Efficacy and Safety of Denosumab Compared With Risedronat... | NCT01575873

NCT01575873

ID	Type	Description	Link
2010-024393-19	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Denosumab	Experimental	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.	Drug: Denosumab Drug: Placebo for risendronate
Risendronate	Experimental	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.	Drug: Risendronate Drug: Placebo for denosumab

Name	Type	Description	Arm Group Labels	Other Names
Denosumab	Drug	Administered by subcutaneous injection once every 6 months	Denosumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)	Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).	Baseline and month 12

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)	Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).	Baseline and month 12
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29631782	Background	Saag KG, Wagman RB, Geusens P, Adachi JD, Messina OD, Emkey R, Chapurlat R, Wang A, Pannacciulli N, Lems WF. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):445-454. doi: 10.1016/S2213-8587(18)30075-5. Epub 2018 Apr 6.
30816640

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Risedronate: Glucocorticoid-initiating	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
FG001	Denosumab: Glucocorticoid-initiating

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Risedronate: Glucocorticoid-initiating	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
BG001	Denosumab: Glucocorticoid-initiating	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
BG002	Risedronate: Glucocorticoid-continuing	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
BG003	Denosumab: Glucocorticoid-continuing	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
BG004	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
	ParticipantsBG000145 ParticipantsBG001145 ParticipantsBG002252 ParticipantsBG003

Age, Customized

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000145 ParticipantsBG001145 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000145 ParticipantsBG001145 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000145 ParticipantsBG001145 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000145 ParticipantsBG001145 ParticipantsBG002

Menopausal Status

Females only

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00093 ParticipantsBG00193 ParticipantsBG002

Lumbar Spine Bone Mineral Density (BMD) T-score

The T-score is the bone mineral density (BMD) at the site when compared to that of a healthy thirty-year-old. Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5; Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a thirty-year-old man/woman.

Participants with observed values

Mean

Standard Deviation

T-score

Title	Denominators	Categories
Glucocorticoid-initiating Subpopulation	ParticipantsBG000143 ParticipantsBG001

Total Hip BMD T-score

participants with observed vaues

Mean

Standard Deviation

T-score

Title	Denominators	Categories
Glucocorticoid-initiating Subpopulation	ParticipantsBG000142 ParticipantsBG001

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

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)

Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

Randomized participants with a baseline and month 12 measurement for the lumbar spine BMD.

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline and month 12

ID	Title	Description
OG000	Risedronate: Glucocorticoid-initiating	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG001	Denosumab: Glucocorticoid-initiating	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
OG002	Risedronate: Glucocorticoid-continuing	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG003	Denosumab: Glucocorticoid-continuing	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.

Units	Counts
Participants	OG000126 OG001119 OG002211 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.8(0.2 to 1.5) OG0013.8(3.1 to 4.5) OG0022.3(1.7 to 2.9) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Analyses of the primary and secondary endpoints were performed independently within the glucocorticoid-continuing and glucocorticoid-initiating subpopulations. A fixed-sequence testing procedure was used to control the experiment-wise type 1 error rate at a two-sided 5% significance level within each subpopulation. The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD, sex, machine type, and baseline BMD-by-machine type interaction.	ANCOVA		< 0.001	One-sided p-value based on the prespecified noninferiority margin for lumbar spine of -1.1%.	LS Mean Difference	2.9			2-Sided	95	2.0	3.9			Least Squares (LS) Mean Difference = Denosumab - Risedronate

Secondary

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)

Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

Randomized participants with a baseline and month 12 measurement for the lumbar spine BMD.

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline and month 12

ID	Title	Description
OG000	Risedronate: Glucocorticoid-initiating	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG001	Denosumab: Glucocorticoid-initiating	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
OG002	Risedronate: Glucocorticoid-continuing	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG003

Secondary

Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12

Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).

Randomized participants with a baseline and month 12 measurement for the total hip BMD.

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline and month 12

ID	Title	Description
OG000	Risedronate: Glucocorticoid-initiating	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG001	Denosumab: Glucocorticoid-initiating	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
OG002	Risedronate: Glucocorticoid-continuing	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG003	Denosumab: Glucocorticoid-continuing

Secondary

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24

Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

Randomized participants with a baseline and month 24 measurement for the lumbar spine BMD.

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline and month 24

ID	Title	Description
OG000	Risedronate: Glucocorticoid-initiating	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG001	Denosumab: Glucocorticoid-initiating	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
OG002	Risedronate: Glucocorticoid-continuing	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG003	Denosumab: Glucocorticoid-continuing

Secondary

Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24

Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).

Randomized participants with a baseline and month 24 measurement for the total hip BMD.

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline and month 24

ID	Title	Description
OG000	Risedronate: Glucocorticoid-initiating	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG001	Denosumab: Glucocorticoid-initiating	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
OG002	Risedronate: Glucocorticoid-continuing	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
OG003	Denosumab: Glucocorticoid-continuing

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	Risedronate	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.	9	385	98	385	76	385
EG001	Denosumab	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.	13	394	92	394	77	394

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0011 affected394 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Aortic valve sclerosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0013 affected394 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0012 affected394 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0012 affected394 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Mitral valve disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0012 affected394 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Congenital megaureter	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0011 affected394 at risk
Glaucoma	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0011 affected394 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0012 affected394 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0012 affected394 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Subileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Death	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0012 affected394 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Eosinophilic granulomatosis with polyangiitis	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Food allergy	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Abdominal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Abscess limb	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Anal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Arthritis infective	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Clostridium colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0012 affected394 at risk
Erysipelas	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0012 affected394 at risk
Escherichia sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Haemorrhagic fever	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Lung abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Lymph node tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Lymphangitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Peritonitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0008 affected385 at risk EG0017 affected394 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Post procedural infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Serratia infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Wound infection bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0013 affected394 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0012 affected394 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Blood creatinine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Blood pressure increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
White blood cell count increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0012 affected394 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Ketosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Periarthritis calcarea	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected385 at risk EG0011 affected394 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Exposed bone in jaw	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0012 affected394 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Mixed connective tissue disease	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected385 at risk EG0012 affected394 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0011 affected394 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0012 affected394 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0012 affected394 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0012 affected394 at risk
Ataxia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0013 affected394 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Hemiparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Hydrocephalus	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Multiple sclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Paresis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Parkinson's disease	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Presyncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0012 affected394 at risk
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0013 affected394 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Behaviour disorder due to a general medical condition	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Delirium	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0012 affected394 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0011 affected394 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0011 affected394 at risk
Urinary retention	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Cervix haematoma uterine	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected385 at risk EG0011 affected394 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected385 at risk EG0010 affected394 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Cataract operation	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Colectomy	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Ileostomy	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0011 affected394 at risk
Lung neoplasm surgery	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Lymphadenectomy	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Sigmoidectomy	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Spinal decompression	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Aortic stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Capillary leak syndrome	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected385 at risk EG0010 affected394 at risk
Haemodynamic instability	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Temporal arteritis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected385 at risk EG0011 affected394 at risk
Thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0010 affected394 at risk
Vasculitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected385 at risk EG0012 affected394 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00019 affected385 at risk EG00120 affected394 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00033 affected385 at risk EG00123 affected394 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00021 affected385 at risk EG00124 affected394 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00015 affected385 at risk EG00121 affected394 at risk

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds