A Study to Evaluate the Long-term Safety, Tolerability an... | NCT01047319

NCT01047319

ID	Type	Description	Link
2009-015815-42	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
Experimental: 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.	Experimental: 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 7.13 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: >=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 Note that the change is compared to baseline,

Eligibility Module

Name	Affiliation	Role
Prof. Timothy Vollmer, MD	University of Colorado, Denver	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Teva Investigational Site 1267		Homewood	Alabama	35209	United States
Teva Investigational Site 1237

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Early Laquinimod	All participants in MS-LAQ-302E 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-302 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-302E 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-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
BG001	Switch From Placebo	All participants in MS-LAQ-302E 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-302 double-blind study who were administered placebo daily for 24 months.
BG002	Switch From Avonex	All participants in MS-LAQ-302E 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 Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
BG003	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
	BG00039.2± 9.16 BG00140.1± 9.23 BG00240.1± 9.34 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000228 BG001245 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian/Oriental	BG0001 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

Posted

Count of Participants

Participants

Day 1 up to 7.13 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-302E 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-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-302E 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-302 double-blind study who were administered placebo daily for 24 months.
OG002	Switch From Avonex	All participants in MS-LAQ-302E 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 Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.

Units	Counts
Participants	OG000345 OG001350 OG002352

Title

Denominators

Categories

=>1 TEAE

Title	Measurements
	OG000290 OG001303 OG002279

=>1 Serious TEAE

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: >=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

Note that the change is compared to baseline,

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

Posted

Count of Participants

Participants

Baseline (Day 0 for extension), Day 1 up to 7.13 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-302E 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-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-302E 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-302 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

Baseline (Day 0), Day 1 to 7.13 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-302E 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-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-302E 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-302 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

Baseline (Day 0), Day 1 to 7.13 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-302E 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-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-302E 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-302 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

Baseline (Day 0), Day 1 to 7.13 years

ID	Title	Description
OG000	Early Laquinimod	All participants in MS-LAQ-302E 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-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
OG001	Switch From Placebo	All participants in MS-LAQ-302E 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-302 double-blind study who were administered placebo daily for 24 months.
OG002	Switch From Avonex

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	All participants in MS-LAQ- 302E 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-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.	5	345	54	345	215	345
EG001	Switch From Placebo	All participants in MS-LAQ- 302E 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-302 double-blind study who were administered placebo daily for 24 months.	3	350	65	350	205	350
EG002	Switch From Avonex	All participants in MS-LAQ- 302E 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 Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.	5	352	51	352	194	352

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0010 events0 affected350 at risk EG0022 events2 affected352 at risk
Arrhythmia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Cardiac failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Left ventricular failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0023 events3 affected352 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Adrenal mass	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Goitre	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Blepharitis	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Cataract nuclear	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Iridocyclitis	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Ocular hypertension	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0022 events1 affected352 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Proctitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Allergy to metals	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Food allergy	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Acute hepatitis C	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Appendicitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Carbuncle	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Cellulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Chorioretinitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Cystitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Diverticulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Escherichia sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
HIV infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Herpes zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Incision site abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Lung abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Meningitis viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Orchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Papilloma viral infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Peritonitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Pilonidal cyst	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0022 events2 affected352 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected350 at risk EG0022 events2 affected352 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected350 at risk EG0022 events2 affected352 at risk
Pyelonephritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Salpingo-oophoritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Tuberculosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0022 events2 affected352 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected345 at risk EG0011 events1 affected350 at risk EG0022 events2 affected352 at risk
Viral pharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Epiphyseal fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0012 events2 affected350 at risk EG0020 events0 affected352 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0012 events2 affected350 at risk EG0020 events0 affected352 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Ureteric injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Hepatic enzyme increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Jaw cyst	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0012 events2 affected350 at risk EG0020 events0 affected352 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Cervix carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Malignant neoplasm of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0012 events2 affected350 at risk EG0020 events0 affected352 at risk
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0012 events2 affected350 at risk EG0020 events0 affected352 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0004 events3 affected345 at risk EG0014 events4 affected350 at risk EG0023 events3 affected352 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Brain oedema	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Epilepsy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0012 events1 affected350 at risk EG0021 events1 affected352 at risk
Hemiparesis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0012 events2 affected350 at risk EG0020 events0 affected352 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Muscle spasticity	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Radiculopathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Sciatica	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0012 events1 affected350 at risk EG0020 events0 affected352 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0013 events3 affected350 at risk EG0021 events1 affected352 at risk
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Device loosening	Product Issues	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Completed suicide	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Disorientation	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Panic attack	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Crush syndrome	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0014 events1 affected350 at risk EG0021 events1 affected352 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Bartholin's cyst	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0013 events3 affected350 at risk EG0020 events0 affected352 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Cervix disorder	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0015 events4 affected350 at risk EG0020 events0 affected352 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Menstrual disorder	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0012 events2 affected350 at risk EG0020 events0 affected352 at risk
Ovarian haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Pelvic adhesions	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Vaginal cyst	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0021 events1 affected352 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Bartholin's cyst removal	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Fracture reduction	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Hysterectomy	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Osteosynthesis	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Radical hysterectomy	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Skin lesion excision	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected350 at risk EG0020 events0 affected352 at risk
Splenectomy	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Aortic rupture	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Circulatory collapse	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0022 events2 affected352 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Internal haemorrhage	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected350 at risk EG0020 events0 affected352 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected350 at risk EG0021 events1 affected352 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	EG00034 events22 affected345 at risk EG00124 events20 affected350 at risk EG00218 events15 affected352 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00026 events24 affected345 at risk EG00129 events23 affected350 at risk EG00227 events16 affected352 at risk
Influenza	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00034 events27 affected345 at risk EG00138 events25 affected350 at risk EG00232 events22 affected352 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00096 events52 affected345 at risk EG00177 events46 affected350 at risk EG00258 events37 affected352 at risk
Pharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00018 events11 affected345 at risk EG00124 events18 affected350 at risk EG00215 events11 affected352 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00025 events20 affected345 at risk EG00124 events15 affected350 at risk EG00220 events16 affected352 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00062 events36 affected345 at risk EG00163 events36 affected350 at risk EG00259 events28 affected352 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00030 events22 affected345 at risk EG00122 events18 affected350 at risk EG00222 events17 affected352 at risk
C-reactive protein increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00025 events19 affected345 at risk EG00123 events17 affected350 at risk EG00216 events14 affected352 at risk
Weight increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00023 events19 affected345 at risk EG00111 events11 affected350 at risk EG00210 events9 affected352 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00027 events21 affected345 at risk EG00127 events23 affected350 at risk EG00238 events28 affected352 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00074 events49 affected345 at risk EG00172 events49 affected350 at risk EG00273 events50 affected352 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00084 events44 affected345 at risk EG001121 events60 affected350 at risk EG002128 events74 affected352 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00026 events26 affected345 at risk EG00121 events20 affected350 at risk EG00221 events17 affected352 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG00022 events18 affected345 at risk EG00123 events21 affected350 at risk EG00218 events18 affected352 at risk