An Open-label Study to Evaluate the Long-term Safety of M... | NCT01753193

ID	Type	Description	Link
2012-004619-30	EudraCT Number

Label	Type	Description	Intervention Names
Anifrolumab	Experimental	Participants will receive IV infusion of anifrolumab 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter will receive 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.	Biological: Anifrolumab

Name	Type	Description	Arm Group Labels	Other Names
Anifrolumab	Biological	Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Measure	Description	Time Frame
Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. 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.	From first dose of study drug (Day 1) through 168 weeks
Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab	Number of participants with DAEs are reported.	From first dose of study drug (Day 1) through 168 weeks
Number of Participants With Adverse Events of Special Interest (AESIs)	An AESI is scientific and medical concern specific to understanding of the study drug. An AESI may be serious or non-serious. Number of participants with AESIs are reported.	From first dose of study drug (Day 1) through 168 weeks

Measure	Description	Time Frame
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab	The number of participants with positive serum antibodies to anifrolumab at anytime (including baseline) are reported.	Baseline (Pre-dose on Day 1) up to Week 168
Anti-Drug Antibodies (ADA) Titer to Anifrolumab

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35294	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
33225631	Derived	Chatham WW, Furie R, Saxena A, Brohawn P, Schwetje E, Abreu G, Tummala R. Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. Arthritis Rheumatol. 2021 May;73(5):816-825. doi: 10.1002/art.41598. Epub 2021 Mar 24.

ID	Title	Description
FG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 12, 2015	Jul 11, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. 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.

As-treated population included all participants who received any dose of study drug in the OLE study.

Posted

Count of Participants

Participants

From first dose of study drug (Day 1) through 168 weeks

ID	Title	Description
OG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Units	Counts
Participants	OG000218

Title

Denominators

Categories

TEAEs

Title	Measurements
	OG000170

TESAEs

Title	Measurements
	OG00050

Primary

Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab

Number of participants with DAEs are reported.

As-treated population included all participants who received any dose of study drug in the OLE study.

Posted

Count of Participants

Participants

From first dose of study drug (Day 1) through 168 weeks

ID	Title	Description
OG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab

The number of participants with positive serum antibodies to anifrolumab at anytime (including baseline) are reported.

As-treated population included all participants who received any dose of study drug in the OLE study. Participants with reportable ADA titer results were analyzed for this outcome measure.

Posted

Count of Participants

Participants

Baseline (Pre-dose on Day 1) up to Week 168

ID	Title	Description
OG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Units	Counts
Participants	OG000

Secondary

Anti-Drug Antibodies (ADA) Titer to Anifrolumab

Median ADA titer in participants with ADA-positive assessments and reportable ADA titer results are reported.

As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.

Posted

Median

Full Range

Antibody titers

Baseline (Pre-dose on Day 1) up to Week 168

ID	Title	Description
OG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Units	Counts
Participants	OG000

Secondary

Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab

Number of participants with decreased serum concentration of anifrolumab due to ADA-positive results are reported.

Posted

Count of Participants

Participants

Baseline (Pre-dose on Day 1) up to Week 168

ID	Title	Description
OG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Units	Counts
Participants	OG000

Secondary

Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab

Number of participants with decreased pharmacodynamic response of anifrolumab due to ADA-positive results are reported.

Posted

Count of Participants

Participants

Baseline (Pre-dose on Day 1) up to Week 168

ID	Title	Description
OG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Units	Counts
Participants	OG000

Secondary

Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants

The SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).

Posted

Mean

Standard Deviation

Units on Score

Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168

ID	Title	Description
OG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Units	Counts
Participants

Secondary

Number of ADA-positive Participants With TEAEs and TESAEs

The number of ADA-positive participants with TEAEs and TESAEs are reported.

Posted

Count of Participants

Participants

Baseline (Pre-dose on Day 1) up to Week 168

ID	Title	Description
OG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Units	Counts
Participants	OG000

Primary

Number of Participants With Adverse Events of Special Interest (AESIs)

An AESI is scientific and medical concern specific to understanding of the study drug. An AESI may be serious or non-serious. Number of participants with AESIs are reported.

As-treated population included all participants who received any dose of study drug in the OLE study.

Posted

Count of Participants

Participants

From first dose of study drug (Day 1) through 168 weeks

ID	Title	Description
OG000	Anifrolumab	Participants received intravenous (IV) infusion of anifrolumab (MEDI-546) 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter received 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected218 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pericarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hypothalamic pituitary adrenal axis suppression	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Cyst	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Mucosal inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Abscess limb	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Chikungunya virus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Dengue fever	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Latent tuberculosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Mastoiditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected218 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Post procedural infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Tooth abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected218 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected218 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected218 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Epilepsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Idiopathic intracranial hypertension	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected218 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
High risk pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Renal impairment	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected218 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected218 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hyperleukocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Leukaemoid reaction	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events2 affected218 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Neutrophilia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected218 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Bifascicular block	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Bundle branch block right	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Left atrial dilatation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Thyroid mass	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Blepharitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Blepharochalasis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected218 at risk
Chalazion	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Eyelid oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Macular degeneration	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Myopia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Scleritis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Vision blurred	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Visual acuity reduced	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected218 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected218 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected218 at risk
Dental caries	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00012 events11 affected218 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Enteritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Gastric mucosa erythema	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected218 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Internal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected218 at risk
Noninfective gingivitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Toothache	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Acquired gene mutation	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected218 at risk
Cyst	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Influenza like illness	General disorders	MedDRA 21.0	Systematic Assessment	EG00010 events6 affected218 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected218 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected218 at risk
Tenderness	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected218 at risk
Hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Seasonal allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Acarodermatitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Acute sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Appendicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Body tinea	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Bone abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00033 events28 affected218 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Bronchitis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Candida infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events3 affected218 at risk
Cervicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Dermatophytosis of nail	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Ear infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Furuncle	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected218 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected218 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected218 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Genital candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Genital herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected218 at risk
Infected bite	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected218 at risk
Latent tuberculosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected218 at risk
Lymphangitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Nail infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00040 events32 affected218 at risk
Onychomycosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected218 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected218 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected218 at risk
Papilloma viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Paronychia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Parotitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected218 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Pleurisy viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected218 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pulpitis dental	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00012 events8 affected218 at risk
Skin candida	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Skin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Streptococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected218 at risk
Tinea manuum	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Tonsillitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Tracheobronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00029 events20 affected218 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00017 events13 affected218 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Vaginal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected218 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected218 at risk
Vulval abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Vulvovaginitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Zika virus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected218 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0009 events4 affected218 at risk
Injection related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected218 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Scar	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Blood immunoglobulin a decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Blood potassium decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Electrocardiogram qt shortened	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hepatic enzyme increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Lipids abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Liver function test increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Mycobacterium tuberculosis complex test positive	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Neutrophil count increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected218 at risk
Nuclear magnetic resonance imaging brain abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Transaminases increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Weight increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Acquired mixed hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected218 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected218 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected218 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected218 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Myofascial pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected218 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected218 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected218 at risk
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Vulvovaginal warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected218 at risk
Encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00021 events14 affected218 at risk
Hypersomnia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Lumbosacral radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Migraine	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected218 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pineal gland cyst	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected218 at risk
Visual field defect	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Depressed mood	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected218 at risk
Libido decreased	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Dysuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Nephritis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Breast discharge	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected218 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Dyspareunia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Endometrial thickening	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Menstruation delayed	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Polymenorrhoea	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Uterine cervical erosion	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Catarrh	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected218 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected218 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Idiopathic urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Keratosis pilaris	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Mechanical urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected218 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected218 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected218 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected218 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected218 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected218 at risk
Peripheral coldness	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected218 at risk
Peripheral venous disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Phlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk
Vasculitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected218 at risk

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases