A Study To Evaluate the Long-Term Safety, Tolerability an... | NCT00988052

NCT00988052

ID	Type	Description	Link
2009-012989-30	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Laquinimod	Experimental	One capsule containing 0.6 mg laquinimod to be administered orally once daily.	Drug: Laquinimod

Name	Type	Description	Arm Group Labels	Other Names
Laquinimod	Drug	One capsule containing 0.6 mg laquinimod to be administered orally once daily.	Laquinimod

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants With Treatment-Emergent Adverse Events (TEAEs)	A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.	Day 1 up to 7.64 years

Secondary Outcomes

Measure	Description	Time Frame
Participants With Potentially Clinically Significant Abnormal Vital Signs	Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria: Pulse rate low: <=45 and decrease >=30 beats/minute Pulse rate high: >=120 and increase >=30 beats/minute Systolic blood pressure low: <=90 and decrease >=30 mmHg Systolic blood pressure high: >=180 and increase >=30 mmHg Diastolic blood pressure low: <=50 and decrease >=20 mmHg Diastolic blood pressure high: >=100 and increase >=20 mmHg

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Giancarlo Comi, Prof., MD	U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Teva Investigational Site 1076		Phoenix	Arizona	85004	United States
Teva Investigational Site 1090

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Early Laquinimod	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 25, 2016

Arm/Group Information

ID	Title	Description
BG000	Early Laquinimod	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
BG001	Switch From Placebo	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00041.1± 9.10 BG00140.5± 9.14 BG00240.8± 9.12

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000298 BG001271 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian / Oriental	BG0002 BG0010 BG002

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

Participants With Treatment-Emergent Adverse Events (TEAEs)

A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.

Safety analysis set

Posted

Count of Participants

Participants

Day 1 up to 7.64 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Units	Counts
Participants	OG000423 OG001416

Title

Denominators

Categories

=>1 TEAE

Title	Measurements
	OG000375 OG001374

=>1 Severe TEAE

Title	Measurements
	OG000

Secondary

Participants With Potentially Clinically Significant Abnormal Vital Signs

Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria:

Pulse rate low: <=45 and decrease >=30 beats/minute
Pulse rate high: >=120 and increase >=30 beats/minute
Systolic blood pressure low: <=90 and decrease >=30 mmHg
Systolic blood pressure high: >=180 and increase >=30 mmHg
Diastolic blood pressure low: <=50 and decrease >=20 mmHg
Diastolic blood pressure high: >=100 and increase >=20 mmHg

Safety analysis set of participants with a baseline and post-baseline value for that vital sign.

Posted

Count of Participants

Participants

Day 1 up to 7.64 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Secondary

Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study

Counts include two conditions:

a change from High / Non-PCS at baseline to Low PCS at any point during the study
a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non- PCS value are included in the population count. ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassium

Safety analysis set of participants with both a baseline and a post-baseline value for the test.

Posted

Count of Participants

Participants

Day 1 up to 7.64 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Secondary

Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study

Counts include two conditions:

a change from High / Non-PCS at baseline to Low PCS at any point during the study
a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non- PCS value are included in the population count.

Safety analysis set of participants with both a baseline and a post-baseline value for the test.

Posted

Count of Participants

Participants

Day 1 up to 7.64 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Secondary

Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study

Shifts are presented as Baseline finding / Worse finding at anytime during the study.

Categories for findings are:

normal
abnormal, not clinically significant (Not CS)
abnormal, clinically significant (CS)

Safety analysis set of participants with both a baseline and a post-baseline ECG.

Posted

Count of Participants

Participants

Day 1 up to 7.64 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Early Laquinimod 0.6 mg	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.	3	423	108	423	299	423
EG001	Switch From Placebo to Laquinimod 0.6 mg	All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months.	3	416	92	416	300	416

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Bone marrow oedema	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Angina pectoris	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Angina unstable	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0012 events2 affected416 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0010 events0 affected416 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Myocardial infarction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0012 events2 affected416 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Pericarditis	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Deafness	Ear and labyrinth disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Goitre	Endocrine disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Parathyroid gland enlargement	Endocrine disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Blindness unilateral	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Eye haemorrhage	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Uveitis	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Gastritis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events2 affected416 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0010 events0 affected416 at risk
Ileus	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Omental infarction	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Volvulus	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Asthenia	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Chest discomfort	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Chest pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0010 events0 affected416 at risk
Death	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Drowning	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Fatigue	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Gait disturbance	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Impaired healing	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Inflammation	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Influenza like illness	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Medical device pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Non-cardiac chest pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events1 affected416 at risk
Pyrexia	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0011 events1 affected416 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Abdominal abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Abscess limb	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Acute sinusitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Appendicitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0004 events4 affected423 at risk EG0013 events3 affected416 at risk
Appendicitis perforated	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0011 events1 affected416 at risk
Bartholin's abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected423 at risk EG0010 events0 affected416 at risk
Breast abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected423 at risk EG0010 events0 affected416 at risk
Cellulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Cholecystitis infective	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Chronic tonsillitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Diverticulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Furuncle	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Groin abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0010 events0 affected416 at risk
Hepatic echinococciasis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events1 affected416 at risk
Influenza	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Latent syphilis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Latent tuberculosis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Meningitis viral	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events1 affected416 at risk
Mycotoxicosis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Nasopharyngitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Otitis media chronic	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Ovarian abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Peritonitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0004 events4 affected423 at risk EG0010 events0 affected416 at risk
Periumbilical abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Pertussis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Pharyngeal abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Pilonidal cyst	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Pneumonia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0014 events3 affected416 at risk
Postoperative wound infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Pyelonephritis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Salpingo-oophoritis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Staphylococcal infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Tonsillitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Tubo-ovarian abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0011 events1 affected416 at risk
Urosepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Vestibular neuronitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events1 affected416 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected423 at risk EG0010 events0 affected416 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0010 events0 affected416 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events2 affected416 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
C-reactive protein increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0004 events4 affected423 at risk EG0011 events1 affected416 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Hepatic enzyme increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected423 at risk EG0010 events0 affected416 at risk
Obesity	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events2 affected423 at risk EG0013 events3 affected416 at risk
Intervertebral disc space narrowing	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Joint hyperextension	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected423 at risk EG0010 events0 affected416 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0010 events0 affected416 at risk
Knee impingement syndrome	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events2 affected416 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected423 at risk EG0011 events1 affected416 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events1 affected423 at risk EG0010 events0 affected416 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Tendon calcification	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0011 events1 affected416 at risk
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Chronic lymphocytic leukaemia stage 1	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Langerhans' cell histiocytosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected423 at risk EG0010 events0 affected416 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected423 at risk EG0010 events0 affected416 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Oncocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Tubular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected423 at risk EG0014 events4 affected416 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events1 affected416 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Cerebral artery occlusion	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Epilepsy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected423 at risk EG0010 events0 affected416 at risk
Headache	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Lethargy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected423 at risk EG0012 events2 affected416 at risk
Optic neuritis	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Paraesthesia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Sciatica	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Simple partial seizures	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Syncope	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected423 at risk EG0011 events1 affected416 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0013 events3 affected416 at risk
Agoraphobia	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Anxiety	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Completed suicide	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Depression	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events2 affected416 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Neurosis	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Panic disorder	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Suicide attempt	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Bladder dysfunction	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Haematuria	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events2 affected416 at risk
Ketonuria	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0011 events1 affected416 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Urethral meatus stenosis	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected423 at risk EG0012 events2 affected416 at risk
Fibrocystic breast disease	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Hydrosalpinx	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events1 affected416 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events1 affected416 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events2 affected423 at risk EG0010 events0 affected416 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected423 at risk EG0010 events0 affected416 at risk
Pharyngeal polyp	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0011 events1 affected416 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Hysterectomy	Surgical and medical procedures	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Intervertebral disc operation	Surgical and medical procedures	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Nephrectomy	Surgical and medical procedures	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Spinal fusion surgery	Surgical and medical procedures	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected423 at risk EG0010 events0 affected416 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Hypertension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Hypertensive crisis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0012 events2 affected416 at risk
Hypotension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected423 at risk EG0011 events1 affected416 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG00025 events22 affected423 at risk EG00117 events16 affected416 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00023 events19 affected423 at risk EG00139 events31 affected416 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00031 events24 affected423 at risk EG00123 events21 affected416 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00027 events24 affected423 at risk EG00137 events26 affected416 at risk
Fatigue	General disorders	MedDRA (19.0)	Systematic Assessment	EG00030 events25 affected423 at risk EG00138 events31 affected416 at risk
Bronchitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00044 events33 affected423 at risk EG00146 events33 affected416 at risk
Influenza	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00041 events28 affected423 at risk EG00146 events34 affected416 at risk
Nasopharyngitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG000169 events106 affected423 at risk EG001210 events112 affected416 at risk
Sinusitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00036 events27 affected423 at risk EG00147 events28 affected416 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00069 events43 affected423 at risk EG00165 events41 affected416 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG000110 events55 affected423 at risk EG00176 events39 affected416 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG00030 events20 affected423 at risk EG00130 events23 affected416 at risk
Alanine aminotransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00016 events13 affected423 at risk EG00127 events22 affected416 at risk
C-reactive protein increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00031 events26 affected423 at risk EG00137 events31 affected416 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00027 events22 affected423 at risk EG00123 events16 affected416 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00057 events41 affected423 at risk EG00159 events47 affected416 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG000127 events78 affected423 at risk EG001124 events77 affected416 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00015 events11 affected423 at risk EG00129 events25 affected416 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00035 events28 affected423 at risk EG00145 events33 affected416 at risk
Headache	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG000132 events57 affected423 at risk EG001160 events86 affected416 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG00035 events17 affected423 at risk EG00136 events29 affected416 at risk
Depression	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG00041 events35 affected423 at risk EG00135 events28 affected416 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG00026 events24 affected423 at risk EG00140 events35 affected416 at risk
Hypertension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG00032 events32 affected423 at risk EG00126 events26 affected416 at risk