Safety and Efficacy of Secukinumab Compared to Etanercept... | NCT01358578

NCT01358578

ID	Type	Description	Link
2010-022228-66

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AIN457 150mg	Experimental	AIN457 150mg	Drug: Placebo Drug: secukinumab (AIN457)
AIN457 300mg	Experimental	AIN457 300mg	Drug: Placebo Drug: secukinumab (AIN457)
Placebo	Placebo Comparator	Placebo	Drug: Placebo
Etanercept	Active Comparator	Etanercept	Drug: Placebo Drug: etanercept
AIN457 150mg from Placebo	Experimental	Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase	Drug: Placebo Drug: secukinumab (AIN457)
AIN457 300mg from Placebo	Experimental	Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept	AIN457 150mg AIN457 150mg from Placebo AIN457 300mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .	A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis	12 wks
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12	The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.	12 wks

Secondary Outcomes

Measure	Description	Time Frame
Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12	A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis	12 wks

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35205	United States
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37341961	Derived	Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.
35305260

Label	URL
A Plain Language Trial Summary is available on novartisclinicaltrials.com	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
FG001	AIN457 300mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00045.4± 12.92 BG00144.5± 13.19 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00091 BG001103 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00028 BG00122 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

Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .

A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis

Posted

Number

participants achieving goal

12 wks

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG002	Placebo	s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:

Units	Counts
Participants	OG000327 OG001323 OG002324

Title

Denominators

Categories

Title	Measurements
	OG000219 OG001249 OG00216

Primary

Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12

The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.

Posted

Number

participants acheiving goal

12 wks

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48

Secondary

Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12

A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis

FAS

Posted

Number

participant who acheived goal

12 wks

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG002	Etanercept	Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.

Secondary

Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12

A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis

FAS

Posted

Number

participant who acheived goal

12 wks

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG002	Etanercept	Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.

Secondary

Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12

FAS

Posted

Number

participant acheiving goal

12 wks

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48

Secondary

Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)

Full analysis set

Posted

Number

participants who reached goal

52 wks

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG002	Etanercept	Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.

Secondary

Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment

Full analysis set

Posted

Number

participants who reached goal

52 wks

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG002	Etanercept	Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.

Secondary

Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo

The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy

Full analysis set

Posted

Mean

Standard Error

units on scale

baseline to week 12

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48

Secondary

Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept

Full analysis set

Posted

Mean

Standard Error

Units on a scale

baseline to week 12

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48

Secondary

Number of Participants Developing Anti-secukinumab Antibodies

Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)

Full Analysis Set

Posted

Number

# participants tested positive

60 weeks

ID	Title	Description
OG000	AIN457 150mg	s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG001	AIN457 300mg	s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
OG002	PLACEBO-150 mg AIN457	Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
OG003	PLACEBO-300 mg AIN457

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	INDUCTION-AIN457 150mg	INDUCTION-AIN457 150mg	7	327	157	327
EG001	INDUCTION-AIN457 300mg	INDUCTION-AIN457 300mg	4	326	145	326
EG002	INDUCTION-Placebo	INDUCTION-Placebo	6	327	121	327
EG003	INDUCTION-Etanercept	INDUCTION-Etanercept	3	323	130	323
EG004	ENTIRE-AIN457 150mg	ENTIRE-AIN457 150mg	18	327	225	327
EG005	ENTIRE-AIN457 300mg	ENTIRE-AIN457 300mg	21	326	230	326
EG006	ENTIRE-Any AIN457 150mg	ENTIRE-Any AIN457 150mg	24	469	297	469
EG007	ENTIRE-Any AIN457 300mg	ENTIRE-Any AIN457 300mg	27	467	316	467
EG008	ENTIRE-Placebo	ENTIRE-Placebo	7	327	122	327
EG009	ENTIRE-Etanercept	ENTIRE-Etanercept	20	323	213	323
EG010	FOLLOW UP-Any AIN457 150mg	FOLLOW UP-Any AIN457 150mg	2	148	25	148
EG011	FOLLOW UP-Any AIN457 300mg	FOLLOW UP-Any AIN457 300mg	2	125	11	125
EG012	FOLLOW UP-Placebo	FOLLOW UP-Placebo	0	27	7	27
EG013	FOLLOW UP-Etanercept	FOLLOW UP-Etanercept	2	278	59	278

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG0030 affected323 at risk EG0040 affected327 at risk EG0050 affected326 at risk EG0060 affected469 at risk EG0070 affected467 at risk EG0080 affected327 at risk EG0090 affected323 at risk EG0100 affected148 at risk EG0110 affected125 at risk EG0120 affected27 at risk EG0131 affected278 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
ANGINA UNSTABLE	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PALPITATIONS	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
BASEDOW'S DISEASE	Endocrine disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HYPERTHYROIDISM	Endocrine disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PARATHYROID GLAND ENLARGEMENT	Endocrine disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
THYROTOXIC CRISIS	Endocrine disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
ANAL FISTULA	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
COLITIS ULCERATIVE	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
OESOPHAGEAL FOOD IMPACTION	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
POLYSEROSITIS	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
ACUTE TONSILLITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
ANAL ABSCESS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0011 affected326 at risk EG0020 affected327 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
CELLULITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0021 affected327 at risk EG003
DIVERTICULITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HEPATITIS B	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PERIRECTAL ABSCESS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PHARYNGOTONSILLITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
TONSILLITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0021 affected327 at risk EG003
CARTILAGE INJURY	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
LACERATION	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0011 affected326 at risk EG0021 affected327 at risk EG003
POST PROCEDURAL HYPOTHYROIDISM	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
POSTOPERATIVE RESPIRATORY DISTRESS	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0011 affected326 at risk EG0020 affected327 at risk EG003
TENDON INJURY	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0021 affected327 at risk EG003
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
CHONDROPATHY	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
JOINT INSTABILITY	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PSORIATIC ARTHROPATHY	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
FACIAL PARESIS	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HYPOAESTHESIA	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
SCIATICA	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
VIITH NERVE PARALYSIS	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
VITH NERVE PARALYSIS	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
DEPRESSION SUICIDAL	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
DRUG ABUSE	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
CALCULUS URETHRAL	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
RENAL COLIC	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PROSTATOMEGALY	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0011 affected326 at risk EG0020 affected327 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
DYSHIDROTIC ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
LICHEN SCLEROSUS	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PAIN OF SKIN	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PSORIASIS	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0022 affected327 at risk EG003
ABSTAINS FROM ALCOHOL	Social circumstances	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0021 affected327 at risk EG003
ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
BEHCET'S SYNDROME	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
CONJUNCTIVITIS	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0013 affected326 at risk EG0021 affected327 at risk EG0030 affected323 at risk EG0043 affected327 at risk EG0059 affected326 at risk EG0063 affected469 at risk EG00710 affected467 at risk EG0081 affected327 at risk EG0093 affected323 at risk EG0100 affected148 at risk EG0111 affected125 at risk EG0120 affected27 at risk EG0130 affected278 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0013 affected326 at risk EG0024 affected327 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0004 affected327 at risk EG0012 affected326 at risk EG0024 affected327 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00012 affected327 at risk EG00117 affected326 at risk EG0026 affected327 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected327 at risk EG0018 affected326 at risk EG0027 affected327 at risk EG003
TOOTHACHE	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected327 at risk EG0016 affected326 at risk EG0025 affected327 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0014 affected326 at risk EG0021 affected327 at risk EG003
ADVERSE DRUG REACTION	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
FATIGUE	General disorders	MedDRA 16.0	Systematic Assessment	EG0005 affected327 at risk EG0017 affected326 at risk EG0023 affected327 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0012 affected326 at risk EG0021 affected327 at risk EG003
INJECTION SITE ERYTHEMA	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA 16.0	Systematic Assessment	EG0005 affected327 at risk EG0011 affected326 at risk EG0024 affected327 at risk EG003
PYREXIA	General disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0015 affected326 at risk EG0023 affected327 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0004 affected327 at risk EG0014 affected326 at risk EG0022 affected327 at risk EG003
EAR INFECTION	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0011 affected326 at risk EG0021 affected327 at risk EG003
FOLLICULITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0004 affected327 at risk EG0010 affected326 at risk EG0021 affected327 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0003 affected327 at risk EG0015 affected326 at risk EG0022 affected327 at risk EG003
IMPETIGO	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0014 affected326 at risk EG0020 affected327 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0005 affected327 at risk EG0015 affected326 at risk EG0023 affected327 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00044 affected327 at risk EG00135 affected326 at risk EG00226 affected327 at risk EG003
ORAL CANDIDIASIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0012 affected326 at risk EG0020 affected327 at risk EG003
ORAL HERPES	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0015 affected326 at risk EG0020 affected327 at risk EG003
PHARYNGITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0005 affected327 at risk EG0014 affected326 at risk EG0020 affected327 at risk EG003
RHINITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0004 affected327 at risk EG0017 affected326 at risk EG0024 affected327 at risk EG003
SINUSITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0005 affected327 at risk EG0010 affected326 at risk EG0021 affected327 at risk EG003
TINEA PEDIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0003 affected327 at risk EG0013 affected326 at risk EG0020 affected327 at risk EG003
TONSILLITIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0003 affected327 at risk EG0012 affected326 at risk EG0022 affected327 at risk EG003
TOOTH ABSCESS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0021 affected327 at risk EG003
TRICHOMONIASIS	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00010 affected327 at risk EG0017 affected326 at risk EG0023 affected327 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0012 affected326 at risk EG0023 affected327 at risk EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0011 affected326 at risk EG0021 affected327 at risk EG003
MUSCLE RUPTURE	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0012 affected326 at risk EG0023 affected327 at risk EG003
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected327 at risk EG0011 affected326 at risk EG0025 affected327 at risk EG003
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0013 affected326 at risk EG0022 affected327 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected327 at risk EG0011 affected326 at risk EG0023 affected327 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00014 affected327 at risk EG0015 affected326 at risk EG00210 affected327 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0008 affected327 at risk EG0018 affected326 at risk EG0026 affected327 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected327 at risk EG0012 affected326 at risk EG0021 affected327 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected327 at risk EG0013 affected326 at risk EG0024 affected327 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0015 affected326 at risk EG0024 affected327 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00016 affected327 at risk EG00130 affected326 at risk EG00223 affected327 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0011 affected326 at risk EG0022 affected327 at risk EG003
URETHRAL HAEMORRHAGE	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected327 at risk EG0010 affected326 at risk EG0020 affected327 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected327 at risk EG00111 affected326 at risk EG0024 affected327 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0004 affected327 at risk EG0019 affected326 at risk EG0027 affected327 at risk EG003
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0017 affected326 at risk EG0021 affected327 at risk EG003
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected327 at risk EG0013 affected326 at risk EG0020 affected327 at risk EG003
ERYTHRODERMIC PSORIASIS	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0011 affected326 at risk EG0020 affected327 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00012 affected327 at risk EG0018 affected326 at risk EG00211 affected327 at risk EG003
PSORIASIS	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0005 affected327 at risk EG0011 affected326 at risk EG0027 affected327 at risk EG003
SEBORRHOEIC DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected327 at risk EG0012 affected326 at risk EG0020 affected327 at risk EG003
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0005 affected327 at risk EG0011 affected326 at risk EG0020 affected327 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG00010 affected327 at risk EG0015 affected326 at risk EG0024 affected327 at risk EG003

Ancestor Terms

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D007127	Immunoglobulin Constant Regions
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins
D018124	Receptors, Tumor Necrosis Factor
D018121	Receptors, Cytokine
D011971	Receptors, Immunologic
D011956	Receptors, Cell Surface
D008565	Membrane Proteins

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Title	Description
BG000	AIN457 150mg	AIN457 150mg
BG001	AIN457 300mg	AIN457 300mg
BG002	Placebo	Placebo
BG003	Etanercept	Etanercept
BG004	Total	Total of all reporting groups