
Participants	BG00063

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly	In Regimen A, patients received both KRN330 and irinotecan biweekly (Weeks 1, 3, and 5): Cohort 1: KRN330 1.0 mg/kg + irinotecan 180 mg/m2 Cohort 2: KRN330 0.5 mg/kg + irinotecan 180 mg/m2	6	12	12	12
EG001	Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly	In Regimen B, patients received KRN330 0.5 mg/kg weekly (Weeks 1, 2, 3, 4, and 5) and irinotecan 180 mg/m2 biweekly (Weeks 1, 3, and 5)	2	7	7	7
EG002	Phase 2: KRN330 Weekly + IRI Biweekly	The Phase 2 portion had a single arm in which patients received Regimen B as included in the Phase 1 portion	17	44	42	44

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events1 affected12 at risk EG0010 events0 affected7 at risk EG0024 events4 affected44 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Colitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Ileus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events1 affected7 at risk EG0022 events2 affected44 at risk
Disease progression	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0028 events8 affected44 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Streptococcal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Clostridium difficile toxin test positive	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Metastatic pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected12 at risk EG0012 events1 affected7 at risk EG00216 events10 affected44 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected12 at risk EG0010 events0 affected7 at risk EG00216 events8 affected44 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events1 affected7 at risk EG0020 events0 affected44 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected12 at risk EG0010 events0 affected7 at risk EG00216 events7 affected44 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0023 events3 affected44 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0027 events7 affected44 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Cataract	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Diplopia	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Eye pain	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Lacrimation increased	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Ocular hyperaemia	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Swollen tear duct	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Vision blurred	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Visual impairment	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 events4 affected12 at risk EG0017 events3 affected7 at risk EG00222 events14 affected44 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events2 affected44 at risk
Abdominal wall mass	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Ascites	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Colitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected12 at risk EG0013 events1 affected7 at risk EG00224 events13 affected44 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00017 events10 affected12 at risk EG00112 events5 affected7 at risk EG00273 events33 affected44 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events2 affected44 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0025 events4 affected44 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected7 at risk EG0024 events4 affected44 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events2 affected44 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0021 events1 affected44 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00013 events9 affected12 at risk EG00117 events6 affected7 at risk EG00255 events29 affected44 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Oral pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Rectal discharge	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events3 affected44 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events2 affected44 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 events5 affected12 at risk EG00112 events6 affected7 at risk EG00228 events17 affected44 at risk
Application site rash	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0027 events5 affected44 at risk
Catheter site pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Chest discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Chills	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0023 events2 affected44 at risk
Discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected12 at risk EG00111 events4 affected7 at risk EG00254 events29 affected44 at risk
Gait disturbance	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Hypothermia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Infusion related reaction	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Malaise	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Mucosal inflammation	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0012 events2 affected7 at risk EG00213 events9 affected44 at risk
Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events3 affected44 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected12 at risk EG0010 events0 affected7 at risk EG0027 events7 affected44 at risk
Thirst	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Hypersensitivity	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0024 events2 affected44 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Fungal skin infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Furuncle	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Hordeolum	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Laryngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Lice infestation	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Oral candidiasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Osteomyelitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Parotitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Perirectal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events3 affected44 at risk
Skin infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Tooth abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events1 affected7 at risk EG0020 events0 affected44 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected12 at risk EG0011 events1 affected7 at risk EG0026 events6 affected44 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Procedural pain	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Procedural site reaction	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Alanine aminotransferase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0025 events5 affected44 at risk
Blood bicarbonate decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Blood creatinine increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Blood magnesium decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Blood potassium decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0024 events3 affected44 at risk
Blood pressure decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Blood pressure increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Blood sodium decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Blood uric acid increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Body temperature increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events3 affected44 at risk
Breath sounds abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Clostridium difficile toxin test positive	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Haemoglobin decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0026 events3 affected44 at risk
Neutrophil count decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events1 affected7 at risk EG0021 events1 affected44 at risk
Platelet count decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Skin turgor decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Weight decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected12 at risk EG0013 events2 affected7 at risk EG0029 events5 affected44 at risk
Weight increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
White blood cell count decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0022 events1 affected44 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected12 at risk EG0014 events2 affected7 at risk EG0020 events0 affected44 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG00225 events15 affected44 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected7 at risk EG00227 events14 affected44 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events2 affected44 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0024 events3 affected44 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected12 at risk EG0010 events0 affected7 at risk EG0025 events3 affected44 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected7 at risk EG0025 events3 affected44 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected7 at risk EG00211 events5 affected44 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Jaw disorder	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0024 events3 affected44 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0022 events2 affected44 at risk
Ageusia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Cholinergic syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected7 at risk EG00211 events8 affected44 at risk
Dysarthria	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Dysgeusia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected7 at risk EG0026 events4 affected44 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Lethargy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Memory impairment	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0021 events1 affected44 at risk
Paraesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Poor quality sleep	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Presyncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Agitation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Anxiety	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0023 events3 affected44 at risk
Confusional state	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0024 events4 affected44 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected12 at risk EG0010 events0 affected7 at risk EG0026 events5 affected44 at risk
Restlessness	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Dysuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events3 affected44 at risk
Incontinence	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Proteinuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0024 events3 affected44 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0014 events1 affected7 at risk EG0022 events2 affected44 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Haematospermia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Scrotal erythema	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Vulvovaginal burning sensation	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Asthma	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected12 at risk EG0015 events4 affected7 at risk EG0028 events7 affected44 at risk
Dysphonia	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0024 events3 affected44 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0028 events7 affected44 at risk
Epistaxis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0022 events2 affected44 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events3 affected44 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Rhinorrhoea	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected12 at risk EG0013 events3 affected7 at risk EG00220 events17 affected44 at risk
Dandruff	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0022 events2 affected44 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0024 events4 affected44 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0023 events2 affected44 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0014 events3 affected7 at risk EG0029 events4 affected44 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0016 events1 affected7 at risk EG00222 events8 affected44 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events1 affected44 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0020 events0 affected44 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected7 at risk EG0021 events1 affected44 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Flushing	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected12 at risk EG0010 events0 affected7 at risk EG0020 events0 affected44 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0022 events2 affected44 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected7 at risk EG0026 events6 affected44 at risk
Pallor	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected7 at risk EG0021 events1 affected44 at risk

ID	Term
D015179	Colorectal Neoplasms
D004067	Digestive System Neoplasms
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D007414	Intestinal Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D009369	Neoplasms
D005770	Gastrointestinal Neoplasms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds