Effort to Prevent Nosocomial Pneumonia Caused by Pseudomo... | NCT02696902

Name	Class
Innovative Medicines Initiative	OTHER
Antibacterial Resistance Leadership Group	OTHER
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Label	Type	Description	Intervention Names
MEDI3902 500 mg	Experimental	Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.	Drug: MEDI3902
Placebo	Placebo Comparator	Participants will receive a single IV dose of placebo matched to MEDI3902.	Other: Placebo
MEDI3902 1500 mg	Experimental	Participants will receive a single IV dose of 1500 mg MEDI3902.	Drug: MEDI3902

Name	Type	Description	Arm Group Labels	Other Names
MEDI3902	Drug	Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.	MEDI3902 1500 mg

Measure	Description	Time Frame
Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa	Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.	Day 1 through Day 22
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.	Day 1 through Day 50
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)	An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Day 1 through Day 50
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)	An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor. An AESI may be serious or non-serious.	Day 1 through Day 50

Measure	Description	Time Frame
Maximum Observed Concentration (Cmax) of MEDI3902	The Cmax of MEDI3902 is reported.	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902

Name	Affiliation	Role
MedImmune LLC	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Englewood	Colorado	80113	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
36380312	Derived	Chastre J, Francois B, Bourgeois M, Komnos A, Ferrer R, Rahav G, De Schryver N, Lepape A, Koksal I, Luyt CE, Sanchez-Garcia M, Torres A, Eggimann P, Koulenti D, Holland TL, Ali O, Shoemaker K, Ren P, Sauser J, Ruzin A, Tabor DE, Akhgar A, Wu Y, Jiang Y, DiGiandomenico A, Colbert S, Vandamme D, Coenjaerts F, Malhotra-Kumar S, Timbermont L, Oliver A, Barraud O, Bellamy T, Bonten M, Goossens H, Reisner C, Esser MT, Jafri HS; COMBACTE-MAGNET EVADE Study Group. Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial. Crit Care. 2022 Nov 15;26(1):355. doi: 10.1186/s13054-022-04204-9.

Label	URL
Redacted CSP for CT.gov results	View source

ID	Title	Description
FG000	Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
FG001	MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 6, 2018	Jan 19, 2021

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0005 events4 affected83 at risk EG0010 events0 affected16 at risk EG0024 events4 affected85 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0009 events5 affected83 at risk EG0010 events0 affected16 at risk EG00213 events8 affected85 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00010 events7 affected83 at risk EG0011 events1 affected16 at risk EG0022 events2 affected85 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0021 events1 affected85 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected16 at risk EG0024 events4 affected85 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0021 events1 affected85 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0012 events2 affected16 at risk EG0027 events4 affected85 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Bradycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0025 events3 affected85 at risk
Cardiac arrest	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0021 events1 affected85 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Cyanosis	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG00011 events7 affected83 at risk EG0010 events0 affected16 at risk EG0023 events3 affected85 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Diabetes insipidus	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Euthyroid sick syndrome	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hyperprolactinaemia	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Hypothyroidism	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Blindness unilateral	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Dry eye	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Noninfective conjunctivitis	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Ocular hyperaemia	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Pupils unequal	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0006 events6 affected83 at risk EG0013 events2 affected16 at risk EG0026 events3 affected85 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Aerophagia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Colitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00013 events11 affected83 at risk EG0015 events4 affected16 at risk EG00211 events11 affected85 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00016 events11 affected83 at risk EG0015 events4 affected16 at risk EG00214 events12 affected85 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0026 events6 affected85 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Flatulence	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Gastrointestinal oedema	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected16 at risk EG0021 events1 affected85 at risk
Ileus	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Intestinal dilatation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Lip haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Melaena	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 events3 affected83 at risk EG0015 events4 affected16 at risk EG0022 events1 affected85 at risk
Oesophagopleural fistula	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Oral mucosa haematoma	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Pancreatic failure	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Pancreatic necrosis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Perianal erythema	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events1 affected85 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected16 at risk EG0022 events2 affected85 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 events3 affected83 at risk EG0014 events2 affected16 at risk EG0026 events4 affected85 at risk
Asthenia	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Catheter site inflammation	General disorders	MedDRA 22.0	Systematic Assessment	EG0003 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Catheter site pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Chills	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Complication associated with device	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Generalised oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Granuloma	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hyperthermia	General disorders	MedDRA 22.0	Systematic Assessment	EG0004 events2 affected83 at risk EG0011 events1 affected16 at risk EG0022 events2 affected85 at risk
Hypothermia	General disorders	MedDRA 22.0	Systematic Assessment	EG0003 events2 affected83 at risk EG0010 events0 affected16 at risk EG0023 events2 affected85 at risk
Localised oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Medical device pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Medical device site dermatitis	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Medical device site haemorrhage	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Mucosal ulceration	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Non-cardiac chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected83 at risk EG0011 events1 affected16 at risk EG0024 events3 affected85 at risk
Pain	General disorders	MedDRA 22.0	Systematic Assessment	EG00015 events8 affected83 at risk EG0010 events0 affected16 at risk EG0027 events7 affected85 at risk
Peripheral swelling	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG00020 events13 affected83 at risk EG0011 events1 affected16 at risk EG00220 events16 affected85 at risk
Swelling	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Thirst	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Abdominal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Acinetobacter infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0025 events5 affected85 at risk
Anal fungal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected83 at risk EG0010 events0 affected16 at risk EG0025 events4 affected85 at risk
Bacterial abdominal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Bacterial disease carrier	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected16 at risk EG0025 events3 affected85 at risk
Bacterial infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Bacterial sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0024 events4 affected85 at risk
Bacteriuria	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Candida infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Candiduria	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Citrobacter bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0023 events2 affected85 at risk
Conjunctivitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events1 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Cystitis klebsiella	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Empyema	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Endocarditis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Enterobacter bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Enterobacter pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0022 events2 affected85 at risk
Enterococcal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events1 affected85 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected83 at risk EG0012 events1 affected16 at risk EG0024 events3 affected85 at risk
Eye infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Fungaemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Fungal skin infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Genital infection female	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Haematoma infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Herpes virus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Herpes zoster	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0023 events3 affected85 at risk
Klebsiella infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 events2 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Morganella infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Oral candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0023 events3 affected85 at risk
Oral fungal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Oral herpes	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected16 at risk EG0023 events3 affected85 at risk
Pneumonia acinetobacter	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00013 events12 affected83 at risk EG0012 events2 affected16 at risk EG0025 events4 affected85 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Pneumonia proteus	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00013 events12 affected83 at risk EG0011 events1 affected16 at risk EG00215 events13 affected85 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Proteus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected83 at risk EG0012 events1 affected16 at risk EG0021 events1 affected85 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0006 events6 affected83 at risk EG0010 events0 affected16 at risk EG0026 events6 affected85 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0006 events5 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Pseudomonas bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected83 at risk EG0014 events4 affected16 at risk EG0024 events4 affected85 at risk
Pseudomonas infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected83 at risk EG0010 events0 affected16 at risk EG0024 events4 affected85 at risk
Pyuria	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Septic shock	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Serratia bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Serratia sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected16 at risk EG0024 events4 affected85 at risk
Staphylococcal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Stenotrophomonas infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Stoma site infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Systemic candida	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Tracheobronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0012 events1 affected16 at risk EG0023 events3 affected85 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0023 events3 affected85 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0006 events5 affected83 at risk EG0010 events0 affected16 at risk EG0024 events4 affected85 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Dialysis related complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Eschar	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events1 affected16 at risk EG0020 events0 affected85 at risk
Flail chest	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Gastrostomy tube site complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Haemodilution	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Inflammation of wound	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Palate injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Post procedural inflammation	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Postoperative hypotension	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0023 events3 affected85 at risk
Scar	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Stoma site erythema	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Tracheal haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events1 affected85 at risk
Weaning failure	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Blood albumin decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Blood glucose increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Blood magnesium decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Blood potassium decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Blood sodium decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Blood urea increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0023 events3 affected85 at risk
C-reactive protein increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Electrocardiogram qt prolonged	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0021 events1 affected85 at risk
Inflammatory marker increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Oxygen saturation abnormal	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Oxygen saturation decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0009 events3 affected83 at risk EG0010 events0 affected16 at risk EG00210 events3 affected85 at risk
Pco2 increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Po2 decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0003 events1 affected83 at risk EG0010 events0 affected16 at risk EG0025 events1 affected85 at risk
Transaminases increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected16 at risk EG0021 events1 affected85 at risk
Urine output decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
White blood cell count increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0023 events1 affected85 at risk
Alkalosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0026 events1 affected85 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0025 events4 affected85 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0024 events3 affected85 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0011 events1 affected16 at risk EG0025 events5 affected85 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected83 at risk EG0010 events0 affected16 at risk EG0023 events3 affected85 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0022 events2 affected85 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00012 events9 affected83 at risk EG0011 events1 affected16 at risk EG00225 events15 affected85 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0023 events3 affected85 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0024 events4 affected85 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0025 events4 affected85 at risk
Vitamin k deficiency	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0022 events2 affected85 at risk
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Exposed bone in jaw	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0023 events1 affected85 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0004 events3 affected83 at risk EG0013 events3 affected16 at risk EG0022 events2 affected85 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0011 events1 affected16 at risk EG0023 events3 affected85 at risk
Aphasia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Complex regional pain syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Epilepsy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Frontotemporal dementia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0003 events2 affected83 at risk EG0010 events0 affected16 at risk EG0027 events4 affected85 at risk
Hydrocephalus	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Loss of consciousness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Motor dysfunction	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Myoclonus	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Paresis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Parkinsonism	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Post cardiac arrest syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Seizure	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Somnolence	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Syncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Tremor	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Stent malfunction	Product Issues	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Thrombosis in device	Product Issues	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Agitation	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0011 events1 affected16 at risk EG0023 events3 affected85 at risk
Anxiety	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0005 events4 affected83 at risk EG0013 events3 affected16 at risk EG0022 events2 affected85 at risk
Apathy	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Compulsive lip biting	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Delirium	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0025 events5 affected85 at risk
Depression	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0023 events3 affected85 at risk
Depressive symptom	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Disinhibition	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Disorientation	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected16 at risk EG0021 events1 affected85 at risk
Initial insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG00010 events9 affected83 at risk EG0010 events0 affected16 at risk EG0027 events7 affected85 at risk
Intensive care unit delirium	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Nervousness	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Restlessness	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Anuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Haematuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Oliguria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0006 events5 affected83 at risk EG0011 events1 affected16 at risk EG0025 events5 affected85 at risk
Polyuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Proteinuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Renal cyst	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Renal failure	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0025 events5 affected85 at risk
Renal impairment	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected16 at risk EG0022 events2 affected85 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Urinary retention	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Urine abnormality	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Vesical fistula	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Cervical cyst	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Genital pain	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Penile discharge	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Penile oedema	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Vulval disorder	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 events4 affected83 at risk EG0011 events1 affected16 at risk EG0024 events4 affected85 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected16 at risk EG0022 events2 affected85 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0022 events1 affected85 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0028 events5 affected85 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hypopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Increased bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Increased viscosity of bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected16 at risk EG0021 events1 affected85 at risk
Pleural disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0013 events3 affected16 at risk EG0024 events3 affected85 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Pulmonary fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0025 events2 affected85 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Respiratory fatigue	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Sputum retention	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 events2 affected83 at risk EG0011 events1 affected16 at risk EG0023 events3 affected85 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0006 events6 affected83 at risk EG0010 events0 affected16 at risk EG0026 events5 affected85 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0005 events3 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Generalised erythema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected16 at risk EG0025 events3 affected85 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events1 affected85 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0022 events2 affected85 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Artery dissection	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Extremity necrosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Haemodynamic instability	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0009 events7 affected83 at risk EG0015 events3 affected16 at risk EG0026 events3 affected85 at risk
Hypoperfusion	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG00021 events16 affected83 at risk EG0011 events1 affected16 at risk EG00229 events23 affected85 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Peripheral coldness	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Phlebitis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected16 at risk EG0020 events0 affected85 at risk
Vein disorder	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected16 at risk EG0020 events0 affected85 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk
Venous thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected16 at risk EG0021 events1 affected85 at risk

ID	Title	Description
BG000	Placebo	Of the 85 participants, 83 participants received single intravenous (IV) dose of placebo matched to MEDI3902.
BG001	MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
BG002	MEDI3902 1500 mg	Of the 87 participants, 85 participants received single IV dose of 1500 mg MEDI3902.
BG003	Total	Total of all reporting groups

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012141	Respiratory Tract Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.	19	83	35	83	79	83
EG001	MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.	3	16	4	16	15	16
EG002	MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.	24	85	38	85	82	85