Efficacy at 24 Weeks and Safety, Tolerability and Long Te... | NCT01350804

ID	Type	Description	Link
2011-000102-21	EudraCT Number

Efficacy at 24 Weeks and Safety, Tolerability and Long Te... | NCT01350804 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AIN457 10mg/kg - 75 mg	Experimental	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks	Biological: AIN457
AIN457 10mg/kg - 150 mg	Experimental	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks	Biological: AIN457
Placebo	Placebo Comparator	Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.	Biological: AIN457 Biological: Placebo
Abatacept	Active Comparator	Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).	Biological: AIN457 Biological: Abatacept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AIN457	Biological	AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).	ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.	week 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)	The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Anniston	Alabama	36207-5710	United States
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31087226	Derived	Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.
28217871

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
FG001	AIN457 10mg/kg - 150 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Withdrawal by Subject		FG00011 subjects FG00117 subjects FG00216 subjects FG0037 subjects
Study terminated by Sponsor		FG0000 subjects FG0010 subjects FG0020 subjects FG0032 subjects
Protocol deviation		FG0001 subjects FG0010 subjects FG0021 subjects FG0030 subjects
Physician Decision		FG0001 subjects FG0010 subjects FG0021 subjects FG0033 subjects
Lost to Follow-up		FG0003 subjects FG0010 subjects FG0022 subjects FG0031 subjects
Lack of Efficacy		FG00016 subjects FG00119 subjects FG00218 subjects FG0035 subjects
Death		FG0001 subjects FG0011 subjects FG0021 subjects FG0030 subjects
Adverse Event		FG0008 subjects FG00110 subjects FG0028 subjects FG0038 subjects

Extension Study, Weeks 52 - 260

Type	Comment	Milestone Data
STARTED		FG00080 subjects FG00179 subjects FG00272 subjectsDuring the extension, these participants received AIN457. FG00323 subjectsDuring the extension, these participants received AIN457.
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects
NOT COMPLETED		FG00080 subjects FG00179 subjects FG00272 subjects FG00323 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0005 subjects FG0016 subjects FG0024 subjects FG003

Arm/Group Information

ID	Title	Description
BG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
BG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
BG002	Placebo	Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
BG003	Abatacept	Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000119 BG001109 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).

ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.

Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.

Posted

Number

Percentage of participants

week 24

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
OG002	Placebo	Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
OG003	Abatacept	Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).

Units	Counts
Participants	OG000138 OG001137 OG002138 OG003

Title

Denominators

Categories

Title	Measurements
	OG00028.3 OG00130.7 OG00218.1 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 OG002		Regression, Logistic		0.0458		Odds Ratio (OR)	1.79			2-Sided	95	1.0	3.2				No	Superiority or Other
OG001 OG002		Regression, Logistic		0.0152

Secondary

Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)

The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.

Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.

Posted

Least Squares Mean

Standard Error

score on a scale

baseline, week 24

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
OG002	Placebo	Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.

Secondary

Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)

The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.

Posted

Least Squares Mean

Standard Error

score on a scale

baseline, week 24

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg

Secondary

Percentage of Participants Achieving ACR50

ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation.

Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.

Posted

Number

Percentage of participants

week 24

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
OG002	Placebo

Secondary

Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation

ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).

Participants from the full analysis set were considered for the analysis. Participants with missing data were considered non-responders at the respective time point. Placebo and Abatacept participants were considered non-responders from the time of treatment switch.

Posted

Number

Percentage of participants

baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.

Secondary

Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data

Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.

Posted

Number

Percentage of participants

baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg

Secondary

Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM)

The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.

Participants from the full analysis set were considered for this analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups.

Posted

Least Squares Mean

Standard Error

score on a scale

baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.

Secondary

Change From Baseline in HAQ-DI - Observed Data

Posted

Mean

Standard Deviation

score on a scale

baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001

Secondary

Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM

Participants from the full analysis set were considered for the analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups

Posted

Least Squares Mean

Standard Error

score on a scale

baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
OG002	Placebo	Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.

Secondary

Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data

Posted

Mean

Standard Deviation

score on a scale

baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.

Secondary

Change From Baseline in hsCRP - Observed Data

Blood samples were obtained to identify the presence of inflammation, to determine its severity and to monitor response to treatment. A negative change from baseline indicates improvement. The hsCRP results from baseline up to week 52 were based on observed data, i.e. without imputation.

Posted

Mean

Standard Deviation

mg/L

baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
OG002	Placebo	Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.

Secondary

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data

Blood samples were obtained to monitor disease activity and response to treatment. A negative change from baseline indicates improvement. The ESR results from baseline up to week 52 were based on observed data, i.e. without imputation.

Posted

Mean

Standard Deviation

mm/hr

baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	AIN457 10mg/kg - 75 mg	Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
OG001	AIN457 10mg/kg - 150 mg	Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
OG002	Placebo	Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Any AIN457 75 mg	Any AIN457 75 mg	30	218	144	218
EG001	Any AIN457 150 mg	Any AIN457 150 mg	28	215	146	215
EG002	Placebo	Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.	7	139	51	139
EG003	Abatacept	Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).	9	137	78	137

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG0030 affected137 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0021 affected139 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Palpitations	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0021 affected139 at risk EG003
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Cataract	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0021 affected139 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Intestinal polyp	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Cyst	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Death	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Device dislocation	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
General physical health deterioration	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Eye abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0021 affected139 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Herpes zoster oticus	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Joint abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Septic shock	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Procedural headache	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Acquired claw toe	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected215 at risk EG0021 affected139 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0012 affected215 at risk EG0020 affected139 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0012 affected215 at risk EG0020 affected139 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected218 at risk EG0012 affected215 at risk EG0020 affected139 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0012 affected215 at risk EG0020 affected139 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Formication	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Meningorrhagia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Perineurial cyst	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0021 affected139 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0021 affected139 at risk EG003
Delirium	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0021 affected139 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Rectocele	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected215 at risk EG0020 affected139 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0020 affected139 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected218 at risk EG00110 affected215 at risk EG0028 affected139 at risk EG0036 affected137 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected218 at risk EG0014 affected215 at risk EG0020 affected139 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected218 at risk EG0015 affected215 at risk EG0024 affected139 at risk EG003
Neutrophilia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected218 at risk EG0012 affected215 at risk EG0023 affected139 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected215 at risk EG0024 affected139 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0015 affected215 at risk EG0020 affected139 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00016 affected218 at risk EG00112 affected215 at risk EG0020 affected139 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected218 at risk EG0013 affected215 at risk EG0021 affected139 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected218 at risk EG0015 affected215 at risk EG0022 affected139 at risk EG003
Oedema peripheral	General disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected218 at risk EG0016 affected215 at risk EG0020 affected139 at risk EG003
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected218 at risk EG0019 affected215 at risk EG0021 affected139 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00010 affected218 at risk EG00112 affected215 at risk EG0020 affected139 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0008 affected218 at risk EG0014 affected215 at risk EG0020 affected139 at risk EG003
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0007 affected218 at risk EG00113 affected215 at risk EG0021 affected139 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00024 affected218 at risk EG00117 affected215 at risk EG0024 affected139 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0013 affected215 at risk EG0020 affected139 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00010 affected218 at risk EG0015 affected215 at risk EG0021 affected139 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected218 at risk EG0015 affected215 at risk EG0020 affected139 at risk EG003
Rhinitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0008 affected218 at risk EG00112 affected215 at risk EG0021 affected139 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0009 affected218 at risk EG0017 affected215 at risk EG0022 affected139 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0006 affected218 at risk EG0013 affected215 at risk EG0020 affected139 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0005 affected218 at risk EG0011 affected215 at risk EG0021 affected139 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00018 affected218 at risk EG00121 affected215 at risk EG0029 affected139 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00016 affected218 at risk EG00110 affected215 at risk EG0022 affected139 at risk EG003
Viral infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0016 affected215 at risk EG0020 affected139 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected218 at risk EG0015 affected215 at risk EG0021 affected139 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 affected218 at risk EG0017 affected215 at risk EG0023 affected139 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0004 affected218 at risk EG0013 affected215 at risk EG0020 affected139 at risk EG003
Lipoprotein (a) increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected218 at risk EG0016 affected215 at risk EG0020 affected139 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected218 at risk EG0013 affected215 at risk EG0021 affected139 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected218 at risk EG0017 affected215 at risk EG0026 affected139 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected218 at risk EG00111 affected215 at risk EG0022 affected139 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected218 at risk EG0012 affected215 at risk EG0023 affected139 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected218 at risk EG0013 affected215 at risk EG0023 affected139 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00017 affected218 at risk EG00115 affected215 at risk EG0021 affected139 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected218 at risk EG0015 affected215 at risk EG0022 affected139 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00012 affected218 at risk EG00110 affected215 at risk EG0022 affected139 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected218 at risk EG0015 affected215 at risk EG0021 affected139 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected218 at risk EG0017 affected215 at risk EG0021 affected139 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected218 at risk EG0014 affected215 at risk EG0020 affected139 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00019 affected218 at risk EG00122 affected215 at risk EG0026 affected139 at risk EG003
Rheumatoid nodule	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0015 affected215 at risk EG0020 affected139 at risk EG003
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected218 at risk EG0012 affected215 at risk EG0020 affected139 at risk EG003
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00018 affected218 at risk EG00111 affected215 at risk EG0024 affected139 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected218 at risk EG0015 affected215 at risk EG0021 affected139 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected218 at risk EG0014 affected215 at risk EG0020 affected139 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected218 at risk EG0015 affected215 at risk EG0023 affected139 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected218 at risk EG0015 affected215 at risk EG0020 affected139 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected218 at risk EG0015 affected215 at risk EG0020 affected139 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected215 at risk EG0021 affected139 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected218 at risk EG0014 affected215 at risk EG0021 affected139 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG00020 affected218 at risk EG00110 affected215 at risk EG0024 affected139 at risk EG003

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

Title

Denominators

Categories

ACR20, week 1

Title	Measurements
	OG00021.0 OG00117.5 OG0027.2 OG00310.9

ACR20, week 2

Title	Measurements
	OG00024.6 OG00121.2 OG00212.3 OG003

ACR20, week 4

Title	Measurements
	OG00034.1 OG00127.0 OG00221.7 OG003

ACR20, week 8

Title	Measurements
	OG00035.5 OG00141.6 OG00221.0 OG003

ACR20, week 12

Title	Measurements
	OG00028.3 OG00133.6 OG00224.6 OG003

ACR20, week 16

Title	Measurements
	OG00034.1 OG00139.4 OG00223.2 OG003

ACR20, week 20

Title	Measurements
	OG00026.8 OG00138.0 OG00218.1 OG003

ACR20, week 24

Title	Measurements
	OG00028.3 OG00130.7 OG00218.1 OG003

ACR50, week 1

Title	Measurements
	OG0006.5 OG0012.9 OG0020.7 OG003

ACR50, week 2

Title	Measurements
	OG0005.1 OG0018.8 OG0022.9 OG003

ACR50, week 4

Title	Measurements
	OG0009.4 OG00110.2 OG0022.9 OG003

ACR50, week 8

Title	Measurements
	OG0007.2 OG00115.3 OG00210.1 OG003

ACR50, week 12

Title	Measurements
	OG0008.7 OG00113.1 OG00210.1 OG003

ACR50, week 16

Title	Measurements
	OG00013.8 OG00120.4 OG0029.4 OG003

ACR50, week 20

Title	Measurements
	OG00012.3 OG00118.2 OG0028.0 OG003

ACR50, week 24

Title	Measurements
	OG00011.6 OG00116.8 OG0029.4 OG003

ACR70, week 1

Title	Measurements
	OG0000.7 OG0010.7 OG0020.0 OG003

ACR70, week 2

Title	Measurements
	OG0001.4 OG0010.7 OG0021.4 OG003

ACR70, week 4

Title	Measurements
	OG0004.3 OG0012.9 OG0021.4 OG003

ACR70, week 8

Title	Measurements
	OG0001.4 OG0014.4 OG0022.9 OG003

ACR70, week 12

Title	Measurements
	OG0002.2 OG0012.9 OG0022.9 OG003

ACR70, week 16

Title	Measurements
	OG0005.1 OG0018.0 OG0022.9 OG003

ACR70, week 20

Title	Measurements
	OG0004.3 OG0017.3 OG0025.8 OG003

ACR70, week 24

Title	Measurements
	OG0005.1 OG00110.2 OG0025.1 OG003

Title

Denominators

Categories

ACR20,wk 1,n=132,129,130,130,39,35,21,22,96,17,17

Title	Measurements
	OG00022.7 OG00118.6 OG0027.7 OG00311.5 OG0045.1 OG0055.7 OG00614.3 OG00713.6 OG00814.6 OG0090.0 OG0105.9

ACR20,wk 2,n=131,130,134,134,39,36,23,22,99,17,18

Title	Measurements
	OG00026.7 OG00122.3 OG00212.7 OG003

ACR20,wk 4,n=133,132,131,129,39,39,23,21,93,17,19

Title	Measurements
	OG00036.1 OG00128.0 OG00222.9 OG003

ACR20,wk 8,n=132,127,131,131,39,39,23,22,95,17,19

Title	Measurements
	OG00038.6 OG00144.9 OG00222.1 OG003

ACR20,wk 12,n=130,115,123,129,39,37,23,21,94,17,18

Title	Measurements
	OG00030.8 OG00140.0 OG00227.6 OG003

ACR20,wk 16,n=126,118,116,129,36,37,21,22,94,16,19

Title	Measurements
	OG00038.1 OG00145.8 OG00227.6 OG003

ACR20,wk 20,n=122,114,119,126,38,37,23,21,91,16,19

Title	Measurements
	OG00039.3 OG00151.8 OG00242.9 OG003

ACR20,wk 24,n=117,110,117,121,38,36,21,22,87,16,18

Title	Measurements
	OG00045.3 OG00148.2 OG00240.2 OG003

ACR20,wk28,n=115,103,na,na,33,35,21,21,86,17,19

Title	Measurements
	OG00047.8 OG00165.0 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR20,wk32,n=104,97,na,na,33,30,21,19,87,17,17

Title	Measurements
	OG00056.7 OG00161.9 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR20,wk36,n=102,93,na,na,30,30,21,20,85,18,16

Title	Measurements
	OG00056.9 OG00153.8 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR20,wk40,n=96,90,na,na,28,28,21,19,85,15,17

Title	Measurements
	OG00053.1 OG00161.1 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR20,wk44,n=97,90,na,na,28,27,20,18,84,15,16

Title	Measurements
	OG00056.7 OG00161.1 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR20,wk48,n=94,89,na,na,28,26,18,19,77,12,14

Title	Measurements
	OG00057.4 OG00168.5 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR20,wk52,n=92,88,na,na,28,26,20,18,79,15,15

Title	Measurements
	OG00056.5 OG00162.5 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR50,wk1,n=132,129,130,130,39,35,21,22,96,17,17

Title	Measurements
	OG0006.8 OG0013.1 OG0020.8 OG003

ACR50,wk2,n=131,130,134,134,39,36,23,22,99,17,18

Title	Measurements
	OG0005.3 OG0019.2 OG0023.0 OG003

ACR50,wk4,n=133,132,131,129,39,39,23,21,93,17,19

Title	Measurements
	OG0009.8 OG00110.6 OG0023.1 OG003

ACR50,wk8,n=132,127,131,131,39,39,23,22,95,17,19

Title	Measurements
	OG0009.1 OG00116.5 OG00210.7 OG003

ACR50,wk12,n=130,115,123,129,39,37,23,21,94,17,18

Title	Measurements
	OG00010.0 OG00115.7 OG00211.4 OG003

ACR50,wk16,n=126,118,116,129,36,37,21,22,94,16,19

Title	Measurements
	OG00015.9 OG00123.7 OG00211.2 OG003

ACR50,wk20,n=122,114,119,126,38,37,23,21,91,16,19

Title	Measurements
	OG00015.6 OG00121.9 OG00212.6 OG003

ACR50,wk24,n=117,110,117,121,38,36,21,22,87,16,18

Title	Measurements
	OG00014.5 OG00122.7 OG00214.5 OG003

ACR50,wk28,n=115,103,na,na,33,35,21,21,86,17,19

Title	Measurements
	OG00013.9 OG00131.1 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR50,wk32,n=104,97,na,na,33,30,21,19,87,17,17

Title	Measurements
	OG00021.2 OG00132.0 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR50,wk36,n=102,93,na,na,30,30,21,20,85,18,16

Title	Measurements
	OG00023.5 OG00124.7 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR50,wk40,n=96,90,na,na,28,28,21,19,85,15,17

Title	Measurements
	OG00025.0 OG00125.6 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR50,wk44,n=97,90,na,na,28,27,20,18,84,15,16

Title	Measurements
	OG00027.8 OG00130.0 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR50,wk48,n=94,89,na,na,28,26,18,19,77,12,14

Title	Measurements
	OG00025.5 OG00142.7 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR50,wk52,n=92,88,na,na,28,26,20,18,79,15,15

Title	Measurements
	OG00026.1 OG00145.5 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR70,wk1,n=132,129,130,130,39,35,21,22,96,17,17

Title	Measurements
	OG0000.8 OG0010.8 OG0020.0 OG003

ACR70,wk2,n=131,130,134,134,39,36,23,22,99,17,18

Title	Measurements
	OG0001.5 OG0010.8 OG0021.5 OG003

ACR70,wk4,n=133,132,131,129,39,39,23,21,93,17,19

Title	Measurements
	OG0004.5 OG0013.0 OG0021.5 OG003

ACR70,wk8,n=132,127,131,131,39,39,23,22,95,17,19

Title	Measurements
	OG0001.5 OG0014.7 OG0023.1 OG003

ACR70,wk12,n=130,115,123,129,39,37,23,21,94,17,18

Title	Measurements
	OG0003.1 OG0013.5 OG0023.3 OG003

ACR70,wk16,n=126,118,116,129,36,37,21,22,94,16,19

Title	Measurements
	OG0006.3 OG0019.3 OG0023.4 OG003

ACR70,wk20,n=122,114,119,126,38,37,23,21,91,16,19

Title	Measurements
	OG0006.6 OG0018.8 OG0026.7 OG003

ACR70,wk24,n=117,110,117,121,38,36,21,22,87,16,18

Title	Measurements
	OG0006.0 OG00112.7 OG0028.5 OG003

ACR70,wk28,n=115,103,na,na,33,35,21,21,86,17,19

Title	Measurements
	OG0006.1 OG00117.5 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR70,wk32,n=104,97,na,na,33,30,21,19,87,17,17

Title	Measurements
	OG0004.8 OG00110.0 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR70,wk36,n=102,93,na,na,30,30,21,20,85,18,16

Title	Measurements
	OG0005.9 OG00111.8 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR70,wk40,n=96,90,na,na,28,28,21,19,85,15,17

Title	Measurements
	OG0008.3 OG00111.1 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR70,wk44,n=97,90,na,na,28,27,20,18,84,15,16

Title	Measurements
	OG00012.4 OG00118.9 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR70,wk48,n=94,89,na,na,28,26,18,19,77,12,14

Title	Measurements
	OG0009.6 OG00120.2 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ACR70,wk52,n=92,88,na,na,28,26,20,18,79,15,15

Title	Measurements
	OG0006.5 OG00119.3 OG002NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Title

Denominators

Categories

week 1, n=132,129,130,129

Title	Measurements
	OG000-0.22± 0.032 OG001-0.21± 0.032 OG002-0.08± 0.032 OG003-0.19± 0.032

week 2, n=131,130,134,133

Title	Measurements
	OG000-0.22± 0.036 OG001-0.25± 0.036 OG002-0.16± 0.036 OG003

week 4, n=133,133,131,130

Title	Measurements
	OG000-0.30± 0.039 OG001-0.31± 0.040 OG002-0.17± 0.040 OG003

week 8, n=132,127,131,130

Title	Measurements
	OG000-0.29± 0.042 OG001-0.32± 0.043 OG002-0.17± 0.043 OG003

week 12, n=130,114,123,129

Title	Measurements
	OG000-0.31± 0.046 OG001-0.33± 0.047 OG002-0.18± 0.047 OG003

week 16, n=127,118,116,129

Title	Measurements
	OG000-0.30± 0.048 OG001-0.37± 0.049 OG002-0.22± 0.049 OG003

week 20, n=122,114,47,92

Title	Measurements
	OG000-0.36± 0.051 OG001-0.42± 0.052 OG002-0.21± 0.066 OG003

week 24, n=117,110,44,86

Title	Measurements
	OG000-0.30± 0.049 OG001-0.39± 0.051 OG002-0.26± 0.065 OG003

Title

Denominators

Categories

wk1,n=132,129,130,129,39,35,21,22,95,17,17

Title	Measurements
	OG000-0.225± 0.3766 OG001-0.215± 0.4095 OG002-0.101± 0.3186 OG003-0.194± 0.4290 OG004-0.119± 0.2896 OG005-0.079± 0.3093 OG006-0.125± 0.4257 OG007-0.153± 0.2468 OG008-0.232± 0.4551 OG009-0.081± 0.3616 OG010-0.096± 0.3047

Wk2,n=131,130,134,133,39,36,23,22,133,98,17,18

Title	Measurements
	OG000-0.215± 0.3877 OG001-0.239± 0.4885 OG002-0.191± 0.4340 OG003

Wk4,n=133,133,131,130,39,39,23,21,94,17,19

Title	Measurements
	OG000-0.299± 0.4551 OG001-0.300± 0.5184 OG002-0.214± 0.4492 OG003

Wk8,n=132,127,131,130,39,39,23,22,94,17,19

Title	Measurements
	OG000-0.277± 0.5062 OG001-0.309± 0.5175 OG002-0.217± 0.5457 OG003

wk12,n=130,114,123,129,39,37,23,21,94,17,18

Title	Measurements
	OG000-0.287± 0.5384 OG001-0.307± 0.5488 OG002-0.241± 0.5152 OG003

Wk16,n=127,118,116,129,36,37,21,22,94,16,19

Title	Measurements
	OG000-0.294± 0.5236 OG001-0.355± 0.6217 OG002-0.279± 0.5493 OG003

Wk20,n=122,114,119,125,38,37,23,21,90,16,19

Title	Measurements
	OG000-0.333± 0.5111 OG001-0.402± 0.6429 OG002-0.319± 0.5637 OG003

Wk24,n=117,110,117,120,38,36,21,22,86,16,18

Title	Measurements
	OG000-0.268± 0.4930 OG001-0.405± 0.5767 OG0020.346± 0.5941 OG003

Wk28,n=115,102,na,na,33,35,21,21,86,17,19

Title	Measurements
	OG000-0.304± 0.5342 OG001-0.439± 0.5780 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk32,n=104,97,na,na,33,30,21,19,87,17,17

Title	Measurements
	OG000-0.358± 0.4964 OG001-0.505± 0.5759 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk36,n=102,93,na,na,30,30,21,19,84,18,16,

Title	Measurements
	OG000-0.339± 0.5687 OG001-0.430± 0.5573 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk40,n=96,89,na,na,28,28,21,19,84,15,17

Title	Measurements
	OG000-0.424± 0.5967 OG001-0.440± 0.5416 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk44,n=97,90,na,na,28,27,20,18,84,15,16

Title	Measurements
	OG000-0.331± 0.5871 OG001-0.449± 0.5427 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk48,n-94,89,na,na,28,26,19,19,76,12,14

Title	Measurements
	OG000-0.303± 0.5062 OG001-0.483± 0.5459 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk52,n=92,87,na,na,28,26,20,18,79,15,15

Title	Measurements
	OG000-0.341± 0.5428 OG001-0.516± 0.6036 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Title

Denominators

Categories

week 1, n=131,129,130,129

Title	Measurements
	OG000-0.89± 0.069 OG001-0.73± 0.069 OG002-0.22± 0.069 OG003-0.50± 0.069

week 2, n=131,127,132,133

Title	Measurements
	OG000-0.96± 0.080 OG001-0.90± 0.081 OG002-0.35± 0.080 OG003

week 4, n=130,131,138,138

Title	Measurements
	OG000-1.20± 0.090 OG001-1.11± 0.090 OG002-0.48± 0.090 OG003

week 8, n=130,126,130,130

Title	Measurements
	OG000-1.21± 0.093 OG001-1.23± 0.094 OG002-0.61± 0.093 OG003

week 12, n=130,114,123,128

Title	Measurements
	OG000-1.23± 0.097 OG001-1.36± 0.102 OG002-0.73± 0.100 OG003

week 16, n=126,116,114,127

Title	Measurements
	OG000-1.23± 0.108 OG001-1.40± 0.112 OG002-0.57± 0.112 OG003

week 20, n=121,114,47,92

Title	Measurements
	OG000-1.44± 0.108 OG001-1.49± 0.111 OG002-0.89± 0.146 OG003

week 24, n=116,108,44,84

Title	Measurements
	OG000-1.47± 0.115 OG001-1.47± 0.119 OG002-1.02± 0.163 OG003

Title

Denominators

Categories

Wk1,n=131,129,130,129,39,35,21,22, 95,17,17

Title	Measurements
	OG000-0.886± 0.9784 OG001-0.759± 0.8654 OG002-0.211± 0.6877 OG003-0.502± 0.7539 OG004-0.147± 0.5527 OG005-0.141± 0.7095 OG006-0.572± 0.7856 OG007-0.235± 0.7699 OG008-0.577± 0.7924 OG009-0.361± 0.3578 OG010-0.222± 0.7695

Wk2,n=131,127,132,133,39,36,23,21,98,17,18

Title	Measurements
	OG000-0.909± 1.0331 OG001-0.900± 1.0284 OG002-0.363± 0.8388 OG003

Wk4,n=130,131,129,128,39,38,23,21,92,17,19

Title	Measurements
	OG000-1.163± 1.1656 OG001-1.150± 1.1942 OG002-0.492± 0.8876 OG003

Wk8,n=130,126,130,130,39,39,23,22,94,17,19

Title	Measurements
	OG000-1.181± 1.1821 OG001-1.283± 1.1678 OG002-0.644± 1.1356 OG003

Wk12,n=130,114,123,128,39,37,23,21,93,17,18

Title	Measurements
	OG000-1.229± 1.1782 OG001-1.402± 1.2182 OG002-0.742± 1.2330 OG003

Wk16,n=126,116,114,128,36,36,21,21,94,15,19

Title	Measurements
	OG000-1.225± 1.2866 OG001-1.455± 1.3489 OG002-0.592± 1.2557 OG003

Wk20,n=121,114,,119,125,38,37,23,21,90,16,19

Title	Measurements
	OG000-1.427± 1.3266 OG001-1.569± 1.2361 OG002-1.164± 1.2087 OG003

Wk24,n=116,108,116,117,37,36,21,22,84,15,18

Title	Measurements
	OG000-1.467± 1.3116 OG001-1.579± 1.3221 OG002-1.248± 1.2915 OG003

Wk28,n=115,103,na,na,33,35,21,21,86,17,18

Title	Measurements
	OG000-1.484± 1.3216 OG001-1.819± 1.3434 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk32,n=103,97,na,na,33,39,23,22,87,17,16

Title	Measurements
	OG000-1.738± 1.2783 OG001-1.966± 1.1770 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk36,n=101,92,na,na,30,30,21,20,84,18,15

Title	Measurements
	OG000-1.737± 1.4592 OG001-1.820± 1.2500 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk40,n=96,90,na,na,28,28,21,19,84,15,17

Title	Measurements
	OG000-1.742± 1.3259 OG001-1.788± 1.1333 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk44,n=96,88,na,na,28,27,20,18,84,15,16

Title	Measurements
	OG000-1.764± 1.3227 OG001-1.932± 1.2850 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk48,n=94,88,na,na,28,26,18,19,76,12,14

Title	Measurements
	OG000-1.761± 1.3152 OG001-2.200± 1.3293 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk52,n=92,86,na,na,28,26,20,18,79,15,15

Title	Measurements
	OG000-1.839± 1.3755 OG001-2.109± 1.4000 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Title

Denominators

Categories

Wk1,n=134,130,131,131,39,36,21,22,97,17,17

Title	Measurements
	OG000-10.91± 30.815 OG001-10.31± 27.754 OG002-0.69± 15.521 OG003-5.64± 18.550 OG004-0.33± 10.430 OG005-0.84± 24.777 OG006-0.40± 12.244 OG007-1.50± 7.541 OG008-6.40± 20.458 OG009-2.92± 12.405 OG010-4.07± 10.811

Wk2,n=133,129,133,135,39,36,23,21,100,17,18

Title	Measurements
	OG000-10.24± 33.209 OG001-11.51± 32.139 OG002-2.21± 14.501 OG003

Wk4,n=131,134,129,133,39,38,23,21,97,17,19

Title	Measurements
	OG000-9.10± 20.514 OG001-10.76± 33.376 OG002-1.53± 19.311 OG003

Wk8,n=134,128,130,132,39,39,23,22,96,17,19

Title	Measurements
	OG000-10.18± 33.400 OG001-12.94± 30.854 OG002-2.94± 20.601 OG003

Wk12,n=133,119,128,131,39,39,23,22,96,17,18

Title	Measurements
	OG000-9.41± 31.859 OG001-9.66± 24.298 OG002-0.69± 18.908 OG003

Wk16,n=129,120,121,131,36,38,21,21,96,16,19

Title	Measurements
	OG000-9.97± 33.291 OG001-5.78± 25.418 OG002-1.82± 20.849 OG003

Wk20,n=124,116,120,127,38,37,23,21,91,17,19

Title	Measurements
	OG000-9.19± 32.876 OG001-8.05± 22.394 OG002-3.75± 29.301 OG003

Wk24,n=121,113,116,120,37,36,21,22,86,16,18

Title	Measurements
	OG000-6.90± 22.098 OG001-4.92± 23.075 OG002-6.88± 21.014 OG003

Wk28,n=119,110,na,na,34,35,21,21,89,17,18

Title	Measurements
	OG000-4.94± 23.155 OG001-5.87± 25.885 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk32,n=107,101,na,na,34,32,20,21,87,17,16

Title	Measurements
	OG000-8.57± 20.826 OG0017.37± 24.564 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk36,n=107,98,na,na,32,31,21,20,85,18,15

Title	Measurements
	OG000-6.60± 25.895 OG001-6.36± 22.571 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

WK40,n=101,96,na,na,29,29,22,20,86,15,17

Title	Measurements
	OG000-8.74± 22.257 OG001-7.09± 24.325 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk44,n=97,92,na,na,,28,28,20,19,85,15,16

Title	Measurements
	OG000-6.59± 20.975 OG001-7.25± 24.681 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk48,n=97,91,na,na,28,29,20,19,79,13,14

Title	Measurements
	OG000-6.19± 18.912 OG001-7.63± 21.682 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk52,n=95,92,na,na,29,28,20,18,83,16,16

Title	Measurements
	OG000-6.68± 26.240 OG001-8.14± 22.149 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Title

Denominators

Categories

Wk1,n=133,130,131,131,39,36,21,22,97,17,17,

Title	Measurements
	OG000-7.5± 18.74 OG001-8.4± 19.20 OG002-5.7± 15.68 OG003-9.5± 16.55 OG004-8.4± 12.65 OG005-1.1± 18.88 OG006-5.7± 14.97 OG007-7.1± 13.22 OG008-10.2± 17.11 OG009-7.7± 13.90 OG010-7.2± 16.30

Wk2,n=133,130,135,134,39,36,23,22,99,17,18

Title	Measurements
	OG000-12.2± 19.06 OG001-10.5± 19.05 OG002-5.7± 18.22 OG003

Wk4,n=133,135,131,133,39,39,23,21,97,17,19

Title	Measurements
	OG000-12.7± 22.23 OG001-12.1± 21.88 OG002-6.0± 18.90 OG003

Wk8,n=133,129,131,132,39,39,23,22,96,17,19

Title	Measurements
	OG000-15.4± 20.38 OG001-15.7± 21.62 OG002-6.4± 22.72 OG003

Wk12,n=133,118,127,131,39,39,23,21,96,17,18

Title	Measurements
	OG000-14.7± 20.08 OG001-18.4± 21.18 OG002-5.8± 21.02 OG003

Wk16,n=129,121,122,130,36,38,21,22,95,16,19

Title	Measurements
	OG000-16.2± 21.22 OG001-15.6± 19.09 OG002-6.5± 23.48 OG003

Wk20,n=123,116,120,127,38,37,23,21,91,17,19

Title	Measurements
	OG000-16.3± 20.90 OG001-17.7± 19.90 OG002-9.1± 26.29 OG003

Wk24,n=122,113,117,123,38,36,21,22,88,17,18

Title	Measurements
	OG000-13.9± 23.65 OG001-16.0± 20.20 OG002-12.0± 24.31 OG003

Wk28,n=119,110,na,na,34,35,21,21,89,17,19

Title	Measurements
	OG000-15.4± 22.95 OG001-16.8± 23.05 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk32,n=108,101,na,na,34,32,21,21,88,17,16

Title	Measurements
	OG000-18.3± 23.51 OG001-17.4± 21.57 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk36,n=107,98,na,na,32,31,21,20,87,18,16

Title	Measurements
	OG000-16.6± 25.20 OG001-18.4± 21.51 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk40,n=101,96,na,na,29,29,22,20,85,15,17

Title	Measurements
	OG000-18.1± 21.06 OG001-17.3± 21.05 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk44,n=98,93,na,na,28,28,20,19,85,15,16

Title	Measurements
	OG000-18.0± 21.08 OG001-16.7± 23.87 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk48,n=97,92,na,na,28,30,20,19,79,13,14

Title	Measurements
	OG000-17.8± 23.11 OG001-19.8± 20.30 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

Wk52,n=94,91,na,na,29,28,20,18,83,16,16

Title	Measurements
	OG000-17.7± 21.08 OG001-20.6± 23.48 OG002NA± NAAfter week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only. OG003

ID	Term
D018796	Immunoconjugates
D000906	Antibodies
D007136	Immunoglobulins
D012712	Serum Globulins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D005916	Globulins