Determination of Safe and Effective Dose of Romiplostim (... | NCT00321711

Label	Type	Description	Intervention Names
Dose level 1 500 AMG 531 (Part A - azacitidine)	Active Comparator	500 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles	Biological: AMG 531 (Romiplostim) Drug: Azacitidine
Dose level 1 750 AMG 531 (Part B - decitabine)	Active Comparator	750 mcg AMG 531 weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles	Biological: AMG 531 (Romiplostim) Drug: Decitabine
Dose level 2 750 AMG 531 (Part A - azacitidine)	Active Comparator	750 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles	Biological: AMG 531 (Romiplostim) Drug: Azacitidine
Placebo (Part A - azacitidine)	Placebo Comparator	Placebo weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles	Drug: Placebo Drug: Azacitidine
Placebo (Part B - decitabine)	Placebo Comparator	Placebo weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period.	Placebo (Part A - azacitidine)

Measure	Description	Time Frame
Occurrence of a Clinically Significant Thrombocytopenic Event	Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10^9/L or receipt of platelet transfusions at any time through the interim follow-up visit.	Treatment period (up to 20 weeks)

Measure	Description	Time Frame
Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia	Occurrence of hypomethylating agent dose reduction and delay due to thrombocytopenia	Treatment period (up to 20 weeks)
Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period

Name	Affiliation	Role
MD	Amgen	Study Director

PubMed Identifier	Type	Citation	Retractions
22906162	Background	Greenberg PL, Garcia-Manero G, Moore M, Damon L, Roboz G, Hu K, Yang AS, Franklin J. A randomized controlled trial of romiplostim in patients with low- or intermediate-risk myelodysplastic syndrome receiving decitabine. Leuk Lymphoma. 2013 Feb;54(2):321-8. doi: 10.3109/10428194.2012.713477. Epub 2012 Nov 15.
20631375	Background

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Romiplostim (AMG 531) Placebo Plus Azacitidine	Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
FG001	Romiplostim (AMG 531) 500 mcg Plus Azacitidine

ID	Title	Description
BG000	Romiplostim (AMG 531) Placebo Plus Azacitidine	Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
BG001	Romiplostim (AMG 531) 500 mcg Plus Azacitidine	500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
BG002	Romiplostim (AMG 531) 750 mcg Plus Azacitidine	750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
BG003	Romiplostim (AMG 531) Placebo Plus Decitabine	Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
BG004	Romiplostim (AMG 531) 750 mcg Plus Decitabine	750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG00013 BG00113 BG00214 BG00314 BG00415 BG00569

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A Placebo	9	13	11	13
EG001	Part A Romiplostim 500 µg	4	13	13	13
EG002	Part A Romiplostim 750 µg	10	14	14	14
EG003	Part B Placebo	8	14	14	14
EG004	Part B Romiplostim 750 µg	8	15	14	15

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG0030 affected14 at risk EG0040 affected15 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Caecitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Appendicitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Endocarditis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Implant site infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Convulsion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Somnolence	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Syncope	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Disorientation	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Haematoma	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected13 at risk EG0011 affected13 at risk EG0022 affected14 at risk EG0034 affected14 at risk EG0042 affected15 at risk
Anaemia haemolytic autoimmune	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Bone marrow disorder	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected13 at risk EG0014 affected13 at risk EG0022 affected14 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0012 affected13 at risk EG0020 affected14 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Left ventricular hypertrophy	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Ear congestion	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Abnormal sensation in eye	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Eye pain	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Anal pruritus	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected13 at risk EG0017 affected13 at risk EG0027 affected14 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0014 affected13 at risk EG0026 affected14 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Gastrointestinal oedema	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Gingival erythema	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Gingival swelling	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Gingivitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected13 at risk EG0014 affected13 at risk EG0026 affected14 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0012 affected13 at risk EG0021 affected14 at risk EG003
Tongue discolouration	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Tongue ulceration	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Tooth socket haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0012 affected13 at risk EG0021 affected14 at risk EG003
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0011 affected13 at risk EG0022 affected14 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Catheter site inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Catheter thrombosis	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Chills	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG003
Cyst	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected13 at risk EG0014 affected13 at risk EG0022 affected14 at risk EG003
Gait disturbance	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Infusion site haemorrhage	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Injection site discomfort	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG003
Injection site erythema	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0012 affected13 at risk EG0023 affected14 at risk EG003
Injection site haematoma	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG003
Injection site haemorrhage	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0012 affected13 at risk EG0021 affected14 at risk EG003
Injection site irritation	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Injection site pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0012 affected13 at risk EG0024 affected14 at risk EG003
Injection site pruritus	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Injection site rash	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0012 affected13 at risk EG0020 affected14 at risk EG003
Injection site reaction	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0022 affected14 at risk EG003
Injection site swelling	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Malaise	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Mucosal inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected13 at risk EG0012 affected13 at risk EG0022 affected14 at risk EG003
Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0023 affected14 at risk EG003
Ulcer haemorrhage	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Bronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Candidiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Cystitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Furuncle	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Localised infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Oral herpes	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Parotitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pharyngeal abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0003 affected13 at risk EG0013 affected13 at risk EG0022 affected14 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Eye injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG003
Incision site pain	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Blood creatinine increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Blood pressure increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Cardiac murmur	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Heart sounds abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Platelet count decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pulmonary arterial pressure increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Reticulin increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Weight decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0012 affected13 at risk EG0021 affected14 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0013 affected13 at risk EG0025 affected14 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Iron overload	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0012 affected13 at risk EG0021 affected14 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0012 affected13 at risk EG0023 affected14 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Muscle swelling	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0012 affected13 at risk EG0025 affected14 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0012 affected13 at risk EG0024 affected14 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0012 affected13 at risk EG0021 affected14 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Lethargy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Mental impairment	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Migraine with aura	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Presyncope	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Tremor	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Depression	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0012 affected13 at risk EG0021 affected14 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0012 affected13 at risk EG0020 affected14 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Nervousness	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Penile discharge	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Perineal pain	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Scrotal erythema	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Scrotal swelling	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Vulvovaginal pain	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0014 affected13 at risk EG0021 affected14 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected13 at risk EG0014 affected13 at risk EG0021 affected14 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected13 at risk EG0013 affected13 at risk EG0021 affected14 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0012 affected13 at risk EG0020 affected14 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Postnasal drip	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG003
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0014 affected13 at risk EG0021 affected14 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0012 affected13 at risk EG0021 affected14 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0012 affected13 at risk EG0021 affected14 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0022 affected14 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected13 at risk EG0012 affected13 at risk EG0023 affected14 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Skin nodule	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Vasculitic rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected14 at risk EG003
Breast lump removal	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hot flush	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected14 at risk EG003
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0024 affected14 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected14 at risk EG003
Pallor	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected14 at risk EG003

ID	Term
D009190	Myelodysplastic Syndromes
D013921	Thrombocytopenia
D000095542	Cytopenia

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D001791	Blood Platelet Disorders

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides