Extension Study to Assess Effects of Non-interrupted Vers... | NCT04179175

NCT04179175

ID	Type	Description	Link
2023-508956-20	Registry Identifier	CTIS (EU) Number

Description Module

Label	Type	Description	Intervention Names
secukinumab 1 HiSCR Responder	Active Comparator	HiSCR responder at Week 52 in core trial, secukinumab 300mg every 2 weeks	Drug: secukinumab
secukinumab 2 HiSCR Responder	Active Comparator	HiSCR responder at Week 52 in core trial, secukinumab 300mg every 4 weeks	Drug: secukinumab
placebo 1 HiSCR Responder	Placebo Comparator	HiSCR responder at Week 52 in core trial, placebo to secukinumab 300mg every 2 weeks	Drug: secukinumab
placebo 2 HiSCR Responder	Placebo Comparator	HiSCR responder at Week 52 in core trial, placebo to secukinumab 300 mg every 4 weeks	Drug: secukinumab
HiSCR non-responders	Other	non-responder at Week 52 in core trial treatment; secukinumab 300mg every 2 weeks	Drug: secukinumab

Name	Type	Description	Arm Group Labels	Other Names
secukinumab	Drug	secukinumab 300mg every 2 weeks	HiSCR non-responders placebo 1 HiSCR Responder secukinumab 1 HiSCR Responder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders	Loss of response was defined as: at least a 50% increase in abscess and/or nodules (AN) count compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN. at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks	Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders	The incidence rate of participants achieving Loss of Response (LOR) was based on the primary estimand. Day 1 = Date of 1st dose intake in the extension study. Subjects at risk = Subjects who did not have LOR and were not censored before or at the start of the specified time interval. Incidence rate (%) = (number of subjects with LOR / number of subjects at risk) x 100.	Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events	To assess the long-term safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa (HS)	Up to 216 weeks: from randomization at the extension study (Week 52) up to Week 268. Study day is defined with respect to the core studies.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Northwest Arkansas Center		Rogers	Arkansas	72758	United States
MedDerm Associates

PubMed Identifier	Type	Citation	Retractions
39611771	Derived	Kimball AB, Bechara FG, Badat A, Giamarellos-Bourboulis EJ, Gottlieb AB, Jemec GBE, Reguiai Z, Villani AP, Alarcon I, Bansal A, Gasperoni F, Martin R, Paguet B, Uhlmann L, Zouater H, Ravichandran S, Alavi A. Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial. Br J Dermatol. 2025 Mar 18;192(4):629-640. doi: 10.1093/bjd/ljae469.

ID	Title	Description
FG000	AIN457 Q2WR-Q2W	HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 28, 2020	May 24, 2024

Arm/Group Information

ID	Title	Description
BG000	AIN457 Q2WR-Q2W	HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W
BG001	AIN457 Q2WR-PBO	HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W
BG002	AIN457 Q4WR-Q4W	HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.
BG003	AIN457 Q4WR-PBO	HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion
BG004	AIN457 Q2WNR-Q2W	HiSCR non-responders at Week 52 who were on secukinumab every 2 weeks (Q2W) in the core studies and stay on Q2W in the extension
BG005	AIN457 Q4WNR-Q2W	HiSCR non-responders at Week 52 who were on secukinumab every 4 weeks (Q4W) in the core studies and are up-titrated to Q2W in the extension
BG006	Total	Total of all reporting groups

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

Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders

Loss of response was defined as:

at least a 50% increase in abscess and/or nodules (AN) count compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN.
at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks

Full Analysis Set of HiSCR responders (FAS-R)

Posted

Median

95% Confidence Interval

Days

Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.

ID	Title	Description
OG000	AIN457 Q2WR-Q2W	HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W
OG001	AIN457 Q2WR-PBO	HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W
OG002	AIN457 Q4WR-Q4W	HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.
OG003	AIN457 Q4WR-PBO	HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion
OG004	AIN457 Q2WNR-Q2W	HiSCR non-responders at Week 52 who were on secukinumab every 2 weeks (Q2W) in the core studies and stay on Q2W in the extension
OG005	AIN457 Q4WNR-Q2W	HiSCR non-responders at Week 52 who were on secukinumab every 4 weeks (Q4W) in the core studies and are up-titrated to Q2W in the extension

Units	Counts
Participants	OG000136 OG00171 OG002121 OG003

Title

Denominators

Categories

Title	Measurements
	OG000283(176 to NA)N/A: Not estimable due to insufficient number of participants with events OG001239(120 to NA)N/A: Not estimable due to insufficient number of participants with events OG002

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	one-sided stratified log-rank test, with region and body weight (<90 kg, ≥ 90 kg) as strata	0.250		Hazard Ratio (HR)	0.87			2-Sided	95	0.59	1.29					Other
OG002 OG003		Log Rank

Secondary

Number of Participants With Treatment Emergent Adverse Events

To assess the long-term safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa (HS)

Not Posted

Jul 2027

Up to 216 weeks: from randomization at the extension study (Week 52) up to Week 268. Study day is defined with respect to the core studies.

Participants

Primary

Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders

The incidence rate of participants achieving Loss of Response (LOR) was based on the primary estimand.

Day 1 = Date of 1st dose intake in the extension study.
Subjects at risk = Subjects who did not have LOR and were not censored before or at the start of the specified time interval.
Incidence rate (%) = (number of subjects with LOR / number of subjects at risk) x 100.

Full Analysis Set of HiSCR responders (FAS-R) with an available value for the outcome measure.

Posted

Number

Percentage of participants

Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.

ID	Title	Description
OG000	AIN457 Q2WR-Q2W	HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W
OG001	AIN457 Q2WR-PBO	HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AIN457 Q2WR-Q2W	HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	137	2	137	44	137
EG001	AIN457 Q2WR-PBO	HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	70	4	70	23	70
EG002	AIN457 Q4WR-Q4W	HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.	121	5	121	46	121
EG003	AIN457 Q4WR-PBO	HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion	63	5	63	16	63
EG004	Any AIN457 Q4W	All subjects that have been exposed to secukinumab every 4 weeks (Q4W) in the extension study	180	11	180	71	180
EG005	Any AIN457 Q2W	All subjects that have been exposed to secukinumab every 2 weeks (Q2W) in the extension study, regardless of responder status at Week 52, including those who up-titrated	637	72	637	379	637
EG006	Any AIN457	All subjects exposed to Secukinumab in the extension study regardless of the assigned drug regimen, and regardless of responder status	687	80	687	428	687
EG007	AIN457 NR	All subjects who are HiSCR non-responders	307	37	307	199	307

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG0030 affected63 at risk EG0040 affected180 at risk EG0051 affected637 at risk EG0061 affected687 at risk EG0071 affected307 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0021 affected121 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Keratitis	Eye disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Intussusception	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Strangulated umbilical hernia	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Tongue coated	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Chest pain	General disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
General physical health deterioration	General disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Abscess	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Appendicitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0021 affected121 at risk EG003
Breast abscess	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
COVID-19	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0011 affected70 at risk EG0020 affected121 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Cellulitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Dermatitis infected	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0011 affected70 at risk EG0020 affected121 at risk EG003
Groin abscess	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0011 affected70 at risk EG0020 affected121 at risk EG003
Influenza	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Meningitis viral	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Pneumonia	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0001 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Sepsis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Sweat gland infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0021 affected121 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Skin scar contracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
C-reactive protein increased	Investigations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Fibrosis tendinous	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0011 affected70 at risk EG0020 affected121 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Colloid brain cyst	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Optic perineuritis	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Syncope	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0021 affected121 at risk EG003
Depression	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Labia enlarged	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Perineal induration	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Aorto-bronchial fistula	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0001 affected137 at risk EG0010 affected70 at risk EG0021 affected121 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG0030 affected63 at risk EG0041 affected180 at risk EG0058 affected637 at risk EG0069 affected687 at risk EG0078 affected307 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0011 affected70 at risk EG0021 affected121 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 affected137 at risk EG0012 affected70 at risk EG0022 affected121 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0011 affected70 at risk EG0020 affected121 at risk EG003
Fatigue	General disorders	MedDRA (26.0)	Systematic Assessment	EG0002 affected137 at risk EG0010 affected70 at risk EG0022 affected121 at risk EG003
Pyrexia	General disorders	MedDRA (26.0)	Systematic Assessment	EG0003 affected137 at risk EG0013 affected70 at risk EG0021 affected121 at risk EG003
Body tinea	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0003 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Bronchitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0002 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
COVID-19	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG00011 affected137 at risk EG0016 affected70 at risk EG00211 affected121 at risk EG003
Cellulitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Ear infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0001 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Folliculitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0012 affected70 at risk EG0023 affected121 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0003 affected137 at risk EG0010 affected70 at risk EG0022 affected121 at risk EG003
Influenza	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0002 affected137 at risk EG0011 affected70 at risk EG0022 affected121 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0005 affected137 at risk EG0012 affected70 at risk EG0026 affected121 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0023 affected121 at risk EG003
Sinusitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0001 affected137 at risk EG0010 affected70 at risk EG0021 affected121 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0021 affected121 at risk EG003
Sweat gland infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0004 affected137 at risk EG0011 affected70 at risk EG0021 affected121 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0002 affected137 at risk EG0011 affected70 at risk EG0020 affected121 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0001 affected137 at risk EG0010 affected70 at risk EG0023 affected121 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0003 affected137 at risk EG0012 affected70 at risk EG0022 affected121 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0012 affected70 at risk EG0020 affected121 at risk EG003
C-reactive protein increased	Investigations	MedDRA (26.0)	Systematic Assessment	EG0001 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0012 affected70 at risk EG0024 affected121 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0003 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0023 affected121 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0002 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Headache	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0003 affected137 at risk EG0010 affected70 at risk EG0024 affected121 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0024 affected121 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0023 affected121 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0003 affected137 at risk EG0010 affected70 at risk EG0021 affected121 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0012 affected70 at risk EG0020 affected121 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0011 affected70 at risk EG0022 affected121 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0021 affected121 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0003 affected137 at risk EG0014 affected70 at risk EG0023 affected121 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0006 affected137 at risk EG0014 affected70 at risk EG0024 affected121 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0024 affected121 at risk EG003
Perioral dermatitis	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0001 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003
Hypertension	Vascular disorders	MedDRA (26.0)	Systematic Assessment	EG0000 affected137 at risk EG0010 affected70 at risk EG0020 affected121 at risk EG003

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012874	Skin Diseases, Infectious
D013492	Suppuration
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D016575	Hidradenitis
D013543	Sweat Gland Diseases