Safety and Tolerability of AIN457 in Adults (18-65 Years)... | NCT01109940

NCT01109940

ID	Type	Description	Link
2009-011591-30

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
AIN457	Experimental		Biological: AIN457A

Name	Type	Description	Arm Group Labels	Other Names
AIN457A	Biological		AIN457

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Reported Adverse Events (AE's)	AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.	From start of the study up to 64 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Reported Positive Antibodies for Secukinumab	Immunogenicity (anti-drug antibodies) was assessed using an MSD bridging assay and a 3-tiered approach (screening, confirmation, titration).	Pre-dose, Week 0, 8, 24, 40 and Week 64
Total Interleukin (IL)- 17A Concentration in Blood at Steady-State

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Paradise Valley	Arizona	85253	United States
Novartis Investigative Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dose Group 1	Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Dose Group 1	Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
BG001	Dose Group 2	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
BG002	Dose Group 3	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
BG003	Secukinumab/Placebo	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received placebo in the core study (CAIN457A2209 [NCT00809159]).
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00021 BG0018 BG0027 BG0033 BG00439

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00039.5± 7.56 BG00147.9± 11.27 BG00245.9± 8.61 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00010 BG0014 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00018 BG0018 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

Number of Participants Reported Adverse Events (AE's)

AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.

Safety analysis set.

Posted

Count of Participants

Participants

From start of the study up to 64 weeks

ID	Title	Description
OG000	Dose Group 1	Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG001	Dose Group 2	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG002	Dose Group 3	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG003	Secukinumab/Placebo	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received placebo in the core study (CAIN457A2209 [NCT00809159]).

Units	Counts
Participants	OG00021 OG0018 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG00021 OG0016 OG0026 OG003

Secondary

Number of Participants Reported Positive Antibodies for Secukinumab

Immunogenicity (anti-drug antibodies) was assessed using an MSD bridging assay and a 3-tiered approach (screening, confirmation, titration).

Safety analysis set.

Posted

Count of Participants

Participants

Pre-dose, Week 0, 8, 24, 40 and Week 64

ID	Title	Description
OG000	Dose Group 1	Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG001	Dose Group 2	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG002	Dose Group 3	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).

Secondary

Total Interleukin (IL)- 17A Concentration in Blood at Steady-State

Total serum IL17A was not measured due to assay limitations.

IL-17A measurements were planned for this study but could not be measured because the assay for total IL-17A, samples was not robust.

Posted

Pre-dose and at the end of infusion (up to 64 weeks)

ID	Title	Description
OG000	Dose Group 1	Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG001	Dose Group 2	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG002	Dose Group 3	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).

Secondary

Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss)

Concentration of Secukinumab at the end of infusion (Cmax,ss) was reported.

All completed participants with quantifiable pharmacokinetics (PK) measurements and no major protocol deviations with impact on PK data were included in the PK analysis set. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

micrograms per milliliter (μg/mL)

At end of infusion (Week 64)

ID	Title	Description
OG000	Dose Group 1	Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG001	Dose Group 2	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG002	Dose Group 3	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).

Secondary

Minimum (Trough) Observed in Serum at Steady State (Cmin,ss)

The concentration of secukinumab at pre-dose (Cmin,ss) in serum was reported.

Posted

Mean

Standard Deviation

micrograms per milliliter (μg/mL)

Pre-dose (Week 0)

ID	Title	Description
OG000	Dose Group 1	Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG001	Dose Group 2	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).
OG002	Dose Group 3	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dose Group-1	Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x10 mg/kg in the core study (CAIN457A2209 [NCT00809159]).	21	4	21	18	21
EG001	Dose Group-2	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x1.0 mg/kg in the core study (CAIN457A2209 [NCT00809159]).	8	1	8	6	8
EG002	Dose Group-3	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received secukinumab 2x0.1 mg/kg in the core study (CAIN457A2209 [NCT00809159]).	7	0	7	6	7
EG003	Placebo/Secukinumab	Participants received 3 mg/kg of IV secukinumab for every 4 weeks up to one year in the extension study (CAIN457A2209E1 [NCT01109940]) and who received placebo in the core study (CAIN457A2209 [NCT00809159]).	3	0	3	3	3

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Crohn's disease	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG0030 affected3 at risk
Folliculitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Sinusitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Staphylococcal abscess	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Depression	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG0030 affected3 at risk
Palpitations	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0012 affected8 at risk EG0021 affected7 at risk EG003
Ear congestion	Ear and labyrinth disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Dry eye	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Iritis	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Uveitis	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Vision blurred	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Catheter site inflammation	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Chest discomfort	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Fatigue	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected21 at risk EG0012 affected8 at risk EG0020 affected7 at risk EG003
Influenza like illness	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Oedema peripheral	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Pyrexia	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Bronchitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Cellulitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Eye infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Infected dermal cyst	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0021 affected7 at risk EG003
Influenza	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0012 affected8 at risk EG0020 affected7 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG00010 affected21 at risk EG0010 affected8 at risk EG0022 affected7 at risk EG003
Paronychia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Sinusitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0021 affected7 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Procedural headache	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Blood pressure increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Weight decreased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0022 affected7 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Articular disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Bone swelling	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0021 affected7 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Headache	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0022 affected7 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Sciatica	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Mood swings	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected21 at risk EG0012 affected8 at risk EG0021 affected7 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0010 affected8 at risk EG0021 affected7 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003
Hypertension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected21 at risk EG0010 affected8 at risk EG0020 affected7 at risk EG003
Staphylococcal abscess	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected21 at risk EG0011 affected8 at risk EG0020 affected7 at risk EG003

ID	Term
D013167	Spondylitis, Ankylosing

Ancestor Terms

ID	Term
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D000844	Ankylosis
D007592	Joint Diseases
D001168	Arthritis