Evaluation of Sarilumab (SAR153191/REGN88) on Top of Meth... | NCT01061736

NCT01061736

ID	Type	Description	Link
2009-016266-90	EudraCT Number

Status Module

Sponsor/Collaborators Module

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Oversight Module

Description Module

Conditions 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
Part A: SAR 100 mg qw	Experimental	Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of MTX for 12 weeks.	Drug: Sarilumab Drug: Methotrexate Drug: Folic Acid
Part A: SAR 150 mg qw	Experimental	Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.	Drug: Sarilumab Drug: Methotrexate Drug: Folic Acid
Part A: SAR 100 mg q2w	Experimental	Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.	Drug: Sarilumab Drug: Placebo (for sarilumab) Drug: Methotrexate Drug: Folic Acid
Part A: SAR 150 mg q2w	Experimental	Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.	Drug: Sarilumab Drug: Placebo (for sarilumab) Drug: Methotrexate Drug: Folic Acid
Part A: SAR 200 mg q2w	Experimental	Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sarilumab	Drug	Pharmaceutical form: solution for injection Route of administration: subcutaneous	Part A: SAR 100 mg q2w Part A: SAR 100 mg qw Part A: SAR 150 mg q2w

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12	ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).	Baseline to Week 12
Part B: Percentage of Participants Achieving ACR20 Response at Week 24	ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.	Baseline to Week 24
Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16	HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.	Baseline, Week 16
Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52	The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.

Secondary Outcomes

Measure	Description	Time Frame
Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52	Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Mark C Genovese, MD, Professor of Medicine	Division of Immunology and Rheumatology - Stanford University - USA	Principal Investigator
TWJ Huizinga, Prof Dr	Dpt of Rheumatology - Leiden University Medical Center - The Netherlands	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 840070		Anniston	Alabama	36207	United States
Investigational Site Number 840004

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27600829	Background	Strand V, Kosinski M, Chen CI, Joseph G, Rendas-Baum R, Graham NM, van Hoogstraten H, Bayliss M, Fan C, Huizinga T, Genovese MC. Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial. Arthritis Res Ther. 2016 Sep 6;18(1):198. doi: 10.1186/s13075-016-1096-9.
24297381

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: SAR 100 mg qw	Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of methotrexate (MTX) for 12 weeks.
FG001	Part A: SAR 150 mg qw	Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Drug: Sarilumab
Drug: Placebo (for sarilumab)
Drug: Methotrexate
Drug: Folic Acid

Part A: SAR 150 mg qw

Part A: SAR 200 mg q2w

Part B Cohort 1: Non-selected Doses

Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)

Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Part A: SAR 100 mg qw	Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
BG001	Part A: SAR 150 mg qw	Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
BG002	Part A: SAR 100 mg q2w	Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
BG003	Part A: SAR 150 mg q2w	Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
BG004	Part A: SAR 200 mg q2w	Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
BG005	Part A: Placebo qw	Placebo (for sarilumab) qw on top of MTX for 12 weeks.
BG006	Part B Cohort 1: Non-selected Doses	Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
BG007	Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)	Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
BG008	Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)	Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
BG009	Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)	Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
BG010	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00062 OG00172 OG00249 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 OG005	Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. The multiplicity issues were addressed by using the Hommel-procedure.	Cochran-Mantel-Haenszel		0.1155	Threshold for significance = 0.05.	Odds Ratio (OR)	1.99			2-Sided	95	0.85	4.64					Superiority or Other

Primary

Part B: Percentage of Participants Achieving ACR20 Response at Week 24

ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.

ITT population which included all participants randomized after dose selection (cohort 2).

Posted

Number

Percentage of participants

Baseline to Week 24

ID	Title	Description
OG000	Part B: SAR 150 mg q2w	Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
OG001	Part B: SAR 200 mg q2w	Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
OG002	Part B: Placebo q2w	Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks

Primary

Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16

HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.

Cohort 2 ITT population only and included participants with available data of HAQ-DI at baseline and on or before Week 16.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 16

ID	Title	Description
OG000	Part B: SAR 150 mg q2w	Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
OG001	Part B: SAR 200 mg q2w	Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
OG002	Part B: Placebo q2w	Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.

Primary

Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52

The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.

Cohort 2 ITT population and included participants with available data of mTSS at baseline and on or before Week 52.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 52

ID	Title	Description
OG000	Part B: SAR 150 mg q2w	Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
OG001	Part B: SAR 200 mg q2w	Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
OG002	Part B: Placebo q2w	Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.

Secondary

Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52

Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.

ITT population which included all participants randomized after dose selection (cohort 2).

Posted

Number

Percentage of participants

Baseline up to Week 52

ID	Title	Description
OG000	Part B: SAR 150 mg q2w	Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
OG001	Part B: SAR 200 mg q2w	Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
OG002	Part B: Placebo q2w	Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: SAR 100 mg qw	Part A participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).	3	50	16	50
EG001	Part A: SAR 150 mg qw	Part A participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks).	0	50	16	50
EG002	Part A: SAR 100 mg q2w	Part A participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 11 weeks).	3	51	7	51
EG003	Part A: SAR 150 mg q2w	Part A participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 12 weeks). Included the participant randomized to placebo qw who received sarilumab 150 mg q2w in error.	0	52	12	52
EG004	Part A: SAR 200 mg q2w	Part A participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 11 weeks).	0	51	19	51
EG005	Part A: Placebo qw	Part A participants exposed to placebo on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received an erroneous IMP kit with sarilumab 150 mg q2w. He/she was considered in the 150 mg q2w treatment group for safety analysis.	2	51	11	51
EG006	Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose)	Part B participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).	2	29	6	29
EG007	Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)	Part B participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received sarilumab 100 mg q2w in error. He/she was considered in the 100 mg q2w treatment group for safety analysis.	2	26	8	26
EG008	Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)	Part B participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 13 weeks). Included 1 participant who received sarilumab 100 mg q2w in error.	0	29	6	29
EG009	Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)	Part B participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 42 weeks). 61 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Included 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error.	35	370	163	370
EG010	Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)	Part B participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 42 weeks). 55 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error and included a participant randomized to placebo q2w who received sarilumab 200 mg q2w in error.	46	369	194	369
EG011	Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)	Part B participants exposed to placebo q2w on top of MTX (mean exposure of 40 weeks). 168 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 1 participant randomized to placebo q2w who received sarilumab 200 mg q2w in error. He/she was considered in the 200 mg q2w treatment group for safety analysis.	21	259	95	259
EG012	Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2	Part B participants exposed to sarilumab 150 mg q2w or 200 mg q2w or placebo q2w, without adequate response from Week 16, rescued with high dose of sarilumab (SAR 200 mg q2w) (mean exposure of 49 weeks from beginning of randomization to the end of rescue treatment).	7	284	83	284

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG0030 affected52 at risk EG004
Leukopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Splenic vein thrombosis	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cardiovascular insufficiency	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Myocardial ischemia	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Abdominal wall hematoma	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Duodenal ulcer hemorrhage	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Gastric hemorrhage	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Gastric ulcer hemorrhage	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hemorrhoids	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Immediate post-injection reaction	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Impaired healing	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hepatitis toxic	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Abscess limb	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Abscess oral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Appendicitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Bronchitis fungal	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cellulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Endometritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Erysipelas	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Incision site infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Otitis media chronic	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pyelonephritis chronic	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Septic shock	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Sinusitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Subacute endocarditis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Tinea cruris	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Wound hemorrhage	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Transaminases increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hypercalcemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Neoplasm of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Brain oedema	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Embolic cerebral infarction	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Ischemic stroke	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Transient ischemic attack	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Depression	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Aortic thrombosis	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Embolism arterial	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Shock hemorrhagic	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected50 at risk EG0015 affected50 at risk EG0020 affected51 at risk EG0031 affected52 at risk EG00410 affected51 at risk EG0050 affected51 at risk EG0061 affected29 at risk EG0072 affected26 at risk EG0081 affected29 at risk EG00936 affected370 at risk EG01055 affected369 at risk EG0110 affected259 at risk EG0125 affected284 at risk
Injection site erythema	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected50 at risk EG0011 affected50 at risk EG0021 affected51 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected50 at risk EG0012 affected50 at risk EG0020 affected51 at risk EG003
Influenza	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 affected50 at risk EG0011 affected50 at risk EG0022 affected51 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected50 at risk EG0012 affected50 at risk EG0020 affected51 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0003 affected50 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0002 affected50 at risk EG0013 affected50 at risk EG0021 affected51 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0002 affected50 at risk EG0012 affected50 at risk EG0020 affected51 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0013 affected50 at risk EG0021 affected51 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0022 affected51 at risk EG003

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C000592401	sarilumab
D008727	Methotrexate
D005492	Folic Acid

Units	Counts
Participants	OG000400 OG001399 OG002398

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0091 affected370 at risk

EG0100 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0101 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0061 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0093 affected370 at risk

EG0104 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0091 affected370 at risk

EG0100 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0091 affected370 at risk

EG0101 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0101 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0100 affected369 at risk

EG0111 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0101 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0101 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0100 affected369 at risk

EG0111 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0100 affected369 at risk

EG0111 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0091 affected370 at risk

EG0100 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0100 affected369 at risk

EG0110 affected259 at risk

EG0121 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0100 affected369 at risk

EG0111 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0101 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

EG0050 affected51 at risk

EG0060 affected29 at risk

EG0070 affected26 at risk

EG0080 affected29 at risk

EG0090 affected370 at risk

EG0101 affected369 at risk

EG0110 affected259 at risk

EG0120 affected284 at risk

EG0040 affected51 at risk

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds