Evaluation of Ixekizumab Using Auto-Injector or Prefilled... | NCT01777191

NCT01777191

ID	Type	Description	Link
I1F-MC-RHBL	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
80 mg Ixekizumab Auto-Injector	Experimental	Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every 2 weeks (Q2W) at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection every 4 weeks (Q4W).	Drug: Ixekizumab Auto-Injector
80 mg Ixekizumab Prefilled Syringe	Experimental	Ixekizumab administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection Q4W.	Drug: Ixekizumab Prefilled Syringe

Name	Type	Description	Arm Group Labels	Other Names
Ixekizumab Auto-Injector	Drug	Administered SC by auto-injector	80 mg Ixekizumab Auto-Injector

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device	Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.	Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device	AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.	Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)

Secondary Outcomes

Measure	Description	Time Frame
PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)	Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.	Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Anaheim	California	92801

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27500949	Result	Callis Duffin K, Bagel J, Bukhalo M, Mercado Clement IJ, Choi SL, Zhao F, Gill A, Pangallo B, Shuler C, Mallbris L, Jackson K. Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER-A). J Eur Acad Dermatol Venereol. 2017 Jan;31(1):107-113. doi: 10.1111/jdv.13768. Epub 2016 Aug 8.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 milligrams (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every two weeks (Q2W) at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose every 4 weeks (Q4W).

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

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

FG000102 subjects
FG001102 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
BG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046.3± 14.53 BG00146.8± 13.09 BG00246.5± 13.80

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00031 BG00131 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00033 BG00129 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Puerto Rico

Title	Measurements
	BG00019 BG00120 BG002

Baseline in Psoriasis Area and Severity Index (PASI)

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00021.05± 9.379 BG001

Baseline in Static Physician Global Assessment (sPGA) Score

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. The sPGA is recommended as an endpoint to use to assess efficacy in the treatment of Ps (EMEA 2004). Overall lesions are categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's Ps is assessed at a given time point on a 6-point scale in which 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate; 4 = severe, 5 = very severe.

Number

participants

Title

Denominators

Categories

sPGA=3

Title	Measurements
	BG00055 BG001

Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ)

SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from "Strongly Disagree" to "Strongly Agree"). 1 represents "Strongly Disagree" and 7 represents "Strongly Agree".

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Easy for me to learn how to use (n=99,101)

Title	Measurements
	BG0006.4± 1.08 BG001

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

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device

Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.

All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.

Posted

Geometric Mean

90% Confidence Interval

micrograms/milliliter (µg/mL)

Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Units	Counts
Participants	OG00094 OG00198

Title

Denominators

Categories

Title	Measurements
	OG00015.0(13.9 to 16.1) OG00114.8(13.8 to 15.9)

Primary

PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device

AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.

All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.

Posted

Geometric Mean

90% Confidence Interval

micrograms*day/milliliter (µg*day/mL)

Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Secondary

PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)

Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.

All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.

Posted

Geometric Mean

90% Confidence Interval

µg/ml

Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Units	Counts
Participants

Secondary

PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)

AUC 0-tlast by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.

All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.

Posted

Geometric Mean

90% Confidence Interval

µg*day/mL

Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Units	Counts

Secondary

PK: Cmax by Body Weight

Cmax by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. Body weight is defined by (Low: <80 kilogram (kg), Medium: 80-100 kg, or High: >100 kg).

All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)

ID	Title	Description
OG000	80 mg Ixekizumab	Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Units	Counts
Participants	OG000

Secondary

PK: AUC 0-tlast by Body Weight

AUC 0-tlast by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. Body weight is defined by (Low: <80 kg, Medium: 80-100 kg, or High: >100 kg).

All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.

Posted

Geometric Mean

90% Confidence Interval

µg*day/mL

Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)

ID	Title	Description
OG000	80 mg Ixekizumab	Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)

PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease. Participants achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 90%, or of 100%, respectively, in the PASI scores compared to baseline.

All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Secondary

Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA)

The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Secondary

Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).

All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Secondary

Percentage of Device Operation Failures

Device operation failure (that is, incomplete dose administration) was defined as an event during the treatment period (week 0 to week 12) when the participant indicated that a complete dose of ixekizumab was not delivered and/or the drug delivery device did not perform as expected per the directions for use.

All randomized participants.

Posted

Number

percentage of incomplete injections

Baseline through Week 12

Injections

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Units	Counts

Secondary

Percentage of Participants With Anti-Ixekizumab Antibodies

The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at anytime post-baseline were summarized by drug delivery device group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.

All randomized participants who received a least 1 dose of study drug during the Treatment Period and had evaluable data.

Posted

Number

percentage of participants

Baseline to Week 12

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Secondary

SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)

The SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from "Strongly Disagree" to "Strongly Agree"). 1 represents "Strongly Disagree" while 7 represents "Strongly Agree". The ease of use and confidence of ixekizumab subcutaneous administrations across drug delivery device groups were evaluated by SQAAQ item scores at each post baseline visit.

All randomized participants.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 4 and Week 8

ID	Title	Description
OG000	80 mg Ixekizumab Prefilled Syringe	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
OG001	80 mg Ixekizumab Auto-Injector	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	80 mg Ixekizumab Prefilled Syringe Treatment Period	Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.	3	102	12	102
EG001	80 mg Ixekizumab Auto-Injector Treatment Period	Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.	4	102	10	102
EG002	80 mg Ixe Prefilled Syringe Optional Safety Extension	One 80 mg Ixekizumab administered as an SC injection Q4W.	9	185	24	185
EG003	Follow Up Period	All participants who received at least 1 dose of Ixekizumab entered the follow-up period.	1	176	0	176

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected185 at risk EG0030 events0 affected176 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected185 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0022 events1 affected185 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected185 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected185 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected185 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected185 at risk EG003
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected185 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected185 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected185 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected185 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected185 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected185 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0023 events2 affected185 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Injection site reaction	General disorders	MedDRA 18.0	Systematic Assessment		EG00012 events8 affected102 at risk EG0018 events5 affected102 at risk EG0028 events8 affected185 at risk EG0030 events0 affected176 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0004 events4 affected102 at risk EG0015 events5 affected102 at risk EG00219 events16 affected185 at risk EG003

ID	Term
C549079	ixekizumab

Units	Counts
Participants	OG00094 OG00198

Units	Counts
Participants	OG000102 OG00199