Open Label Extension Study of Epratuzumab in Subjects Wit... | NCT01408576

ID	Type	Description	Link
2010-020859-30	EudraCT Number

Label	Type	Description	Intervention Names
Epratuzumab 600 mg per week	Experimental	600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Drug: Epratuzumab
Epratuzumab 1200 mg every other week	Experimental	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Drug: Epratuzumab

Name	Type	Description	Arm Group Labels	Other Names
Epratuzumab	Drug	600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles	Epratuzumab 600 mg per week

Measure	Description	Time Frame
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)	A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	During the treatment period (through Week 96)
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)	A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	During the treatment period (through Week 96)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)	A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: Death Life-threatening Significant or persistent disability/incapacity Congenital anomaly/birth defect (including that occurring in a fetus) Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious Initial inpatient hospitalization or prolongation of hospitalization	During the treatment period (through Week 96)
Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)	A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: Death Life-threatening Significant or persistent disability/incapacity Congenital anomaly/birth defect (including that occurring in a fetus) Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious Initial inpatient hospitalization or prolongation of hospitalization

Measure	Description	Time Frame
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index	Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

Name	Affiliation	Role
UCB Clinical Trial Call Center	UCB Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
539		Birmingham	Alabama		United States
557

ID	Title	Description
FG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)	Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
FG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)

A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received more than (>) 0mL of study medication.

Posted

Count of Participants

Participants

During the treatment period (through Week 96)

ID	Title	Description
OG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)	Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)	Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
OG002	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)	Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG003	All Epratuzumab 600 mg Per Week	600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG004	All Subjects	Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Units	Counts
Participants	OG000244 OG001497 OG002507 OG003

Title

Denominators

Categories

Title	Measurements
	OG00026 OG00145 OG00225 OG003

Primary

Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)

Posted

Number

percentage of participants

During the treatment period (through Week 96)

ID	Title	Description
OG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week	Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W	Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
OG002	Enrollment Cohort 2 Epratuzumab 600 mg Per Week

Primary

Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)

A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:

Death
Life-threatening
Significant or persistent disability/incapacity
Congenital anomaly/birth defect (including that occurring in a fetus)
Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
Initial inpatient hospitalization or prolongation of hospitalization

Posted

Count of Participants

Participants

During the treatment period (through Week 96)

ID	Title	Description
OG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week	Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W	Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Primary

Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)

A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:

Death
Life-threatening
Significant or persistent disability/incapacity
Congenital anomaly/birth defect (including that occurring in a fetus)
Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
Initial inpatient hospitalization or prolongation of hospitalization

Posted

Number

percentage of participants

During the treatment period (through Week 96)

ID	Title	Description
OG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week	Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W	Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Secondary

Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012.

Posted

Count of Participants

Participants

At Week 48

ID	Title	Description
OG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1)	Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012. Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1)	Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012. Subjects were enrolled prior to the approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Secondary

Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1)	Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012. Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1)	Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012. Subjects were enrolled prior to the approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Secondary

Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012, and with available results at the Week 96 time-point.

Posted

Count of Participants

Participants

Week 96

ID	Title	Description
OG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1)	Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012. Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1)

Secondary

The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1)	Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012. Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
OG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected497 at risk EG0022 events1 affected507 at risk EG0033 events2 affected751 at risk EG0045 events4 affected1,248 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0022 events2 affected507 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0021 events1 affected507 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0022 events2 affected507 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Splenic cyst	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Pericarditis	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Bradycardia	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Pleuropericarditis	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Sinoatrial block	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0022 events1 affected507 at risk EG003
Tachycardia	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Factor VII deficiency	Congenital, familial and genetic disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Toxic nodular goitre	Endocrine disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Cataract	Eye disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Amaurosis fugax	Eye disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Necrotising retinitis	Eye disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Panophthalmitis	Eye disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Retinal disorder	Eye disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events1 affected244 at risk EG0013 events3 affected497 at risk EG0023 events3 affected507 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected497 at risk EG0023 events3 affected507 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected497 at risk EG0021 events1 affected507 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0003 events2 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected497 at risk EG0021 events1 affected507 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0023 events1 affected507 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Eosinophilic colitis	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Oedematous pancreatitis	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0022 events1 affected507 at risk EG003
Oesophageal disorder	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Oesophageal motility disorder	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Chest pain	General disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0014 events4 affected497 at risk EG0029 events8 affected507 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Pyrexia	General disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected497 at risk EG0021 events1 affected507 at risk EG003
Asthenia	General disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Drug interaction	General disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Drug intolerance	General disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Hyperthermia	General disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Impaired healing	General disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Local swelling	General disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Oedema peripheral	General disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Serositis	General disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0023 events3 affected507 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0023 events2 affected507 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Cholelithiasis migration	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Pneumonia	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0006 events6 affected244 at risk EG0017 events7 affected497 at risk EG00210 events9 affected507 at risk EG003
Sepsis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0004 events3 affected244 at risk EG0013 events3 affected497 at risk EG0024 events4 affected507 at risk EG003
Cellulitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0014 events4 affected497 at risk EG0025 events3 affected507 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0013 events3 affected497 at risk EG0022 events2 affected507 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0013 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Diverticulitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Influenza	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0022 events2 affected507 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0023 events2 affected507 at risk EG003
Bronchitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Meningitis viral	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0022 events2 affected507 at risk EG003
Abscess	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Abscess limb	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Anal abscess	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Appendicitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Cystitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Cytomegalovirus chorioretinitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Endocarditis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Epstein-Barr virus infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Gangrene	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Haematoma infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Hepatitis B	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Herpes zoster	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Meningitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Meningitis aseptic	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Pelvic inflammatory disease	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Perineal abscess	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Salpingitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Tooth abscess	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0003 events3 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0023 events2 affected507 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Sternal fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Delayed recovery from anaesthesia	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Nail avulsion	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Biopsy liver	Investigations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Blood cortisol decreased	Investigations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Transaminases increased	Investigations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Troponin increased	Investigations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0022 events2 affected507 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0007 events7 affected244 at risk EG00115 events13 affected497 at risk EG00212 events12 affected507 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0014 events2 affected497 at risk EG0022 events2 affected507 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected497 at risk EG0021 events1 affected507 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0023 events3 affected507 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0022 events2 affected507 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Enthesopathy	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
SLE arthritis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0022 events2 affected507 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Myeloproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Headache	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0025 events4 affected507 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0003 events3 affected244 at risk EG0010 events0 affected497 at risk EG0023 events3 affected507 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0023 events3 affected507 at risk EG003
Migraine	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0022 events2 affected507 at risk EG003
Syncope	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected497 at risk EG0021 events1 affected507 at risk EG003
Convulsion	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0022 events1 affected507 at risk EG003
Dizziness	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0021 events1 affected507 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected497 at risk EG0020 events0 affected507 at risk EG003
Dysarthria	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Grand mal convulsion	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Monoparesis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0022 events1 affected507 at risk EG003
Altered state of consciousness	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Cerebrovascular disorder	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Epilepsy	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Lupus encephalitis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Memory impairment	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Motor dysfunction	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Neuropsychiatric lupus	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Optic neuritis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Radiculitis brachial	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Seizure anoxic	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Sinus headache	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Thecal sac compression	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Thoracic outlet syndrome	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Transverse sinus thrombosis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
VIIth nerve paralysis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA17.0	Non-systematic Assessment	EG0003 events3 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Foetal death	Pregnancy, puerperium and perinatal conditions	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Premature delivery	Pregnancy, puerperium and perinatal conditions	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Depression	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0022 events2 affected507 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0022 events2 affected507 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Lupus nephritis	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0013 events3 affected497 at risk EG0021 events1 affected507 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0022 events2 affected507 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0023 events2 affected507 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Glomerulonephritis	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Glomerulonephritis membranoproliferative	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Kidney fibrosis	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0022 events2 affected507 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Adenomyosis	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Vaginal prolapse	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected497 at risk EG0021 events1 affected507 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0022 events2 affected507 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0021 events1 affected507 at risk EG003
Cutaneous vasculitis	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Chronic cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Abortion induced	Surgical and medical procedures	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Cholecystectomy	Surgical and medical procedures	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Joint arthroplasty	Surgical and medical procedures	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Polymedication	Surgical and medical procedures	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Shoulder operation	Surgical and medical procedures	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected497 at risk EG0020 events0 affected507 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0003 events3 affected244 at risk EG0010 events0 affected497 at risk EG0022 events2 affected507 at risk EG003
Hypertension	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected497 at risk EG0020 events0 affected507 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected497 at risk EG0020 events0 affected507 at risk EG003
Arterial occlusive disease	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003
Temporal arteritis	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected497 at risk EG0020 events0 affected507 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected497 at risk EG0021 events1 affected507 at risk EG003

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

ID	Title	Description
BG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)	Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
BG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)	Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
BG002	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)	Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
BG003	Total Title

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Enrollment Cohort 1 Epratuzumab 600 mg Per Week	Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	4	244	81	244	177	244
EG001	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W	Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	4	497	119	497	296	497
EG002	Enrollment Cohort 2 Epratuzumab 600 mg Per Week	Subjects enrolled after approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	1	507	104	507	306	507
EG003	All Epratuzumab 600 mg Per Week	600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	5	751	185	751	483	751
EG004	All Subjects	Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	9	1,248	304	1,248	779	1,248