Daunorubicin, Cytarabine, and Midostaurin in Treating Pat... | NCT00651261

Name	Class
National Cancer Institute (NCI)	NIH
Novartis Pharmaceuticals	INDUSTRY

Label	Type	Description	Intervention Names
Induction and consolidation chemotherapy plus midostaurin	Experimental	Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and the experimental drug midostaurin. Depending on the outcome of remission induction treatment, there may be a decision to discontinue the study treatment or a second remission induction cycle may be given. If remission induction therapy is successfully completed, patients will receive four courses of high-dose cytarabine consolidation chemotherapy plus dexamethasone together with the experimental drug midostaurin. All patients will undergo a bone marrow aspiration (and perhaps a biopsy) after the final course of remission consolidation chemotherapy. If the patient continues to respond to the treatment, the patient will receive continuation therapy with midostaurin for twelve (12) months.	Drug: cytarabine Drug: daunorubicin Drug: midostaurin Drug: dexamethasone acetate
Induction and consolidation chemotherapy plus placebo	Active Comparator	Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and placebo. Depending on the outcome of remission induction treatment, there may be a decision to discontinue the study treatment or a second remission induction cycle may be given. If remission induction therapy is successfully completed, patients will receive four courses of high-dose cytarabine consolidation chemotherapy plus dexamethasone together with placebo. All patients will undergo a bone marrow aspiration (and perhaps a biopsy) after the final course of remission consolidation chemotherapy. If the patient continues to respond to the treatment, the patient will receive continuation therapy with placebo for twelve (12) months.	Drug: cytarabine Drug: daunorubicin Other: placebo Drug: dexamethasone acetate

Name	Type	Description	Arm Group Labels	Other Names
cytarabine	Drug	Given IV	Induction and consolidation chemotherapy plus midostaurin Induction and consolidation chemotherapy plus placebo

Measure	Description	Time Frame
Overall Survival (OS)	Overall survival (OS) was defined as the time interval from randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.	Duration of study (Up to 10 years)

Measure	Description	Time Frame
Event- Free Survival	Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method. Due to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint.

Name	Affiliation	Role
Richard M. Stone, MD	Dana-Farber Cancer Institute	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
UAB Comprehensive Cancer Center		Birmingham	Alabama	35294	United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

PubMed Identifier	Type	Citation
	Result	Stone RM, Dohner H, Ehninger G, et al.: CALGB 10603 (RATIFY): A randomized phase III study of induction (daunorubicin/cytarabine) and consolidation (high-dose cytarabine) chemotherapy combined with midostaurin or placebo in treatment-naive patients with FLT3 mutated AML. [Abstract] J Clin Oncol 29 (Suppl 15): A-TPS199, 2011.
36184192	Derived	Seffernick AE, Mrozek K, Nicolet D, Stone RM, Eisfeld AK, Byrd JC, Archer KJ. High-dimensional genomic feature selection with the ordered stereotype logit model. Brief Bioinform. 2022 Nov 19;23(6):bbac414. doi: 10.1093/bib/bbac414.
33049054

ID	Title	Description
FG000	Induction and Consolidation Chemotherapy Plus Midostaurin	Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood disorder	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Bone marrow hypocellular	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG000144 events105 affected355 at risk EG001152 events110 affected354 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG000237 events154 affected355 at risk EG001230 events148 affected354 at risk
Hemolysis	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Lymphatic disorder	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0006 events6 affected355 at risk EG0014 events4 affected354 at risk
Arrhythmia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Asystole	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0016 events6 affected354 at risk
Atrial flutter	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Cardiac disorder	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0016 events6 affected354 at risk
Cardiac pain	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0011 events1 affected354 at risk
Cardiopulmonary arrest	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Conduction disorder	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Left ventricular failure	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0009 events8 affected355 at risk EG0017 events7 affected354 at risk
Myocardial ischemia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected354 at risk
Palpitations	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Pericardial effusion	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0015 events5 affected354 at risk
Pericarditis	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected354 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG00020 events17 affected355 at risk EG00120 events15 affected354 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events3 affected354 at risk
Ear disorder	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected354 at risk
External ear pain	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Middle ear inflammation	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Endocrine disorder	Endocrine disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Hypothyroidism	Endocrine disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Cataract	Eye disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Conjunctivitis	Eye disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Diplopia	Eye disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Dry eye syndrome	Eye disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected354 at risk
Eye disorder	Eye disorders	MedDRA 6	Systematic Assessment	EG0009 events8 affected355 at risk EG00112 events12 affected354 at risk
Eye pain	Eye disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Eyelid function disorder	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Flashing vision	Eye disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Keratitis	Eye disorders	MedDRA 6	Systematic Assessment	EG0006 events5 affected355 at risk EG0019 events8 affected354 at risk
Optic nerve edema	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Photophobia	Eye disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Retinal detachment	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Scleral disorder	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Vision blurred	Eye disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0014 events4 affected354 at risk
Watering eyes	Eye disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected354 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0012 events2 affected354 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00033 events29 affected355 at risk EG00132 events28 affected354 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Anal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Anal mucositis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Anal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG0015 events5 affected354 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Ascites	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Colitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0009 events9 affected355 at risk EG0019 events9 affected354 at risk
Colonic hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Colonic perforation	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Constipation	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00018 events16 affected355 at risk EG00118 events17 affected354 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG000111 events89 affected355 at risk EG001108 events89 affected354 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Duodenal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Duodenal necrosis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00011 events10 affected355 at risk EG0018 events8 affected354 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00010 events10 affected355 at risk EG00112 events10 affected354 at risk
Ear, nose and throat examination abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00052 events40 affected355 at risk EG00154 events42 affected354 at risk
Endoscopy small intestine abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Enteritis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Esophageal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Esophageal ulcer	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Esophagitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Flatulence	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG0016 events5 affected354 at risk
Gastric hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00012 events10 affected355 at risk EG00110 events10 affected354 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Hemorrhoidal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00014 events11 affected355 at risk EG0017 events7 affected354 at risk
Ileal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Ileal necrosis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Ileus	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0014 events4 affected354 at risk
Intestinal necrosis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Intra-abdominal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Jejunal necrosis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected354 at risk
Mucositis oral	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00023 events23 affected355 at risk EG00113 events11 affected354 at risk
Nausea	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG000149 events98 affected355 at risk EG001126 events91 affected354 at risk
Oral hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0006 events5 affected355 at risk EG00111 events10 affected354 at risk
Oral pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG0016 events5 affected354 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Proctitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected354 at risk
Rectal obstruction	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Rectal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Salivary gland disorder	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Stomach pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00012 events8 affected355 at risk EG0019 events9 affected354 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Toothache	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0014 events4 affected354 at risk
Typhlitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Vomiting	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG000101 events70 affected355 at risk EG00186 events65 affected354 at risk
Chest pain	General disorders	MedDRA 6	Systematic Assessment	EG0007 events6 affected355 at risk EG00112 events11 affected354 at risk
Chills	General disorders	MedDRA 6	Systematic Assessment	EG00021 events16 affected355 at risk EG00124 events16 affected354 at risk
Disease progression	General disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Edema limbs	General disorders	MedDRA 6	Systematic Assessment	EG00032 events26 affected355 at risk EG00124 events21 affected354 at risk
Facial pain	General disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Fatigue	General disorders	MedDRA 6	Systematic Assessment	EG000136 events95 affected355 at risk EG001130 events98 affected354 at risk
Fever	General disorders	MedDRA 6	Systematic Assessment	EG00038 events34 affected355 at risk EG00138 events33 affected354 at risk
Flu-like symptoms	General disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
General symptom	General disorders	MedDRA 6	Systematic Assessment	EG00014 events11 affected355 at risk EG00116 events15 affected354 at risk
Ill-defined disorder	General disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0014 events4 affected354 at risk
Injection site reaction	General disorders	MedDRA 6	Systematic Assessment	EG00017 events14 affected355 at risk EG00122 events17 affected354 at risk
Localized edema	General disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG00111 events9 affected354 at risk
Multi-organ failure	General disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0015 events5 affected354 at risk
Pain	General disorders	MedDRA 6	Systematic Assessment	EG00017 events14 affected355 at risk EG00124 events18 affected354 at risk
Sudden death	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Visceral edema	General disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0011 events1 affected354 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Hypersensitivity	Immune system disorders	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG00115 events14 affected354 at risk
Immune system disorder	Immune system disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0014 events3 affected354 at risk
Abdominal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events3 affected354 at risk
Anal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0009 events6 affected355 at risk EG0015 events5 affected354 at risk
Anorectal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Appendicitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Bladder infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected354 at risk
Bone infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Bronchitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0014 events3 affected354 at risk
Catheter related infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG00039 events29 affected355 at risk EG00126 events21 affected354 at risk
Colitis, infectious (e.g., Clostridium difficile)	Infections and infestations	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0012 events2 affected354 at risk
Conjunctivitis infective	Infections and infestations	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0013 events3 affected354 at risk
Eye infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Eye infection intraocular	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Gallbladder infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Gingival infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events2 affected354 at risk
Hepatic infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected354 at risk
Infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG00041 events30 affected355 at risk EG00133 events26 affected354 at risk
Infectious colitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0008 events8 affected355 at risk EG00110 events9 affected354 at risk
Joint infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Kidney infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Lip infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG0019 events8 affected354 at risk
Lymph gland infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Mucosal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Nail infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected354 at risk
Opportunistic infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0011 events1 affected354 at risk
Otitis externa	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Otitis media	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Paranasal sinus infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events3 affected354 at risk
Penile infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Pharyngitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0004 events3 affected355 at risk EG0012 events2 affected354 at risk
Phlebitis infective	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Pleural infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Pneumonia	Infections and infestations	MedDRA 6	Systematic Assessment	EG00032 events25 affected355 at risk EG00139 events35 affected354 at risk
Rhinitis infective	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Salivary gland infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Sepsis	Infections and infestations	MedDRA 6	Systematic Assessment	EG00027 events23 affected355 at risk EG00117 events16 affected354 at risk
Sinusitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Skin infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0009 events8 affected355 at risk EG0019 events8 affected354 at risk
Small intestine infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Soft tissue infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0014 events4 affected354 at risk
Splenic infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Tooth infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0015 events4 affected354 at risk
Upper aerodigestive tract infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Urinary tract infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG00010 events8 affected355 at risk EG00119 events15 affected354 at risk
Vulval infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Wound infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0012 events2 affected354 at risk
Bruising	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Intraoperative complications	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Intraoperative gastrointestinal injury	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Intraoperative gastrointestinal injury - Appendix	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Intraoperative reproductive tract injury - Ovary	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Intraoperative reproductive tract injury - Testis	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Kidney anastomotic leak	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Postoperative hemorrhage	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected354 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 6	Systematic Assessment	EG00015 events9 affected355 at risk EG00111 events9 affected354 at risk
Alanine aminotransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG00041 events35 affected355 at risk EG00141 events35 affected354 at risk
Alkaline phosphatase increased	Investigations	MedDRA 6	Systematic Assessment	EG0008 events8 affected355 at risk EG00124 events20 affected354 at risk
Amylase increased	Investigations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG00033 events30 affected355 at risk EG00132 events29 affected354 at risk
Blood bilirubin increased	Investigations	MedDRA 6	Systematic Assessment	EG00032 events25 affected355 at risk EG00142 events36 affected354 at risk
CD4 lymphocytes decreased	Investigations	MedDRA 6	Systematic Assessment	EG0003 events1 affected355 at risk EG0010 events0 affected354 at risk
Cardiac troponin T increased	Investigations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Coagulopathy	Investigations	MedDRA 6	Systematic Assessment	EG00014 events8 affected355 at risk EG00111 events7 affected354 at risk
Creatinine increased	Investigations	MedDRA 6	Systematic Assessment	EG00016 events15 affected355 at risk EG00117 events16 affected354 at risk
Electrocardiogram QTc interval prolonged	Investigations	MedDRA 6	Systematic Assessment	EG00022 events17 affected355 at risk EG00122 events19 affected354 at risk
Fibrinogen decreased	Investigations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0017 events7 affected354 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG00025 events19 affected355 at risk EG00132 events22 affected354 at risk
INR increased	Investigations	MedDRA 6	Systematic Assessment	EG00010 events8 affected355 at risk EG0015 events5 affected354 at risk
Laboratory test abnormal	Investigations	MedDRA 6	Systematic Assessment	EG00033 events18 affected355 at risk EG00147 events28 affected354 at risk
Leukocyte count decreased	Investigations	MedDRA 6	Systematic Assessment	EG00066 events41 affected355 at risk EG00178 events47 affected354 at risk
Lipase increased	Investigations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Lymphocyte count decreased	Investigations	MedDRA 6	Systematic Assessment	EG00030 events22 affected355 at risk EG00156 events36 affected354 at risk
Neutrophil count decreased	Investigations	MedDRA 6	Systematic Assessment	EG000227 events145 affected355 at risk EG001224 events146 affected354 at risk
Platelet count decreased	Investigations	MedDRA 6	Systematic Assessment	EG000239 events155 affected355 at risk EG001227 events146 affected354 at risk
Serum cholesterol increased	Investigations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Weight gain	Investigations	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected354 at risk
Weight loss	Investigations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG00113 events11 affected354 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00030 events21 affected355 at risk EG00129 events26 affected354 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00023 events17 affected355 at risk EG00131 events22 affected354 at risk
Blood uric acid increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00010 events6 affected355 at risk EG0014 events4 affected354 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Glucose intolerance	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00028 events19 affected355 at risk EG00126 events22 affected354 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00025 events20 affected355 at risk EG00130 events26 affected354 at risk
Serum calcium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Serum glucose decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events2 affected354 at risk
Serum magnesium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00019 events15 affected355 at risk EG00122 events15 affected354 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0009 events7 affected355 at risk EG00113 events12 affected354 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00037 events31 affected355 at risk EG00153 events47 affected354 at risk
Serum potassium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0009 events8 affected355 at risk EG0014 events4 affected354 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00022 events20 affected355 at risk EG00122 events20 affected354 at risk
Serum sodium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG0015 events5 affected354 at risk
Serum triglycerides increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0004 events3 affected355 at risk EG0010 events0 affected354 at risk
Tumor lysis syndrome	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0008 events8 affected355 at risk EG0016 events6 affected354 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG00019 events15 affected355 at risk EG00113 events13 affected354 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG0015 events4 affected354 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events2 affected354 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0014 events4 affected354 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0007 events7 affected355 at risk EG0015 events4 affected354 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG0015 events4 affected354 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0006 events5 affected355 at risk EG0019 events6 affected354 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Ataxia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events3 affected354 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Dizziness	Nervous system disorders	MedDRA 6	Systematic Assessment	EG00023 events19 affected355 at risk EG00125 events20 affected354 at risk
Dysgeusia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0019 events7 affected354 at risk
Encephalopathy	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Headache	Nervous system disorders	MedDRA 6	Systematic Assessment	EG00054 events41 affected355 at risk EG00163 events42 affected354 at risk
Intracranial hemorrhage	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0016 events6 affected354 at risk
Ischemia cerebrovascular	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Memory impairment	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Neuralgia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Neurological disorder NOS	Nervous system disorders	MedDRA 6	Systematic Assessment	EG00011 events9 affected355 at risk EG0014 events4 affected354 at risk
Nystagmus	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG00111 events6 affected354 at risk
Seizure	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Speech disorder	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0011 events1 affected354 at risk
Syncope	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0006 events6 affected355 at risk EG0014 events4 affected354 at risk
Syncope vasovagal	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Tremor	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0013 events3 affected354 at risk
Agitation	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0005 events3 affected355 at risk EG0013 events3 affected354 at risk
Anxiety	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG00111 events9 affected354 at risk
Confusion	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0013 events3 affected354 at risk
Depression	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG00112 events12 affected354 at risk
Euphoria	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Insomnia	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG00014 events11 affected355 at risk EG00111 events7 affected354 at risk
Personality change	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Psychosis	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0012 events2 affected354 at risk
Bladder hemorrhage	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Bladder pain	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Cystitis	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Glomerular filtration rate decreased	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Hemorrhage urinary tract	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0016 events6 affected354 at risk
Proteinuria	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Renal failure	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG00013 events13 affected355 at risk EG0019 events9 affected354 at risk
Renal hemorrhage	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Urethral pain	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Urinary frequency	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Urinary retention	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected354 at risk
Urine discoloration	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Urogenital disorder	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG00021 events15 affected355 at risk EG00115 events11 affected354 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Penile pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Reproductive tract disorder	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Uterine hemorrhage	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0005 events4 affected355 at risk EG0014 events3 affected354 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG0019 events9 affected354 at risk
Vaginal mucositis	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Vaginal pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0009 events9 affected355 at risk EG0015 events5 affected354 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0014 events3 affected354 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Bronchopulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00021 events17 affected355 at risk EG00120 events19 affected354 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00022 events20 affected355 at risk EG00124 events24 affected354 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00026 events24 affected355 at risk EG00124 events22 affected354 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0008 events8 affected355 at risk EG00112 events12 affected354 at risk
Laryngeal edema	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Laryngeal mucositis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Laryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Laryngoscopy abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Pharyngeal examination abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0012 events2 affected354 at risk
Pharyngeal mucositis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0006 events6 affected355 at risk EG00112 events11 affected354 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0008 events8 affected355 at risk EG0018 events8 affected354 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00028 events27 affected355 at risk EG00119 events17 affected354 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Pulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00012 events12 affected355 at risk EG0019 events9 affected354 at risk
Respiratory tract hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Retinoic acid syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Voice alteration	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0008 events6 affected355 at risk EG0014 events4 affected354 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG0017 events7 affected354 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected354 at risk
Hand-and-foot syndrome	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0004 events2 affected355 at risk EG0015 events5 affected354 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00045 events35 affected355 at risk EG00152 events34 affected354 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00013 events11 affected355 at risk EG00113 events12 affected354 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00070 events59 affected355 at risk EG00171 events66 affected354 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00028 events23 affected355 at risk EG00130 events23 affected354 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Sweating	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00019 events14 affected355 at risk EG00115 events14 affected354 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0014 events3 affected354 at risk
Flushing	Vascular disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Hematoma	Vascular disorders	MedDRA 6	Systematic Assessment	EG00017 events14 affected355 at risk EG00117 events13 affected354 at risk
Hemorrhage	Vascular disorders	MedDRA 6	Systematic Assessment	EG00019 events14 affected355 at risk EG00113 events12 affected354 at risk
Hot flashes	Vascular disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Hypertension	Vascular disorders	MedDRA 6	Systematic Assessment	EG00013 events13 affected355 at risk EG00111 events11 affected354 at risk
Hypotension	Vascular disorders	MedDRA 6	Systematic Assessment	EG00026 events25 affected355 at risk EG00122 events19 affected354 at risk
Lymphangitic streak	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Lymphedema	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Phlebitis	Vascular disorders	MedDRA 6	Systematic Assessment	EG0007 events6 affected355 at risk EG0017 events7 affected354 at risk
Thrombosis	Vascular disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Vascular disorder	Vascular disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Vasculitis	Vascular disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood disorder	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG00011 events5 affected355 at risk EG0016 events4 affected354 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG000422 events246 affected355 at risk EG001394 events238 affected354 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0001,059 events312 affected355 at risk EG001940 events311 affected354 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Lymphatic disorder	Blood and lymphatic system disorders	MedDRA 6	Systematic Assessment	EG00013 events10 affected355 at risk EG00111 events9 affected354 at risk
Arrhythmia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0014 events4 affected354 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected354 at risk
Atrial flutter	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0003 events1 affected355 at risk EG0011 events1 affected354 at risk
Cardiac disorder	Cardiac disorders	MedDRA 6	Systematic Assessment	EG00012 events8 affected355 at risk EG00117 events13 affected354 at risk
Cardiac pain	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0006 events4 affected355 at risk EG0011 events1 affected354 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Conduction disorder	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Left ventricular failure	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0006 events6 affected355 at risk EG0019 events5 affected354 at risk
Myocardial ischemia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Palpitations	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG00113 events5 affected354 at risk
Pericardial effusion	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG0011 events1 affected354 at risk
Pericarditis	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Premature ventricular contractions	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0003 events1 affected355 at risk EG0010 events0 affected354 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG00010 events10 affected355 at risk EG00115 events5 affected354 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG00013 events11 affected355 at risk EG00129 events23 affected354 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0017 events2 affected354 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Ventricular bigeminy	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0002 events1 affected355 at risk EG0010 events0 affected354 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Ear disorder	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG0013 events3 affected354 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0006 events5 affected355 at risk EG0016 events6 affected354 at risk
External ear inflammation	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
External ear pain	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0012 events2 affected354 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0004 events2 affected355 at risk EG0012 events2 affected354 at risk
Middle ear inflammation	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0012 events2 affected354 at risk
Endocrine disorder	Endocrine disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 6	Systematic Assessment	EG0007 events2 affected355 at risk EG0013 events1 affected354 at risk
Hypothyroidism	Endocrine disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0015 events2 affected354 at risk
Cataract	Eye disorders	MedDRA 6	Systematic Assessment	EG0009 events1 affected355 at risk EG0010 events0 affected354 at risk
Conjunctivitis	Eye disorders	MedDRA 6	Systematic Assessment	EG0007 events7 affected355 at risk EG0015 events4 affected354 at risk
Dry eye syndrome	Eye disorders	MedDRA 6	Systematic Assessment	EG0007 events5 affected355 at risk EG00112 events10 affected354 at risk
Eye disorder	Eye disorders	MedDRA 6	Systematic Assessment	EG00028 events21 affected355 at risk EG00119 events16 affected354 at risk
Eye pain	Eye disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG0015 events5 affected354 at risk
Eyelid function disorder	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Flashing vision	Eye disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0015 events4 affected354 at risk
Keratitis	Eye disorders	MedDRA 6	Systematic Assessment	EG00017 events14 affected355 at risk EG00114 events9 affected354 at risk
Optic nerve disorder	Eye disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Photophobia	Eye disorders	MedDRA 6	Systematic Assessment	EG0003 events2 affected355 at risk EG0014 events4 affected354 at risk
Vision blurred	Eye disorders	MedDRA 6	Systematic Assessment	EG0008 events5 affected355 at risk EG0017 events4 affected354 at risk
Vitreous hemorrhage	Eye disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Watering eyes	Eye disorders	MedDRA 6	Systematic Assessment	EG0007 events4 affected355 at risk EG0012 events2 affected354 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00015 events6 affected355 at risk EG00111 events10 affected354 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00078 events57 affected355 at risk EG00184 events67 affected354 at risk
Anal exam abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events3 affected354 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Anal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected354 at risk
Anal mucositis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events2 affected354 at risk
Anal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00015 events12 affected355 at risk EG0018 events6 affected354 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events3 affected354 at risk
Ascites	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Colitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0009 events7 affected355 at risk EG00118 events12 affected354 at risk
Colonic hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Colonic perforation	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events1 affected354 at risk
Constipation	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00086 events50 affected355 at risk EG00183 events60 affected354 at risk
Dental prosthesis user	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG000432 events228 affected355 at risk EG001310 events219 affected354 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00036 events22 affected355 at risk EG00117 events16 affected354 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0006 events6 affected355 at risk EG00110 events10 affected354 at risk
Ear, nose and throat examination abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG000178 events112 affected355 at risk EG001169 events112 affected354 at risk
Endoscopy large bowel abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Enteritis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events3 affected354 at risk
Esophageal mucositis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Esophageal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events3 affected354 at risk
Esophageal perforation	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Esophageal ulcer	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Esophagitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0014 events4 affected354 at risk
Flatulence	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00020 events10 affected355 at risk EG0018 events7 affected354 at risk
Gastric hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Gastric mucositis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Gastritis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0014 events4 affected354 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00035 events28 affected355 at risk EG00129 events26 affected354 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Gastroscopy abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events3 affected354 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0014 events4 affected354 at risk
Hemorrhoidal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events2 affected354 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00036 events28 affected355 at risk EG00125 events21 affected354 at risk
Ileal obstruction	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Ileus	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0003 events2 affected355 at risk EG0013 events3 affected354 at risk
Large intestinal mucositis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Mucositis oral	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00059 events49 affected355 at risk EG00136 events31 affected354 at risk
Nausea	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG000807 events258 affected355 at risk EG001449 events226 affected354 at risk
Oesophagoscopy abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Oral hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00013 events12 affected355 at risk EG00127 events18 affected354 at risk
Oral pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00010 events8 affected355 at risk EG00111 events11 affected354 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0006 events4 affected355 at risk EG0017 events7 affected354 at risk
Peritoneal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Proctitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Proctoscopy abnormal	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected354 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG0017 events5 affected354 at risk
Rectal obstruction	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Rectal pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0006 events5 affected355 at risk EG0012 events2 affected354 at risk
Salivary gland disorder	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Small intestinal mucositis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Stomach pain	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00043 events34 affected355 at risk EG00132 events27 affected354 at risk
Tooth development disorder	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0006 events6 affected355 at risk EG0012 events2 affected354 at risk
Toothache	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG00011 events9 affected355 at risk EG00110 events10 affected354 at risk
Typhlitis	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0014 events4 affected354 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Vomiting	Gastrointestinal disorders	MedDRA 6	Systematic Assessment	EG000376 events188 affected355 at risk EG001259 events168 affected354 at risk
Chest pain	General disorders	MedDRA 6	Systematic Assessment	EG00017 events15 affected355 at risk EG00128 events20 affected354 at risk
Chills	General disorders	MedDRA 6	Systematic Assessment	EG00026 events22 affected355 at risk EG00121 events17 affected354 at risk
Disease progression	General disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Edema limbs	General disorders	MedDRA 6	Systematic Assessment	EG00043 events33 affected355 at risk EG00156 events39 affected354 at risk
Facial pain	General disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Fatigue	General disorders	MedDRA 6	Systematic Assessment	EG000522 events221 affected355 at risk EG001474 events220 affected354 at risk
Fever	General disorders	MedDRA 6	Systematic Assessment	EG000110 events72 affected355 at risk EG001107 events69 affected354 at risk
Flu-like symptoms	General disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG0012 events2 affected354 at risk
Gait abnormal	General disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
General symptom	General disorders	MedDRA 6	Systematic Assessment	EG00018 events15 affected355 at risk EG00125 events17 affected354 at risk
Hypothermia	General disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Ill-defined disorder	General disorders	MedDRA 6	Systematic Assessment	EG0004 events3 affected355 at risk EG0014 events4 affected354 at risk
Injection site reaction	General disorders	MedDRA 6	Systematic Assessment	EG00025 events20 affected355 at risk EG00134 events23 affected354 at risk
Localized edema	General disorders	MedDRA 6	Systematic Assessment	EG00016 events16 affected355 at risk EG00119 events14 affected354 at risk
Pain	General disorders	MedDRA 6	Systematic Assessment	EG00055 events40 affected355 at risk EG00144 events33 affected354 at risk
Visceral edema	General disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Gallbladder pain	Hepatobiliary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 6	Systematic Assessment	EG00016 events4 affected355 at risk EG0015 events4 affected354 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 6	Systematic Assessment	EG0002 events1 affected355 at risk EG0010 events0 affected354 at risk
Hypersensitivity	Immune system disorders	MedDRA 6	Systematic Assessment	EG00041 events36 affected355 at risk EG00141 events30 affected354 at risk
Immune system disorder	Immune system disorders	MedDRA 6	Systematic Assessment	EG00014 events12 affected355 at risk EG00114 events9 affected354 at risk
Abdominal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Anal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0009 events8 affected355 at risk EG00112 events8 affected354 at risk
Anorectal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0003 events2 affected355 at risk EG0011 events1 affected354 at risk
Appendicitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Bladder infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG00013 events8 affected355 at risk EG00111 events10 affected354 at risk
Bone infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Bronchitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0009 events7 affected355 at risk EG0016 events6 affected354 at risk
Catheter related infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG00074 events55 affected355 at risk EG00154 events43 affected354 at risk
Cecal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events1 affected354 at risk
Colitis, infectious (e.g., Clostridium difficile)	Infections and infestations	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0014 events4 affected354 at risk
Conjunctivitis infective	Infections and infestations	MedDRA 6	Systematic Assessment	EG00010 events8 affected355 at risk EG0017 events5 affected354 at risk
Device related infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Eye infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Gastric infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events2 affected354 at risk
Gingival infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0006 events5 affected355 at risk EG0013 events3 affected354 at risk
Hepatic infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG00114 events5 affected354 at risk
Infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG000100 events57 affected355 at risk EG00199 events60 affected354 at risk
Infectious colitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0007 events5 affected355 at risk EG0015 events5 affected354 at risk
Kidney infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Lip infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG00022 events17 affected355 at risk EG00129 events21 affected354 at risk
Lymph gland infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0014 events3 affected354 at risk
Mediastinal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Mucosal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Nail infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0004 events3 affected355 at risk EG0012 events2 affected354 at risk
Opportunistic infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0005 events4 affected355 at risk EG00114 events9 affected354 at risk
Otitis media	Infections and infestations	MedDRA 6	Systematic Assessment	EG0003 events2 affected355 at risk EG0010 events0 affected354 at risk
Paranasal sinus infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Penile infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Pharyngitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG0017 events7 affected354 at risk
Phlebitis infective	Infections and infestations	MedDRA 6	Systematic Assessment	EG0005 events3 affected355 at risk EG0012 events2 affected354 at risk
Pneumonia	Infections and infestations	MedDRA 6	Systematic Assessment	EG00053 events36 affected355 at risk EG00145 events36 affected354 at risk
Rhinitis infective	Infections and infestations	MedDRA 6	Systematic Assessment	EG00012 events6 affected355 at risk EG0017 events6 affected354 at risk
Scrotal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Sepsis	Infections and infestations	MedDRA 6	Systematic Assessment	EG00029 events26 affected355 at risk EG00123 events20 affected354 at risk
Sinusitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0007 events7 affected355 at risk EG0016 events5 affected354 at risk
Skin infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG00024 events22 affected355 at risk EG00119 events15 affected354 at risk
Soft tissue infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Splenic infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0019 events2 affected354 at risk
Tooth infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0015 events4 affected354 at risk
Tracheitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Upper aerodigestive tract infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0014 events4 affected354 at risk
Upper respiratory infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG00017 events11 affected355 at risk EG00114 events8 affected354 at risk
Ureteritis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0006 events4 affected355 at risk EG0016 events4 affected354 at risk
Urinary tract infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG00017 events15 affected355 at risk EG00119 events15 affected354 at risk
Vaginal infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0006 events5 affected355 at risk EG00112 events8 affected354 at risk
Viral hepatitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Vulval infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Vulvitis	Infections and infestations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Wound infection	Infections and infestations	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0013 events3 affected354 at risk
Bruising	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0011 events1 affected354 at risk
Device complication	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Injury to inferior vena cava	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Injury to jugular vein	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Intraoperative complications	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Intraoperative gastrointestinal injury	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Intraoperative gastrointestinal injury - Teeth	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Intraoperative head and neck injury - Neck NOS	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Intraoperative ocular injury - Lens	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0002 events1 affected355 at risk EG0010 events0 affected354 at risk
Postoperative hemorrhage	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Radiation recall reaction (dermatologic)	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events3 affected354 at risk
Tracheostomy site bleeding	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Vaginal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG00015 events9 affected355 at risk EG0016 events6 affected354 at risk
Venous injury - Extremity-lower	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 6	Systematic Assessment	EG00036 events26 affected355 at risk EG00127 events22 affected354 at risk
Alanine aminotransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG000312 events88 affected355 at risk EG001184 events83 affected354 at risk
Alkaline phosphatase increased	Investigations	MedDRA 6	Systematic Assessment	EG00060 events30 affected355 at risk EG00155 events29 affected354 at risk
Amylase increased	Investigations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG000201 events60 affected355 at risk EG001102 events56 affected354 at risk
Blood bilirubin increased	Investigations	MedDRA 6	Systematic Assessment	EG00086 events49 affected355 at risk EG001104 events60 affected354 at risk
Cardiac troponin T increased	Investigations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Coagulopathy	Investigations	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG00114 events10 affected354 at risk
Creatinine increased	Investigations	MedDRA 6	Systematic Assessment	EG00018 events13 affected355 at risk EG00125 events15 affected354 at risk
Electrocardiogram QTc interval prolonged	Investigations	MedDRA 6	Systematic Assessment	EG00081 events45 affected355 at risk EG00148 events36 affected354 at risk
Fibrinogen decreased	Investigations	MedDRA 6	Systematic Assessment	EG00014 events12 affected355 at risk EG00110 events8 affected354 at risk
Forced expiratory volume decreased	Investigations	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 6	Systematic Assessment	EG00055 events25 affected355 at risk EG00157 events34 affected354 at risk
INR increased	Investigations	MedDRA 6	Systematic Assessment	EG00011 events9 affected355 at risk EG00112 events12 affected354 at risk
Laboratory test abnormal	Investigations	MedDRA 6	Systematic Assessment	EG00053 events31 affected355 at risk EG00181 events41 affected354 at risk
Leukocyte count decreased	Investigations	MedDRA 6	Systematic Assessment	EG000240 events79 affected355 at risk EG001204 events92 affected354 at risk
Lymphocyte count decreased	Investigations	MedDRA 6	Systematic Assessment	EG000195 events69 affected355 at risk EG001158 events71 affected354 at risk
Neutrophil count decreased	Investigations	MedDRA 6	Systematic Assessment	EG000952 events308 affected355 at risk EG001879 events308 affected354 at risk
Platelet count decreased	Investigations	MedDRA 6	Systematic Assessment	EG0001,131 events311 affected355 at risk EG0011,020 events313 affected354 at risk
Serum cholesterol increased	Investigations	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG00110 events5 affected354 at risk
Weight gain	Investigations	MedDRA 6	Systematic Assessment	EG00026 events15 affected355 at risk EG00111 events6 affected354 at risk
Weight loss	Investigations	MedDRA 6	Systematic Assessment	EG00012 events9 affected355 at risk EG00112 events10 affected354 at risk
Alkalosis	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events3 affected354 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00040 events30 affected355 at risk EG00150 events40 affected354 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG000202 events72 affected355 at risk EG001134 events59 affected354 at risk
Blood uric acid increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00042 events21 affected355 at risk EG00123 events15 affected354 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Glucose intolerance	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0015 events2 affected354 at risk
Iron overload	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0014 events2 affected354 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG000101 events56 affected355 at risk EG00180 events56 affected354 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00088 events58 affected355 at risk EG00179 events56 affected354 at risk
Serum calcium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00011 events6 affected355 at risk EG0012 events1 affected354 at risk
Serum glucose decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0008 events6 affected355 at risk EG00110 events9 affected354 at risk
Serum magnesium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00048 events30 affected355 at risk EG00165 events32 affected354 at risk
Serum magnesium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0008 events7 affected355 at risk EG0013 events3 affected354 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00031 events27 affected355 at risk EG00140 events27 affected354 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG000117 events79 affected355 at risk EG001112 events74 affected354 at risk
Serum potassium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG0016 events5 affected354 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG00063 events48 affected355 at risk EG00164 events51 affected354 at risk
Serum sodium increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0008 events8 affected355 at risk EG0019 events8 affected354 at risk
Serum triglycerides increased	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0015 events4 affected354 at risk
Tumor lysis syndrome	Metabolism and nutrition disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected354 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG00067 events30 affected355 at risk EG00125 events16 affected354 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG00074 events46 affected355 at risk EG00153 events34 affected354 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG00032 events19 affected355 at risk EG00137 events21 affected354 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0010 events0 affected354 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0009 events6 affected355 at risk EG0014 events3 affected354 at risk
Joint disorder	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Joint range of motion decreased lumbar spine	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0002 events1 affected355 at risk EG0010 events0 affected354 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0006 events6 affected355 at risk EG0014 events4 affected354 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG00019 events13 affected355 at risk EG0018 events6 affected354 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG00024 events13 affected355 at risk EG00119 events16 affected354 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG00018 events16 affected355 at risk EG0019 events9 affected354 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG00039 events30 affected355 at risk EG00123 events17 affected354 at risk
Upper extremity dysfunction	Musculoskeletal and connective tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Myelodysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Treatment related secondary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events1 affected354 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Ataxia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG00111 events10 affected354 at risk
Cognitive disturbance	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0013 events3 affected354 at risk
Dizziness	Nervous system disorders	MedDRA 6	Systematic Assessment	EG00064 events44 affected355 at risk EG00155 events43 affected354 at risk
Dysgeusia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0005 events5 affected355 at risk EG00114 events11 affected354 at risk
Encephalopathy	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0015 events1 affected354 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0015 events2 affected354 at risk
Headache	Nervous system disorders	MedDRA 6	Systematic Assessment	EG000218 events105 affected355 at risk EG001143 events85 affected354 at risk
Intracranial hemorrhage	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Memory impairment	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0004 events2 affected355 at risk EG0012 events1 affected354 at risk
Neuralgia	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0016 events3 affected354 at risk
Neurological disorder NOS	Nervous system disorders	MedDRA 6	Systematic Assessment	EG00022 events17 affected355 at risk EG0017 events7 affected354 at risk
Olfactory nerve disorder	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 6	Systematic Assessment	EG00012 events2 affected355 at risk EG0011 events1 affected354 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 6	Systematic Assessment	EG00021 events6 affected355 at risk EG00126 events11 affected354 at risk
Pyramidal tract syndrome	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Seizure	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Speech disorder	Nervous system disorders	MedDRA 6	Systematic Assessment	EG00016 events1 affected355 at risk EG0011 events1 affected354 at risk
Syncope	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0009 events8 affected355 at risk EG0016 events6 affected354 at risk
Syncope vasovagal	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0003 events2 affected355 at risk EG0019 events7 affected354 at risk
Tremor	Nervous system disorders	MedDRA 6	Systematic Assessment	EG0008 events5 affected355 at risk EG0014 events4 affected354 at risk
Agitation	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0013 events3 affected354 at risk
Anxiety	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG00021 events16 affected355 at risk EG00132 events18 affected354 at risk
Confusion	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0005 events4 affected355 at risk EG0014 events4 affected354 at risk
Depression	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG00026 events14 affected355 at risk EG00150 events24 affected354 at risk
Euphoria	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Insomnia	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG00047 events30 affected355 at risk EG00135 events20 affected354 at risk
Personality change	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Psychosis	Psychiatric disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Bladder hemorrhage	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Bladder pain	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0005 events3 affected355 at risk EG0011 events1 affected354 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Cystitis	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0006 events5 affected355 at risk EG0018 events7 affected354 at risk
Hemoglobin urine positive	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Hemorrhage urinary tract	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0014 events4 affected354 at risk
Kidney pain	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0002 events1 affected355 at risk EG0010 events0 affected354 at risk
Proteinuria	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0003 events1 affected355 at risk EG0011 events1 affected354 at risk
Renal failure	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0011 events1 affected354 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Urethral pain	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events2 affected354 at risk
Urinary frequency	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0019 events4 affected354 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Urinary retention	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events2 affected354 at risk
Urine discoloration	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Urogenital disorder	Renal and urinary disorders	MedDRA 6	Systematic Assessment	EG00012 events11 affected355 at risk EG00111 events10 affected354 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Gynecomastia	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events1 affected354 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Reproductive tract disorder	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Uterine hemorrhage	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG00012 events8 affected355 at risk EG0017 events6 affected354 at risk
Uterine pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events3 affected354 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events1 affected354 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG00017 events16 affected355 at risk EG00124 events17 affected354 at risk
Vaginal inflammation	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Vaginal mucositis	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Vaginal pain	Reproductive system and breast disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0011 events1 affected354 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG00114 events8 affected354 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0012 events2 affected354 at risk
Bronchopulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00057 events38 affected355 at risk EG00151 events41 affected354 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00033 events28 affected355 at risk EG00130 events29 affected354 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00063 events55 affected355 at risk EG00162 events46 affected354 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0009 events9 affected355 at risk EG00111 events11 affected354 at risk
Laryngeal edema	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Laryngeal mucositis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0013 events2 affected354 at risk
Laryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0011 events1 affected354 at risk
Laryngoscopy abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events1 affected354 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0016 events4 affected354 at risk
Pharyngeal examination abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0016 events6 affected354 at risk
Pharyngeal mucositis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0004 events4 affected355 at risk EG0011 events1 affected354 at risk
Pharyngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00035 events28 affected355 at risk EG00130 events25 affected354 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0009 events9 affected355 at risk EG0016 events6 affected354 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00033 events23 affected355 at risk EG00140 events33 affected354 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG00023 events17 affected355 at risk EG00131 events21 affected354 at risk
Voice alteration	Respiratory, thoracic and mediastinal disorders	MedDRA 6	Systematic Assessment	EG0004 events3 affected355 at risk EG0011 events1 affected354 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00010 events8 affected355 at risk EG0019 events6 affected354 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00013 events11 affected355 at risk EG00112 events9 affected354 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Hand-and-foot syndrome	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0009 events8 affected355 at risk EG00111 events9 affected354 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0003 events1 affected355 at risk EG0010 events0 affected354 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0003 events3 affected355 at risk EG0012 events2 affected354 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00089 events67 affected355 at risk EG00168 events51 affected354 at risk
Photosensitivity	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0005 events3 affected355 at risk EG0010 events0 affected354 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00031 events25 affected355 at risk EG00141 events31 affected354 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0012 events2 affected354 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG000358 events201 affected355 at risk EG001317 events200 affected354 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00067 events44 affected355 at risk EG00158 events42 affected354 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0003 events1 affected355 at risk EG0014 events3 affected354 at risk
Skin induration	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0012 events1 affected354 at risk
Skin striae	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected354 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0006 events5 affected355 at risk EG0018 events6 affected354 at risk
Sweating	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG00050 events30 affected355 at risk EG00132 events19 affected354 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 6	Systematic Assessment	EG0007 events6 affected355 at risk EG0015 events5 affected354 at risk
Flushing	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0013 events2 affected354 at risk
Hematoma	Vascular disorders	MedDRA 6	Systematic Assessment	EG00040 events32 affected355 at risk EG00139 events34 affected354 at risk
Hemorrhage	Vascular disorders	MedDRA 6	Systematic Assessment	EG00022 events15 affected355 at risk EG00133 events31 affected354 at risk
Hot flashes	Vascular disorders	MedDRA 6	Systematic Assessment	EG0004 events2 affected355 at risk EG0014 events4 affected354 at risk
Hypertension	Vascular disorders	MedDRA 6	Systematic Assessment	EG00021 events15 affected355 at risk EG00125 events13 affected354 at risk
Hypotension	Vascular disorders	MedDRA 6	Systematic Assessment	EG00037 events32 affected355 at risk EG00136 events32 affected354 at risk
Lymphedema	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Lymphocele	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk
Phlebitis	Vascular disorders	MedDRA 6	Systematic Assessment	EG00019 events13 affected355 at risk EG00117 events15 affected354 at risk
Thrombosis	Vascular disorders	MedDRA 6	Systematic Assessment	EG0006 events6 affected355 at risk EG0013 events3 affected354 at risk
Vascular disorder	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0014 events4 affected354 at risk
Vasculitis	Vascular disorders	MedDRA 6	Systematic Assessment	EG0002 events2 affected355 at risk EG0010 events0 affected354 at risk
Visceral arterial ischemia	Vascular disorders	MedDRA 6	Systematic Assessment	EG0000 events0 affected355 at risk EG0011 events1 affected354 at risk

ID	Type	Description
CALGB-10603
EUDRACT-2006-006852-37
CDR0000590404	Registry Identifier	Phyisician Data Query

ID	Title	Description
BG000	Induction and Consolidation Chemotherapy Plus Midostaurin	Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
BG001	Induction and Consolidation Chemotherapy Plus Placebo	Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
BG002	Total	Total of all reporting groups

ID	Term
D007938	Leukemia
D015471	Leukemia, Basophilic, Acute
D015472	Leukemia, Eosinophilic, Acute
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007947	Leukemia, Megakaryoblastic, Acute
D007948	Leukemia, Monocytic, Acute
D015470	Leukemia, Myeloid, Acute
D000013	Congenital Abnormalities
D015479	Leukemia, Myelomonocytic, Acute
D004915	Leukemia, Erythroblastic, Acute

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007951	Leukemia, Myeloid
D007945	Leukemia, Lymphoid
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases

ID	Term
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001087	Arabinonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Induction and Consolidation Chemotherapy Plus Midostaurin	Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.			157	355	321	355
EG001	Induction and Consolidation Chemotherapy Plus Placebo	Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.			154	354	324	354

ID	Term
D003561	Cytarabine
D003630	Daunorubicin
C059539	midostaurin
C018038	dexamethasone acetate