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Clinical Trial Results:
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis

Summary
EudraCT number	2015-000190-12
Trial protocol	DE HU CZ PL RO
Global end of trial date	03 Aug 2017

Results information
Results version number	v1(current)
This version publication date	18 Aug 2018
First version publication date	18 Aug 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I1F-MC-RHBP

ISRCTN number

US NCT number

NCT02513550

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 15988

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

03 Aug 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

03 Aug 2017

Was the trial ended prematurely?

Main objective of the trial

To compare the efficacy of continuous every 2-week (Q2W) dosing versus continuous every 4-week (Q4W) dosing of ixekizumab in the treatment of patients with moderate-to-severe plaque psoriasis (Ps), as measured by static Physician Global Assessment (sPGA) (0,1) and PASI 75 (75% improvement from baseline in the Psoriasis Area and Severity Index).

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Aug 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Puerto Rico: 59

Country: Number of subjects enrolled

Argentina: 37

Country: Number of subjects enrolled

Romania: 19

Country: Number of subjects enrolled

Hungary: 44

Country: Number of subjects enrolled

United States: 474

Country: Number of subjects enrolled

Czech Republic: 14

Country: Number of subjects enrolled

Japan: 16

Country: Number of subjects enrolled

Canada: 196

Country: Number of subjects enrolled

Korea, Republic of: 75

Country: Number of subjects enrolled

Taiwan: 20

Country: Number of subjects enrolled

Poland: 169

Country: Number of subjects enrolled

Mexico: 35

Country: Number of subjects enrolled

Australia: 56

Country: Number of subjects enrolled

Germany: 41

Worldwide total number of subjects

1255

EEA total number of subjects

287

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

1107

From 65 to 84 years

148

85 years and over

Subject disposition

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Recruitment details

As pre-specified in the analysis plan for the trial, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Screening details

N/A

Period 1 title

Double Blind Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

80 mg Ixekizumab Q4W

Arm description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

LY2439821

Other name

Taltz

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

A starting dose of 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

80 mg Ixekizumab Q4W/Q2W

Arm description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

LY2439821

Other name

Taltz

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

A starting dose of 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.

80 mg Ixekizumab Q2W

Arm description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

LY2439821

Other name

Taltz

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

A starting dose of ixekizumab 160 mg (Week 0) given as 2 SC injections followed by ixekizumab 80 mg given as 1 SC injection Q2W until Week 52. Placebo administered SQ, Q2W to maintain blind.

80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort

Arm description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

LY2439821

Other name

Taltz

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

A starting dose of 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort

Arm description

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

LY2439821

Other name

Taltz

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort

Arm description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

LY2439821

Other name

Taltz

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

A starting dose of ixekizumab 160 mg (Week 0) given as 2 SC injections followed by ixekizumab 80 mg given as 1 SC injection Q2W until Week 52. Placebo administered SQ, Q2W to maintain blind.

Number of subjects in period 1	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W	80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort
Started	310	306	609	9	5	16
Received at least one dose of study drug	310	306	609	9	5	16
Completed	274	268	537	9	4	15
Not completed	36	38	72	0	1	1
Adverse event, serious fatal	1	-	2	-	-	-
Consent withdrawn by subject	11	11	24	-	-	-
Physician decision	2	-	4	-	-	-
Adverse event, non-fatal	5	13	17	-	1	-
Site terminated by sponsor	1	1	3	-	-	-
Due to personal business	2	-	1	-	-	-
Met exclusion criteria and was not dosed	-	-	1	-	-	-
Lost to follow-up	9	7	11	-	-	1
Lack of efficacy	4	5	6	-	-	-
Protocol deviation	1	1	3	-	-	-

Period 2 title

Post-Treatment Follow-up Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

80 mg Ixekizumab Q4W

Arm description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

80 mg Ixekizumab Q4W/Q2W

Arm description

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

80 mg Ixekizumab Q2W

Arm description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort

Arm description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort

Arm description

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort

Arm description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 2	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W	80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort
Started	285	283	559	9	4	15
Completed	254	244	496	9	4	15
Not completed	31	39	63	0	0	0
Adverse event, serious fatal	-	-	1	-	-	-
Consent withdrawn by subject	12	20	26	-	-	-
Physician decision	2	-	-	-	-	-
Early terminated but completed follow-up	12	16	20	-	-	-
Adverse event, non-fatal	1	1	4	-	-	-
Labor Reasons	-	-	1	-	-	-
Subject move out of town	-	-	1	-	-	-
Lost to follow-up	4	2	7	-	-	-
Subject did not come for Visit-802	-	-	3	-	-	-

Baseline characteristics

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Reporting group title

80 mg Ixekizumab Q4W

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W/Q2W

Reporting group description

Reporting group title

80 mg Ixekizumab Q2W

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort

Reporting group description

Reporting group title

80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W	80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort	Total
Number of subjects	310	306	609	9	5	16	1255
Age categorical
Units: Subjects
In utero							0
Preterm newborn infants (gestational age < 37 wks)							0
Newborns (0-27 days)							0
Infants and toddlers (28 days-23 months)							0
Children (2-11 years)							0
Adolescents (12-17 years)							0
Adults (18-64 years)							0
From 65-84 years							0
85 years and over							0
Age Continuous
Units: years
arithmetic mean (standard deviation)	47.4 ( 13.50 )	45.9 ( 12.85 )	49.0 ( 13.61 )	40.0 ( 9.62 )	46.0 ( 13.17 )	46.1 ( 13.05 )	-
Gender categorical
Units: Subjects
Female	111	107	199	2	0	4	423
Male	199	199	410	7	5	12	832
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	59	55	111	0	0	0	225
Not Hispanic or Latino	243	244	487	9	5	16	1004
Unknown or Not Reported	8	7	11	0	0	0	26
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	11	12	23	0	0	0	46
Asian	31	32	64	9	5	16	157
Native Hawaiian or Other Pacific Islander	0	0	4	0	0	0	4
Black or African American	14	8	22	0	0	0	44
White	251	253	484	0	0	0	988
More than one race	3	1	12	0	0	0	16
Unknown or Not Reported	0	0	0	0	0	0	0
Region of Enrollment
Units: Subjects
Puerto Rico	14	16	29	0	0	0	59
Argentina	9	9	19	0	0	0	37
Romania	5	5	9	0	0	0	19
Hungary	11	10	23	0	0	0	44
United States	119	118	237	0	0	0	474
Czechia	3	3	8	0	0	0	14
Japan	5	2	9	0	0	0	16
Canada	49	49	98	0	0	0	196
South Korea	11	12	22	9	5	16	75
Taiwan	5	6	9	0	0	0	20
Poland	43	43	83	0	0	0	169
Mexico	10	8	17	0	0	0	35
Australia	14	14	28	0	0	0	56
Germany	12	11	18	0	0	0	41

End points

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Reporting group title

80 mg Ixekizumab Q4W

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W/Q2W

Reporting group description

Reporting group title

80 mg Ixekizumab Q2W

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort

Reporting group description

Reporting group title

80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W/Q2W

Reporting group description

Reporting group title

80 mg Ixekizumab Q2W

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Reporting group title

80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort

Reporting group description

Reporting group title

80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort

Reporting group description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Subject analysis set title

80 mg Ixekizumab Q4W continuous

Subject analysis set type

Full analysis

Subject analysis set description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Subject analysis set title

80 mg Ixekizumab Q4W/Q2W No Step

Subject analysis set type

Full analysis

Subject analysis set description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Subject analysis set title

80 mg Ixekizumab Q4W/Q2W Step up

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

80 mg Ixekizumab Q2W continuous

Subject analysis set type

Full analysis

Subject analysis set description

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Primary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)

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End point title

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) ^[1]

End point description

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 analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.

End point type

Primary

End point timeframe

Week 52

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	310	306	609
Units: Percentage of participants
number (not applicable)	70.6	72.5	78.6

(sPGA) of (0,1)

Comparison groups

80 mg Ixekizumab Q4W v 80 mg Ixekizumab Q2W

Number of subjects included in analysis

919

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005

Method

Regression, Logistic

Parameter type

Risk difference (RD)

Point estimate

7.9

Confidence interval

level

95%

sides

2-sided

lower limit

1.9

upper limit

13.9

(sPGA) of (0,1)

Comparison groups

80 mg Ixekizumab Q4W v 80 mg Ixekizumab Q4W/Q2W

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.522

Method

Regression, Logistic

Parameter type

Risk difference (RD)

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-5.2

upper limit

Primary: Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)

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End point title

Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) ^[2]

End point description

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). All randomized participants analyzed according to the treatment to which they were assigned.

End point type

Primary

End point timeframe

Week 52

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	310	306	609
Units: Percentage of participants
number (not applicable)	79	83.7	85.9

PASI 75

Comparison groups

80 mg Ixekizumab Q4W v 80 mg Ixekizumab Q2W

Number of subjects included in analysis

919

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006

Method

Regression, Logistic

Parameter type

Risk difference (RD)

Point estimate

6.9

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

12.2

PASI 75

Comparison groups

80 mg Ixekizumab Q4W v 80 mg Ixekizumab Q4W/Q2W

Number of subjects included in analysis

616

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.118

Method

Regression, Logistic

Parameter type

Risk difference (RD)

Point estimate

4.6

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

10.8

Secondary: Percentage of Participants Achieving sPGA (0)

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End point title

Percentage of Participants Achieving sPGA (0) ^[3]

End point description

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). 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 analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.

End point type

Secondary

End point timeframe

Week 52

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	310	306	609
Units: Percentage of participants
number (not applicable)	44.8	48.7	60.1

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving PASI 90

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End point title

Percentage of Participants Achieving PASI 90 ^[4]

End point description

PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). All randomized participants analyzed according to the treatment to which they were assigned.

End point type

Secondary

End point timeframe

Week 52

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	310	306	609
Units: Percentage of participants
number (not applicable)	65.2	73.9	79.5

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving PASI 100

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End point title

Percentage of Participants Achieving PASI 100 ^[5]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	310	306	609
Units: Percentage of participants
number (not applicable)	43.5	49.3	59.7

No statistical analyses for this end point

Secondary: Change from Baseline in PASI

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End point title

Change from Baseline in PASI ^[6]

End point description

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	274	268	538
Units: units on a scale
least squares mean (standard error)	-18.34 ( 0.22 )	-18.95 ( 0.22 )	-19.41 ( 0.17 )

No statistical analyses for this end point

Secondary: Percent Improvement in PASI

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End point title

Percent Improvement in PASI ^[7]

End point description

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	274	268	538
Units: Percent change
least squares mean (standard error)	91.09 ( 0.89 )	94.24 ( 0.90 )	96.25 ( 0.71 )

No statistical analyses for this end point

Secondary: Mean Change from Baseline in Percent Body Surface Area (BSA) Involvement

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End point title

Mean Change from Baseline in Percent Body Surface Area (BSA) Involvement ^[8]

End point description

The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. All randomized participants analyzed according to the treatment to which they were assigned who had baseline and a post-baseline measurement for BSA affected by Psoriasis.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	274	268	538
Units: Percent Body Surface Affected
least squares mean (standard error)	-23.93 ( 0.34 )	-24.62 ( 0.34 )	-25.01 ( 0.27 )

No statistical analyses for this end point

Secondary: Mean Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Score

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End point title

Mean Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Score ^[9]

End point description

The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	156 ^[10]	148	314
Units: units on a scale
least squares mean (standard error)	-19.27 ( 0.81 )	-19.87 ( 0.83 )	-20.82 ( 0.62 )

Notes
[10] - All randomized participants who had baseline fingernail involvement and a post-baseline measurement.

No statistical analyses for this end point

Secondary: Mean Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Score

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End point title

Mean Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Score ^[11]

End point description

The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. All randomized participants analyzed according to the treatment to which they were assigned and had baseline scalp involvement and had a post-baseline measurement.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	252	245	477
Units: units on a scale
least squares mean (standard error)	-18.35 ( 0.31 )	-18.73 ( 0.31 )	-18.65 ( 0.24 )

No statistical analyses for this end point

Secondary: Mean Change from Baseline in Palmoplantar PASI (PPASI)

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End point title

Mean Change from Baseline in Palmoplantar PASI (PPASI) ^[12]

End point description

The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. All randomized participants analyzed according to the treatment to which they were assigned and had baseline palmoplantar Ps involvement and had post-baseline measurement.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	72	82	150
Units: units on a scale
least squares mean (standard error)	-9.55 ( 0.31 )	-9.37 ( 0.30 )	-9.00 ( 0.26 )

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 point Reduction from Baseline

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End point title

Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 point Reduction from Baseline ^[13]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	254	260	505
Units: Percentage of participants
number (not applicable)	74.0	72.3	77.2

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) total score of 0 and 1 (DLQI [0,1])

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End point title

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) total score of 0 and 1 (DLQI [0,1]) ^[14]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	310	306	609
Units: Percentage of participants
number (not applicable)	66.1	70.3	74.0

No statistical analyses for this end point

Secondary: Change from Baseline in DLQI Total Score

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End point title

Change from Baseline in DLQI Total Score ^[15]

End point description

The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline DLQI data.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	273	265	538
Units: units on a scale
least squares mean (standard error)	-9.70 ( 0.21 )	-9.97 ( 0.22 )	-10.23 ( 0.17 )

No statistical analyses for this end point

Secondary: Change from Baseline in Itch NRS score

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End point title

Change from Baseline in Itch NRS score ^[16]

End point description

The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline Itch NRS data.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	274	268	537
Units: units on a scale
least squares mean (standard error)	-4.90 ( 0.13 )	-5.15 ( 0.13 )	-5.33 ( 0.10 )

No statistical analyses for this end point

Secondary: Change from Baseline in Skin Pain Visual Analog Scale (VAS)

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End point title

Change from Baseline in Skin Pain Visual Analog Scale (VAS) ^[17]

End point description

The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline skin pain VAS data.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	271	262	532
Units: mm
least squares mean (standard error)	-35.50 ( 0.94 )	-36.77 ( 0.96 )	-38.07 ( 0.74 )

No statistical analyses for this end point

Secondary: Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS

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End point title

Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS ^[18]

End point description

EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post baseline EQ-5D-5L VAS data.

End point type

Secondary

End point timeframe

Baseline, Week 52

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	268	264	519
Units: mm
least squares mean (standard error)	11.93 ( 0.94 )	12.47 ( 0.95 )	14.42 ( 0.74 )

No statistical analyses for this end point

Secondary: Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab

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End point title

Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab

End point description

Trough concentrations at steady state of Ixekizumab were evaluated. All randomized participants analyzed according to treatment to which they were assigned with evaluable PK samples that met the definition of being a trough concentration.

End point type

Secondary

End point timeframe

Predose, Week 4, 12, 24, 36 and 52 Post dose

End point values	80 mg Ixekizumab Q4W continuous	80 mg Ixekizumab Q4W/Q2W No Step	80 mg Ixekizumab Q4W/Q2W Step up	80 mg Ixekizumab Q2W continuous
Number of subjects analysed	304	232	73	602
Units: microgram per milliliter (µg/mL)
geometric mean (geometric coefficient of variation)
Week 4	3.55 ( 76 )	4.03 ( 72 )	2.78 ( 67 )	7.87 ( 63 )
Week 12	2.72 ( 72 )	2.81 ( 80 )	1.95 ( 70 )	8.23 ( 56 )
Week 24	2.65 ( 73 )	2.71 ( 85 )	3.48 ( 78 )	7.89 ( 66 )
Week 36	2.83 ( 74 )	2.88 ( 73 )	5.76 ( 67 )	7.73 ( 76 )
Week 52	2.43 ( 79 )	2.77 ( 73 )	5.73 ( 68 )	6.96 ( 87 )

No statistical analyses for this end point

Secondary: Number of Participants with Anti-Ixekizumab Antibodies

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End point title

Number of Participants with Anti-Ixekizumab Antibodies ^[19]

End point description

Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. All randomized participants who received at least 1 dose of Ixekizumab and had evaluable anti-ixekizumab antibody measurement

End point type

Secondary

End point timeframe

Baseline through Week 52

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analysis was not planned for this endpoint as per the protocol or Statistical Analysis Plan or both.

End point values	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Number of subjects analysed	307	305	606
Units: participants
number (not applicable)	71	64	84

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All the AEs in the Blinded Treatment Dosing Period and Post-Treatment Period of the Study

Adverse event reporting additional description

I1F-MC-RHBP

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.0

Reporting group title

Ixekizumab 80 mg Q2W Blinded Treatment Period - Global Cohort

Reporting group description

Reporting group title

Ixekizumab 80mg Q4W/Q2W Blinded Treatment Period-Global Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q4W Blinded Treatment Period - Global Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q2W Post-Treatment Period - Global Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q4W/Q2W Post-Treatment Period - Global Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q4W Post-Treatment Period - Global Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q2W Blinded Treatment Period - ME2 Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q4W/Q2W Blinded Treatment Period - ME2 Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q4W Blinded Treatment Period - ME2 Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q2W Post-Treatment Period - ME2 Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q4W/Q2W Post-Treatment Period - ME2 Cohort

Reporting group description

Reporting group title

Ixekizumab 80 mg Q4W Post-Treatment Period - ME2 Cohort

Reporting group description

Ixekizumab 80 mg Q2W Blinded Treatment Period - Global Cohort

Ixekizumab 80mg Q4W/Q2W Blinded Treatment Period-Global Cohort

Ixekizumab 80 mg Q4W Blinded Treatment Period - Global Cohort

Ixekizumab 80 mg Q2W Post-Treatment Period - Global Cohort

Ixekizumab 80 mg Q4W/Q2W Post-Treatment Period - Global Cohort

Ixekizumab 80 mg Q4W Post-Treatment Period - Global Cohort

Ixekizumab 80 mg Q2W Blinded Treatment Period - ME2 Cohort

Ixekizumab 80 mg Q4W/Q2W Blinded Treatment Period - ME2 Cohort

Ixekizumab 80 mg Q4W Blinded Treatment Period - ME2 Cohort

Ixekizumab 80 mg Q2W Post-Treatment Period - ME2 Cohort

Ixekizumab 80 mg Q4W/Q2W Post-Treatment Period - ME2 Cohort

Ixekizumab 80 mg Q4W Post-Treatment Period - ME2 Cohort

Total subjects affected by serious adverse events

subjects affected / exposed

32 / 609 (5.25%)

16 / 306 (5.23%)

16 / 310 (5.16%)

7 / 559 (1.25%)

2 / 283 (0.71%)

1 / 285 (0.35%)

0 / 16 (0.00%)

1 / 5 (20.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

adenocarcinoma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

0 / 310 (0.00%)

1 / 559 (0.18%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

adenocarcinoma gastric

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

adenocarcinoma of colon

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

benign bone neoplasm

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

1 / 5 (20.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

breast cancer metastatic

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

1 / 283 (0.35%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

colon cancer

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

dermatofibrosarcoma protuberans

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

invasive breast carcinoma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

invasive ductal breast carcinoma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

neurilemmoma benign

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

plasma cell myeloma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

1 / 285 (0.35%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

deep vein thrombosis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pregnancy, puerperium and perinatal conditions

ectopic pregnancy

alternative dictionary used: MedDRA 20.0

subjects affected / exposed ^[1]

0 / 199 (0.00%)

0 / 107 (0.00%)

0 / 111 (0.00%)

1 / 184 (0.54%)

0 / 98 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

tubal rupture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed ^[2]

0 / 199 (0.00%)

0 / 107 (0.00%)

0 / 111 (0.00%)

1 / 184 (0.54%)

0 / 98 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

chest discomfort

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

non-cardiac chest pain

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

2 / 609 (0.33%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

vascular stent restenosis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

drug hypersensitivity

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

benign prostatic hyperplasia

alternative dictionary used: MedDRA 20.0

subjects affected / exposed ^[3]

0 / 410 (0.00%)

0 / 199 (0.00%)

1 / 199 (0.50%)

0 / 375 (0.00%)

0 / 185 (0.00%)

0 / 187 (0.00%)

0 / 12 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pulmonary microemboli

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

anxiety

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

depression

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

major depression

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

stress

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

suicide attempt

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

international normalised ratio increased

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

clavicle fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

fall

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

femur fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

hand fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

injury

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

joint dislocation

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

lower limb fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pelvic fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

0 / 310 (0.00%)

1 / 559 (0.18%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

rib fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

2 / 306 (0.65%)

0 / 310 (0.00%)

1 / 559 (0.18%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

road traffic accident

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

wound dehiscence

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

acute myocardial infarction

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 3

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

atrial fibrillation

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

cardiac failure

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

2 / 609 (0.33%)

0 / 306 (0.00%)

0 / 310 (0.00%)

1 / 559 (0.18%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

coronary artery disease

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

2 / 609 (0.33%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

myocardial infarction

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pericarditis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

basilar migraine

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

cerebrovascular accident

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

1 / 283 (0.35%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyposmia

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

transient ischaemic attack

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ear and labyrinth disorders

vertigo

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

retinal detachment

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

colitis ulcerative

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

crohn's disease

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

gastroenteritis eosinophilic

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

gastrointestinal haemorrhage

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

intra-abdominal haematoma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

oesophageal rupture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pancreatitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

umbilical hernia

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

cholecystitis acute

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

cholecystitis chronic

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

cholelithiasis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

0 / 310 (0.00%)

1 / 559 (0.18%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

dermatitis contact

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

psoriasis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

0 / 310 (0.00%)

1 / 559 (0.18%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

rash macular

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

stevens-johnson syndrome

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

0 / 310 (0.00%)

1 / 559 (0.18%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

renal haematoma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

urinary retention

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Endocrine disorders

goitre

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

cartilage hypertrophy

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

intervertebral disc compression

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

musculoskeletal chest pain

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

abscess limb

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

abscess oral

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

appendicitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

1 / 306 (0.33%)

0 / 310 (0.00%)

1 / 559 (0.18%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

carbuncle

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

1 / 306 (0.33%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

cellulitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

2 / 306 (0.65%)

2 / 310 (0.65%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 2

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

chronic sinusitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

chronic tonsillitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

gastroenteritis shigella

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pneumonia

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pyelonephritis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pyelonephritis acute

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

sepsis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

urosepsis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

diabetic ketoacidosis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

gout

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

0 / 310 (0.00%)

1 / 559 (0.18%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

hypokalaemia

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 609 (0.16%)

0 / 306 (0.00%)

0 / 310 (0.00%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

lactic acidosis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 609 (0.00%)

0 / 306 (0.00%)

1 / 310 (0.32%)

0 / 559 (0.00%)

0 / 283 (0.00%)

0 / 285 (0.00%)

0 / 16 (0.00%)

0 / 5 (0.00%)

0 / 9 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Ixekizumab 80 mg Q2W Blinded Treatment Period - Global Cohort	Ixekizumab 80mg Q4W/Q2W Blinded Treatment Period-Global Cohort	Ixekizumab 80 mg Q4W Blinded Treatment Period - Global Cohort	Ixekizumab 80 mg Q2W Post-Treatment Period - Global Cohort	Ixekizumab 80 mg Q4W/Q2W Post-Treatment Period - Global Cohort	Ixekizumab 80 mg Q4W Post-Treatment Period - Global Cohort	Ixekizumab 80 mg Q2W Blinded Treatment Period - ME2 Cohort	Ixekizumab 80 mg Q4W/Q2W Blinded Treatment Period - ME2 Cohort	Ixekizumab 80 mg Q4W Blinded Treatment Period - ME2 Cohort	Ixekizumab 80 mg Q2W Post-Treatment Period - ME2 Cohort	Ixekizumab 80 mg Q4W/Q2W Post-Treatment Period - ME2 Cohort	Ixekizumab 80 mg Q4W Post-Treatment Period - ME2 Cohort
Total subjects affected by non serious adverse events
subjects affected / exposed	285 / 609 (46.80%)	136 / 306 (44.44%)	157 / 310 (50.65%)	40 / 559 (7.16%)	20 / 283 (7.07%)	16 / 285 (5.61%)	11 / 16 (68.75%)	4 / 5 (80.00%)	6 / 9 (66.67%)	2 / 15 (13.33%)	0 / 4 (0.00%)	2 / 9 (22.22%)
Investigations
alanine aminotransferase increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 609 (0.49%)	2 / 306 (0.65%)	7 / 310 (2.26%)	0 / 559 (0.00%)	1 / 283 (0.35%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	3	2	7	0	1	0	0	0	1	0	0	0
aspartate aminotransferase increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 609 (0.49%)	2 / 306 (0.65%)	5 / 310 (1.61%)	0 / 559 (0.00%)	1 / 283 (0.35%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	3	2	5	0	1	0	0	0	1	0	0	0
blood glucose increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 609 (0.00%)	0 / 306 (0.00%)	0 / 310 (0.00%)	0 / 559 (0.00%)	1 / 283 (0.35%)	0 / 285 (0.00%)	0 / 16 (0.00%)	1 / 5 (20.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0	0	0	0
helicobacter test positive
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 609 (0.00%)	0 / 306 (0.00%)	0 / 310 (0.00%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
benign bone neoplasm
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 609 (0.00%)	0 / 306 (0.00%)	0 / 310 (0.00%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	0 / 16 (0.00%)	1 / 5 (20.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	9 / 609 (1.48%)	0 / 306 (0.00%)	1 / 310 (0.32%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	10	0	1	0	0	0	0	0	1	0	0	0
headache
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	29 / 609 (4.76%)	16 / 306 (5.23%)	14 / 310 (4.52%)	1 / 559 (0.18%)	1 / 283 (0.35%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	34	18	16	1	1	0	0	0	0	0	0	0
General disorders and administration site conditions
injection site erythema
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	18 / 609 (2.96%)	3 / 306 (0.98%)	4 / 310 (1.29%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	2 / 16 (12.50%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	49	4	14	0	0	0	24	0	0	0	0	0
injection site oedema
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 609 (0.16%)	0 / 306 (0.00%)	1 / 310 (0.32%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	2 / 16 (12.50%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	4	0	0	0	24	0	0	0	0	0
injection site pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	8 / 609 (1.31%)	6 / 306 (1.96%)	4 / 310 (1.29%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	26	7	4	0	0	0	1	0	0	0	0	0
injection site pruritus
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 609 (0.66%)	0 / 306 (0.00%)	1 / 310 (0.32%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	13	0	4	0	0	0	1	0	0	0	0	0
injection site reaction
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	49 / 609 (8.05%)	5 / 306 (1.63%)	18 / 310 (5.81%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	256	15	68	0	0	0	0	0	0	0	0	0
injection site swelling
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	7 / 609 (1.15%)	0 / 306 (0.00%)	2 / 310 (0.65%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	11	0	11	0	0	0	1	0	0	0	0	0
xerosis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 609 (0.16%)	2 / 306 (0.65%)	1 / 310 (0.32%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	2	1	0	0	0	1	0	0	0	0	0
Blood and lymphatic system disorders
neutropenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 609 (0.16%)	0 / 306 (0.00%)	2 / 310 (0.65%)	1 / 559 (0.18%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	2	0	2	1	0	0	1	0	0	0	0	0
Eye disorders
retinal vein occlusion
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 609 (0.00%)	0 / 306 (0.00%)	0 / 310 (0.00%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0
Gastrointestinal disorders
dry mouth
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 609 (0.33%)	2 / 306 (0.65%)	0 / 310 (0.00%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	2	2	0	0	0	0	1	0	0	0	0	0
dyspepsia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 609 (0.66%)	1 / 306 (0.33%)	2 / 310 (0.65%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	4	1	2	0	0	0	0	0	1	0	0	0
gastric ulcer
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 609 (0.00%)	0 / 306 (0.00%)	1 / 310 (0.32%)	1 / 559 (0.18%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	1	0	0	1	0	0	0	0	0
gastritis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 609 (0.66%)	1 / 306 (0.33%)	3 / 310 (0.97%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	4	1	3	0	0	0	1	0	0	0	0	0
mouth ulceration
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 609 (0.00%)	0 / 306 (0.00%)	0 / 310 (0.00%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
cough
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	23 / 609 (3.78%)	2 / 306 (0.65%)	11 / 310 (3.55%)	2 / 559 (0.36%)	1 / 283 (0.35%)	1 / 285 (0.35%)	0 / 16 (0.00%)	0 / 5 (0.00%)	0 / 9 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	25	3	11	2	1	1	0	0	0	1	0	0
dysphonia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 609 (0.00%)	0 / 306 (0.00%)	0 / 310 (0.00%)	1 / 559 (0.18%)	0 / 283 (0.00%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0	0
epistaxis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 609 (0.49%)	0 / 306 (0.00%)	1 / 310 (0.32%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	3	0	1	0	0	0	0	0	1	0	0	0
oropharyngeal pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	17 / 609 (2.79%)	5 / 306 (1.63%)	6 / 310 (1.94%)	1 / 559 (0.18%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	17	5	6	1	0	0	1	0	0	0	0	0
Skin and subcutaneous tissue disorders
dermal cyst
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 609 (0.33%)	1 / 306 (0.33%)	2 / 310 (0.65%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	2	1	2	0	0	0	1	0	0	0	0	0
dry skin
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 609 (0.16%)	1 / 306 (0.33%)	0 / 310 (0.00%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	1	0	0	0	0	1	0	0	0	0	0
dyshidrotic eczema
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 609 (0.33%)	1 / 306 (0.33%)	2 / 310 (0.65%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	2	1	2	0	0	0	1	0	0	0	0	0
eczema
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	11 / 609 (1.81%)	5 / 306 (1.63%)	6 / 310 (1.94%)	1 / 559 (0.18%)	0 / 283 (0.00%)	1 / 285 (0.35%)	0 / 16 (0.00%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	12	6	8	1	0	1	0	0	2	0	0	0
psoriasis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 609 (0.49%)	3 / 306 (0.98%)	4 / 310 (1.29%)	6 / 559 (1.07%)	5 / 283 (1.77%)	3 / 285 (1.05%)	0 / 16 (0.00%)	0 / 5 (0.00%)	0 / 9 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	1 / 9 (11.11%)
occurrences all number	3	3	4	7	5	4	0	0	0	1	0	1
rash
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 609 (0.66%)	3 / 306 (0.98%)	3 / 310 (0.97%)	3 / 559 (0.54%)	0 / 283 (0.00%)	0 / 285 (0.00%)	0 / 16 (0.00%)	1 / 5 (20.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	4	3	3	5	0	0	0	1	0	0	0	0
urticaria
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	6 / 609 (0.99%)	4 / 306 (1.31%)	3 / 310 (0.97%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	7	4	3	0	0	0	1	0	1	0	0	0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	25 / 609 (4.11%)	5 / 306 (1.63%)	7 / 310 (2.26%)	4 / 559 (0.72%)	1 / 283 (0.35%)	2 / 285 (0.70%)	1 / 16 (6.25%)	1 / 5 (20.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	29	5	8	4	1	3	1	1	0	0	0	0
myalgia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	6 / 609 (0.99%)	0 / 306 (0.00%)	2 / 310 (0.65%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	2 / 16 (12.50%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	6	0	2	0	0	0	2	0	0	0	0	0
osteoarthritis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 609 (0.66%)	2 / 306 (0.65%)	4 / 310 (1.29%)	0 / 559 (0.00%)	1 / 283 (0.35%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	4	2	4	0	1	0	0	0	1	0	0	0
periarthritis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 609 (0.00%)	0 / 306 (0.00%)	0 / 310 (0.00%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Infections and infestations
furuncle
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	5 / 609 (0.82%)	1 / 306 (0.33%)	3 / 310 (0.97%)	1 / 559 (0.18%)	0 / 283 (0.00%)	1 / 285 (0.35%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	5	1	3	1	0	1	1	0	0	0	0	0
hordeolum
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 609 (0.66%)	2 / 306 (0.65%)	4 / 310 (1.29%)	0 / 559 (0.00%)	1 / 283 (0.35%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	1 / 9 (11.11%)
occurrences all number	4	2	7	0	1	0	0	0	0	0	0	1
influenza
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	5 / 609 (0.82%)	9 / 306 (2.94%)	6 / 310 (1.94%)	1 / 559 (0.18%)	2 / 283 (0.71%)	1 / 285 (0.35%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	5	10	6	1	2	1	1	0	0	0	0	0
mumps
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 609 (0.00%)	0 / 306 (0.00%)	0 / 310 (0.00%)	0 / 559 (0.00%)	0 / 283 (0.00%)	0 / 285 (0.00%)	0 / 16 (0.00%)	1 / 5 (20.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
otitis externa
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	8 / 609 (1.31%)	3 / 306 (0.98%)	3 / 310 (0.97%)	1 / 559 (0.18%)	1 / 283 (0.35%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	8	4	4	1	1	0	1	0	0	0	0	0
tinea pedis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	8 / 609 (1.31%)	4 / 306 (1.31%)	6 / 310 (1.94%)	1 / 559 (0.18%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	10	4	6	1	0	0	1	0	0	0	0	0
tonsillitis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	6 / 609 (0.99%)	2 / 306 (0.65%)	1 / 310 (0.32%)	2 / 559 (0.36%)	0 / 283 (0.00%)	0 / 285 (0.00%)	1 / 16 (6.25%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	6	2	2	2	0	0	1	0	0	0	0	0
upper respiratory tract infection
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	69 / 609 (11.33%)	39 / 306 (12.75%)	46 / 310 (14.84%)	3 / 559 (0.54%)	3 / 283 (1.06%)	1 / 285 (0.35%)	1 / 16 (6.25%)	1 / 5 (20.00%)	2 / 9 (22.22%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	93	56	60	3	3	1	1	1	2	0	0	0
urinary tract infection
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	15 / 609 (2.46%)	4 / 306 (1.31%)	16 / 310 (5.16%)	6 / 559 (1.07%)	2 / 283 (0.71%)	0 / 285 (0.00%)	0 / 16 (0.00%)	0 / 5 (0.00%)	0 / 9 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	20	4	21	6	2	0	0	0	0	0	0	0
vaginal infection
alternative dictionary used: MedDRA 20.0
subjects affected / exposed ^[4]	0 / 199 (0.00%)	1 / 107 (0.93%)	0 / 111 (0.00%)	0 / 184 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 4 (25.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	0	0	0
viral upper respiratory tract infection
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	73 / 609 (11.99%)	53 / 306 (17.32%)	41 / 310 (13.23%)	9 / 559 (1.61%)	0 / 283 (0.00%)	6 / 285 (2.11%)	6 / 16 (37.50%)	1 / 5 (20.00%)	1 / 9 (11.11%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 9 (0.00%)
occurrences all number	89	69	49	9	0	7	9	1	1	0	0	0

Notes
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly..

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)

Primary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)

Primary: Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)

Primary: Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)

Secondary: Percentage of Participants Achieving sPGA (0)

Secondary: Percentage of Participants Achieving sPGA (0)

Secondary: Percentage of Participants Achieving PASI 90

Secondary: Percentage of Participants Achieving PASI 90

Secondary: Percentage of Participants Achieving PASI 100

Secondary: Percentage of Participants Achieving PASI 100

Secondary: Change from Baseline in PASI

Secondary: Change from Baseline in PASI

Secondary: Percent Improvement in PASI

Secondary: Percent Improvement in PASI

Secondary: Mean Change from Baseline in Percent Body Surface Area (BSA) Involvement

Secondary: Mean Change from Baseline in Percent Body Surface Area (BSA) Involvement

Secondary: Mean Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Score

Secondary: Mean Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Score

Secondary: Mean Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Score

Secondary: Mean Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Score

Secondary: Mean Change from Baseline in Palmoplantar PASI (PPASI)

Secondary: Mean Change from Baseline in Palmoplantar PASI (PPASI)

Secondary: Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 point Reduction from Baseline

Secondary: Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 point Reduction from Baseline

Secondary: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) total score of 0 and 1 (DLQI [0,1])

Secondary: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) total score of 0 and 1 (DLQI [0,1])

Secondary: Change from Baseline in DLQI Total Score

Secondary: Change from Baseline in DLQI Total Score

Secondary: Change from Baseline in Itch NRS score

Secondary: Change from Baseline in Itch NRS score

Secondary: Change from Baseline in Skin Pain Visual Analog Scale (VAS)

Secondary: Change from Baseline in Skin Pain Visual Analog Scale (VAS)

Secondary: Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS

Secondary: Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS

Secondary: Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab

Secondary: Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab

Secondary: Number of Participants with Anti-Ixekizumab Antibodies

Secondary: Number of Participants with Anti-Ixekizumab Antibodies

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis