Study To Evaluate The Safety And Efficacy Of ILV-094 In S... | NCT00883896

ID	Type	Description	Link
B1981001	Other Identifier	Alias Study Number
2008-006936-37	EudraCT Number

Label	Type	Description	Intervention Names
Arm 1	Placebo Comparator	Part 1: Placebo	Other: Placebo
Arm 2	Experimental	Part 1: 100 mg ILV-094 SC Q4W	Drug: ILV-094
Arm 3	Experimental	Part 1: 100 mg ILV-094 SC Q2W	Drug: ILV-094
Arm 4	Placebo Comparator		Other: Placebo
Arm 5	Experimental	Part 2: 200 mg ILV-094 SC Q2W	Drug: ILV-094

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Part 1: Placebo SC administration every 2 weeks X 10 weeks.	Arm 1

Measure	Description	Time Frame
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12	ACR20 response: greater than or equal to (>=) 20 percent improvement in tender joint count; >=20 percent improvement in swollen joint count; and >=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).	Week 12

Measure	Description	Time Frame
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10	ACR20 response: >=20 percent improvement in tender joint count; >=20 percent improvement in swollen joint count; and >=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Arthritis & Rheumatology Research, PLLC		Glendale	Arizona	85304	United States
Desert Medical Advances

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
FG001	ILV-094 100 mg Every 4 Weeks

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

Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12

ACR20 response: greater than or equal to (>=) 20 percent improvement in tender joint count; >=20 percent improvement in swollen joint count; and >=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).

mITT population included all randomized participants who received at least 1 dose of study drug. Last observation carried forward (LOCF) method was used to impute missing values.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG002	ILV-094 100 mg Every 2 Weeks	Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG003	ILV-094 200 mg Every 2 Weeks	Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Units	Counts
Participants	OG00066 OG00139 OG00242 OG003

Title

Denominators

Categories

Title	Measurements
	OG00050.0(37.4 to 62.6) OG00143.6(27.8 to 60.4) OG00238.1(23.6 to 54.4) 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	P-value was assessed from 2-sided Cochran-Mantel-Haenszel (CMH) test stratified by anti-tumor necrosis factor (anti-TNF) prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.	Cochran-Mantel-Haenszel		0.558		Percent Difference	-5.9			2-Sided	95	-25.0	13.3					Superiority or Other (legacy)

Secondary

Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10

ACR20 response: >=20 percent improvement in tender joint count; >=20 percent improvement in swollen joint count; and >=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 2, 4, 6, 8, 10

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12

ACR50 response: >=50 percent improvement in tender joint count; >=50 percent improvement in swollen joint count; and 50 improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12

ACR70 response:>=70 percent improvement in tender joint count; >=70 percent improvement in swollen joint count; and 70 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP)

DAS28 (CRP) was calculated from number of swollen joints and tender joints using the 28 joints count; CRP (milligram/Liter [mg/L]); and general health visual analog scale (VAS) score (participant rated scale with scores ranging from 0mm [very well] to 100mm [extremely bad]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (CRP) less than or equal to (<=) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 implied remission.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR)

DAS28 (ESR) was calculated from the number of swollen joints and tender joints using the 28 joints count; ESR (millimeters per hour [mm/hour]); and general health VAS score (participant rated scale with scores ranging from 0 [very well] to 100 [extremely bad]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6 implied remission.

mITT population included all randomized participants who received at least 1 or even partial dose of study drug. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

Tender Joints Counts (TJC)

Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Mean

Standard Deviation

Tender joints

Baseline, Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG002	ILV-094 100 mg Every 2 Weeks	Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG003

Secondary

Swollen Joints Count (SJC)

Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Mean

Standard Deviation

Swollen joints

Baseline, Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG002	ILV-094 100 mg Every 2 Weeks	Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG003

Secondary

Physician Global Assessment of Disease Activity

Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG002	ILV-094 100 mg Every 2 Weeks	Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

Participant Global Assessment of Disease Activity

Participants answered: "considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a scale ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG002	ILV-094 100 mg Every 2 Weeks	Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

Pain Visual Analog Scale (VAS)

Participants assessed the amount of pain currently experienced by them on a 100 millimeter (mm) VAS ranging from 0= no pain to 100= severe pain.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Mean

Standard Deviation

Millimeter

Baseline, Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG002	ILV-094 100 mg Every 2 Weeks	Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

General Health Visual Analog Scale (VAS)

General health VAS is a 100 mm line marked by the participant. Participants were asked, "In general how would you rate your health currently concerning the arthritis?" Scores ranged from 0 mm = very well to 100 mm = extremely bad.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Posted

Mean

Standard Deviation

Millimeter

Baseline, Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG002	ILV-094 100 mg Every 2 Weeks	Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

Health assessment questionnaire-disability index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to perform activity. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 4, 2, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG002

Secondary

36-Item Short-Form Health Survey (SF-36)

SF-36 is a standardized survey consisting of 36 items summarized into 8 multi-item scales evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality and mental health. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) derived are derived by aggregating the 8 aspects. The score for each aspect and physical and mental component summary are scaled 0-100 where, higher score indicating highest level of functioning.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 4, 8, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Secondary

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale

FACIT-fatigue is a 13-item questionnaire. Participants score each item on a 5-point scale ranging from 0 (not at all) to 4 (very much). The scoring algorithm is such that the item responses are reversed in score (except for 2 items, "I have energy" and "I am able to do my usual activities"), in order to reflect higher scores as less fatigue. The sum of all responses resulted in the FACIT-fatigue total score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 4, 8, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG002

Secondary

Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

DAS28-based EULAR response criteria was used to measure individual response as none, good and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.

mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Posted

Count of Participants

Participants

Week 2, 4, 6, 8, 10, 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
OG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG0031 affected48 at risk
Leukocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Leukopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Neutropenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Neutrophilia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Mitral valve incompetence	Cardiac disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Tachycardia paroxysmal	Cardiac disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Vertigo	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0021 affected42 at risk EG003
Hypothyroidism	Endocrine disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Blepharitis	Eye disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Cataract	Eye disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Conjunctivitis	Eye disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Conjunctivitis allergic	Eye disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Dry eye	Eye disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Eye irritation	Eye disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Hypermetropia	Eye disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Ocular hyperaemia	Eye disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Presbyopia	Eye disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Vision blurred	Eye disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0021 affected42 at risk EG003
Visual acuity reduced	Eye disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Apical granuloma	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Cheilitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0004 affected66 at risk EG0012 affected39 at risk EG0023 affected42 at risk EG003
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected39 at risk EG0021 affected42 at risk EG003
Flatulence	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Food poisoning	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected39 at risk EG0020 affected42 at risk EG003
Gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0021 affected42 at risk EG003
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0004 affected66 at risk EG0011 affected39 at risk EG0024 affected42 at risk EG003
Stomatitis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Toothache	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Umbilical hernia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected39 at risk EG0023 affected42 at risk EG003
Asthenia	General disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0022 affected42 at risk EG003
Chest discomfort	General disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Fatigue	General disorders	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Injection site haematoma	General disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Injection site haemorrhage	General disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Oedema	General disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Pain	General disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Pyrexia	General disorders	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Seasonal allergy	Immune system disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected39 at risk EG0020 affected42 at risk EG003
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0004 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Bronchitis bacterial	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Cystitis	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Diarrhoea infectious	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Diverticulitis	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Fungal skin infection	Infections and infestations	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected39 at risk EG0022 affected42 at risk EG003
Herpes zoster	Infections and infestations	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Infected skin ulcer	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Infection	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Influenza	Infections and infestations	Non-systematic Assessment	EG0003 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Lower respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG0002 affected66 at risk EG0012 affected39 at risk EG0024 affected42 at risk EG003
Oral herpes	Infections and infestations	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0023 affected42 at risk EG003
Pharyngitis	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0021 affected42 at risk EG003
Respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Rhinitis	Infections and infestations	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Staphylococcal infection	Infections and infestations	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Tinea pedis	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Tinea versicolour	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Tooth abscess	Infections and infestations	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Tooth infection	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Tracheitis	Infections and infestations	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Tracheobronchitis	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0004 affected66 at risk EG0014 affected39 at risk EG0021 affected42 at risk EG003
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0002 affected66 at risk EG0012 affected39 at risk EG0022 affected42 at risk EG003
Vaginal infection	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Viral diarrhoea	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Viral infection	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Concussion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Contusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0022 affected42 at risk EG003
Excoriation	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Joint injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Laceration	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Limb injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Synovial rupture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Alanine aminotransferase increased	Investigations	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected39 at risk EG0021 affected42 at risk EG003
Aspartate aminotransferase increased	Investigations	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0022 affected42 at risk EG003
Blood pressure increased	Investigations	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Cardiac murmur	Investigations	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Coagulation test abnormal	Investigations	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Liver function test abnormal	Investigations	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected39 at risk EG0023 affected42 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0022 affected42 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected39 at risk EG0021 affected42 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected39 at risk EG0021 affected42 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected39 at risk EG0020 affected42 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0023 affected42 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0021 affected42 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Acoustic neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Disturbance in attention	Nervous system disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0003 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Headache	Nervous system disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected39 at risk EG0022 affected42 at risk EG003
Paraesthesia	Nervous system disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Presyncope	Nervous system disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Sciatica	Nervous system disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Somnolence	Nervous system disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Tremor	Nervous system disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Depression	Psychiatric disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Emotional distress	Psychiatric disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Listless	Psychiatric disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Calculus urinary	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Costovertebral angle tenderness	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Dysuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Haematuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Micturition urgency	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Pollakiuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Urinary incontinence	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Breast tenderness	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Menorrhagia	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Prostatitis	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Calculus prostatic	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Nasal oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected39 at risk EG0021 affected42 at risk EG003
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Rhonchi	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Acne	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Hair colour changes	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0021 affected42 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Eczema weeping	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Hypertension	Vascular disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected39 at risk EG0020 affected42 at risk EG003
Hypotension	Vascular disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Phlebitis	Vascular disorders	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected39 at risk EG0020 affected42 at risk EG003
Varicose ulceration	Vascular disorders	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected39 at risk EG0020 affected42 at risk EG003

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	Title	Description
BG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
BG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
BG002	ILV-094 100 mg Every 2 Weeks	Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
BG003	ILV-094 200 mg Every 2 Weeks	Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	7	66	35	66
EG001	ILV-094 100 mg Every 4 Weeks	Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	2	39	29	39
EG002	ILV-094 100 mg Every 2 Weeks	Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	0	42	26	42
EG003	ILV-094 200 mg Every 2 Weeks	Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	0	48	28	48