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Clinical Trial Results:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Summary
EudraCT number	2019-002933-12
Trial protocol	DE BG IT
Global end of trial date	28 Apr 2022

Results information
Results version number	v2(current)
This version publication date	11 May 2023
First version publication date	27 Jul 2022
Other versions	v1
Version creation reason	New data added to full data set Full Data

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

J2T-DM-KGAC

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 17802

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 EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

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

Yes

EMA paediatric investigation plan number(s)

EMEA-002536-PIP01-18

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

28 Apr 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

28 Apr 2022

Was the trial ended prematurely?

Main objective of the trial

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

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

29 Oct 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 58

Country: Number of subjects enrolled

Singapore: 19

Country: Number of subjects enrolled

United States: 185

Country: Number of subjects enrolled

Taiwan: 60

Country: Number of subjects enrolled

Ukraine: 11

Country: Number of subjects enrolled

Mexico: 9

Country: Number of subjects enrolled

Bulgaria: 22

Country: Number of subjects enrolled

Germany: 81

Worldwide total number of subjects

445

EEA total number of subjects

103

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)

362

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants were randomly assigned to either 250 mg lebrikizumab Q2W or placebo; At week (Wk) 16, participants who responded to treatment, defined as having an IGA of 0 or 1 or a 75% reduction in EASI-75 from Baseline to Wk 16 entered Maintenance Period; were re-randomized (2:2:1) to: lebrikizumab 250 mg Q2W, lebrikizumab 250 mg Q4W, or placebo

Screening details

(Continued) Induction non-responder; participants who do not achieve IGA of 0 or 1 or EASI-75 at Week 16 and maintenance non-responders; those not maintaining an EASI-50 response at week 24, 32, 40, and 48 following week 16 re-randomization were assigned to Escape Arm received lebrikizumab 250 mg as open-label treatment Q2W through Week 52.

Period 1 title

Induction Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Induction - Placebo

Arm description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Two subcutaneous injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Induction - Lebrikizumab Q2W

Arm description

Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

Other name

LY3650150, DRM06

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received 250 mg of Lebrikizumab administered as subcutaneous injection.

Number of subjects in period 1	Induction - Placebo	Induction - Lebrikizumab Q2W
Started	150	295
Received at Least One Dose of Study Drug	149	295
Completed	133	273
Not completed	17	22
Consent withdrawn by subject	6	4
Participant Missed Study Visits	-	1
Adverse event, non-fatal	4	6
Due to Epidemic/Pandemic	1	4
Lost to follow-up	2	-
Lack of efficacy	4	1
Protocol deviation	-	6

Period 2 title

Maintenance Blinded Treatment Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Maintenance - Placebo Responder/Placebo

Arm description

Maintenance Secondary Population: Maintenance Period (Week 16 to Week 52): One SC injection of Placebo Q2W until Week 50. Two placebo SC injections as loading dose on Week 16 and Week 18.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received subcutaneous Injection of Placebo.

Maintenance - Placebo Responder/Lebrikizumab 250 Q4W

Arm description

Maintenance Secondary Population: Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48. One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50. For participants who received placebo in the Induction Period, the maintenance loading dose is: Two 250 mg Lebrikizumab SC injections on Week 16. Two placebo injections on Week 18.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

Other name

LY3650150, DRM06

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Two 250 mg Lebrikizumab SC injection as maintenance loading dose on Week 16 and two placebo SC injections on Week 18. One 250 mg Lebrikizumab SC injection Every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48. One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50.

Maintenance - Placebo Responder/Lebrikizumab 250 Q2W

Arm description

Maintenance Secondary Population: Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection Q2W until Week 50. For participants who received placebo in the Induction Period, the maintenance loading dose is: Two 250 mg Lebrikizumab SC injections on Week 16. Two 250 mg Lebrikizumab SC injections on Week 18.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

Other name

LY3650150, DRM06

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

250 mg Lebrikizumab SC injection Q2W.

Maintenance - Lebrikizumab Responder/Placebo

Arm description

Maintenance Primary Population: Maintenance Period (Week 16 to Week 52): One SC injection of Placebo Q2W until Week 50. Two placebo SC injections as loading dose on Week 16 and Week 18.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

One SC injection of Placebo Q2W.

Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W

Arm description

Maintenance Primary Population: Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48. One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50. To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is: One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. Two placebo injections on Week 18.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

Other name

LY3650150, DRM06

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and two placebo SC injections on Week 18. One 250 mg Lebrikizumab SC injection Every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48. One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50.

Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W

Arm description

Maintenance Primary Population: Maintenance Period (Week 16 to Week 52): One 250 mg Lebrikizumab SC injection Q2W until Week 50. To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is: One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

Other name

LY3650150, DRM06

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

250 mg Lebrikizumab SC injection Q2W.

Number of subjects in period 2 ^[1]	Maintenance - Placebo Responder/Placebo	Maintenance - Placebo Responder/Lebrikizumab 250 Q4W	Maintenance - Placebo Responder/Lebrikizumab 250 Q2W	Maintenance - Lebrikizumab Responder/Placebo	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W
Started	5	9	11	30	59	59
Received at Least One Dose of Study Drug	5	9	11	30	59	59
Completed	4	6	9	22	51	42
Not completed	1	3	2	8	8	17
Consent withdrawn by subject	-	-	1	2	-	4
Physician decision	-	-	-	-	1	-
Adverse event, non-fatal	-	-	-	1	2	1
Sponsor Decision	1	1	1	1	4	6
Entered Escape Arm	-	1	-	3	1	6
Lost to follow-up	-	1	-	-	-	-
Lack of efficacy	-	-	-	1	-	-

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Participants who responded to treatment, defined as and IGA of 0 or 1 or a 75% reduction in EASI from baseline to Week 16, entered the Maintenance Period and re-randomized to the following treatment groups: lebrikizumab 250 mg Q2W, lebrikizumab 250 mg Q4W, or placebo Q2W.

Period 3 title

Maintenance Open Label Escape Arm

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Escape Arm Wk 16 - Maintenance OL- PBO/Leb 250 Q2W

Arm description

Maintenance Escape Period (Week 16 to Week 52): Blinded loading doses based on prior treatment assignment will be administered, followed by one 250 mg Lebrikizumab SC injection Q2W until Week 50 in an open-label fashion. For participants who received placebo in the Induction Period, the loading dose is: Two 250 mg Lebrikizumab SC injection on Week 16. Two 250 mg Lebrikizumab SC injections on Week 18. For participants who do not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses will be administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm. Participants who did not achieve an EASI-50 response after 8 weeks in the Escape Arm were terminated from the study.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

Other name

LY3650150, DRM06

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

250 mg Lebrikizumab Q2W.

Escape Arm Wk 16 - Maintenance OL - Leb NR/Leb 250 Q2W

Arm description

Maintenance Escape Period (Week 16 to Week 52): Blinded loading doses based on prior treatment assignment will be administered, followed by one 250 mg Lebrikizumab SC injection Q2W until Week 50 in an open-label fashion. To maintain the loading dose blind, for participants who received Lebrikizumab in the Induction Period, the loading dose is: One 250 mg Lebrikizumab SC injection and one placebo on Week16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18. For participants who do not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses will be administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm. Participants who did not achieve an EASI-50 response after 8 weeks in the Escape Arm were terminated from the study.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

Other name

LY3650150, DRM06

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Maintenance Escape Period (Week 16 to Week 52): 250 mg Lebrikizumab SC injection Q2W.

Escape Arm Wk 24-48 - Maintenance OL - Leb 250 Q2W

Arm description

Escape Arm Week 24 to 48 - Maintenance Open Label Lebrikizumab 250 Q2W.

Arm type

Experimental

Investigational medicinal product name

Lebrikizumab

Investigational medicinal product code

Other name

LY3650150, DRM06

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Maintenance Escape Period (Week 24 to Week 48): 250 mg Lebrikizumab Q2W.

Number of subjects in period 3	Escape Arm Wk 16 - Maintenance OL- PBO/Leb 250 Q2W	Escape Arm Wk 16 - Maintenance OL - Leb NR/Leb 250 Q2W	Escape Arm Wk 24-48 - Maintenance OL - Leb 250 Q2W
Started	108	125	11
Received at Least One Dose of Study Drug	108	125	11
Completed	85	83	8
Not completed	23	42	3
Consent withdrawn by subject	4	9	1
Participant Missed Study Visits	-	1	-
Adverse event, non-fatal	3	3	-
Sponsor Decision	-	1	-
Lost to follow-up	-	1	-
Lack of efficacy	16	27	2

Baseline characteristics

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Reporting group title

Induction - Placebo

Reporting group description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Reporting group title

Induction - Lebrikizumab Q2W

Reporting group description

Reporting group values	Induction - Placebo	Induction - Lebrikizumab Q2W	Total
Number of subjects	150	295	445
Age categorical
Units: Subjects
<=18 years	17	33	50
Between 18 and 65 years	123	239	362
>=65 years	10	23	33
Gender categorical
Units: Subjects
Female	79	147	226
Male	71	148	219
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	2	3	5
Asian	44	78	122
Native Hawaiian or Other Pacific Islander	1	2	3
Black or African American	10	26	36
White	89	181	270
More than one race	3	4	7
Unknown or Not Reported	1	1	2
Region of Enrollment
Units: Subjects
Canada	16	42	58
Singapore	8	11	19
United States	64	121	185
Taiwan	21	39	60
Ukraine	3	8	11
Mexico	3	6	9
Bulgaria	7	15	22
Germany	28	53	81

End points

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Reporting group title

Induction - Placebo

Reporting group description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Reporting group title

Induction - Lebrikizumab Q2W

Reporting group description

Reporting group title

Maintenance - Placebo Responder/Placebo

Reporting group description

Maintenance Secondary Population: Maintenance Period (Week 16 to Week 52): One SC injection of Placebo Q2W until Week 50. Two placebo SC injections as loading dose on Week 16 and Week 18.

Reporting group title

Maintenance - Placebo Responder/Lebrikizumab 250 Q4W

Reporting group description

Reporting group title

Maintenance - Placebo Responder/Lebrikizumab 250 Q2W

Reporting group description

Reporting group title

Maintenance - Lebrikizumab Responder/Placebo

Reporting group description

Maintenance Primary Population: Maintenance Period (Week 16 to Week 52): One SC injection of Placebo Q2W until Week 50. Two placebo SC injections as loading dose on Week 16 and Week 18.

Reporting group title

Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W

Reporting group description

Reporting group title

Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W

Reporting group description

Reporting group title

Escape Arm Wk 16 - Maintenance OL- PBO/Leb 250 Q2W

Reporting group description

Reporting group title

Escape Arm Wk 16 - Maintenance OL - Leb NR/Leb 250 Q2W

Reporting group description

Maintenance Escape Period (Week 16 to Week 52): Blinded loading doses based on prior treatment assignment will be administered, followed by one 250 mg Lebrikizumab SC injection Q2W until Week 50 in an open-label fashion. To maintain the loading dose blind, for participants who received Lebrikizumab in the Induction Period, the loading dose is: One 250 mg Lebrikizumab SC injection and one placebo on Week16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18. For participants who do not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses will be administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm. Participants who did not achieve an EASI-50 response after 8 weeks in the Escape Arm were terminated from the study.

Reporting group title

Escape Arm Wk 24-48 - Maintenance OL - Leb 250 Q2W

Reporting group description

Escape Arm Week 24 to 48 - Maintenance Open Label Lebrikizumab 250 Q2W.

Subject analysis set title

Maintenance 250 mg Lebrikizumab Q4W

Subject analysis set type

Per protocol

Subject analysis set description

250 mg Lebrikizumab administered SC injection Q4W.

Subject analysis set title

Maintenance 250 mg Leb Q2W and 250 mg Leb escape Q2W

Subject analysis set type

Per protocol

Subject analysis set description

250 mg Lebrikizumab (Leb) administered SC injection Q2W.

Primary: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

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End point title

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to Good Clinical Practice (GCP) issues. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.

End point type

Primary

End point timeframe

Baseline to Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	10.8 (5.7 to 15.9)	33.2 (27.5 to 38.9)

Percentage of Participants With an Investigator G

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000004

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

21.9

Confidence interval

level

95%

sides

2-sided

lower limit

14.2

upper limit

29.6

Primary: Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

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End point title

Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

End point description

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Primary

End point timeframe

Baseline to Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	18.1 (11.7 to 24.5)	52.1 (46.1 to 58.0)

Percentage of Participants Achieving Eczema Area

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

33.3

Confidence interval

level

95%

sides

2-sided

lower limit

24.4

upper limit

42.2

Secondary: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 2

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End point title

Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 2

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 2

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	0 (0.0 to 0.0)	0.7 (-0.3 to 1.7)

Percentage of participants with an IGA score of 0

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.308463

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

1.7

Secondary: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 4

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End point title

Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 4

End point description

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	1.4 (0.0 to 3.3)	9.0 (5.6 to 12.4)

Percentage of participants with an IGA score of 0

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001607

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

8.1

Confidence interval

level

95%

sides

2-sided

lower limit

4.1

upper limit

Secondary: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16

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End point title

Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	10.8 (5.7 to 15.9)	33.2 (27.5 to 38.9)

Percentage of participants with an IGA score of 0

Comparison groups

Induction - Lebrikizumab Q2W v Induction - Placebo

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000004

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

21.9

Confidence interval

level

95%

sides

2-sided

lower limit

14.2

upper limit

29.6

Secondary: Percentage of participants achieving EASI-90 (≥90% reduction in EASI score) from Baseline to Week 16

Top of page

End point title

Percentage of participants achieving EASI-90 (≥90% reduction in EASI score) from Baseline to Week 16

End point description

The EASI assesses objective physician estimates of 2 dimensions of AD-disease extent and clinical signs affected: 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0=none, absent; 1=mild; 2=moderate; 3=severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	9.5 (4.6 to 14.3)	30.7 (25.2 to 36.2)

Percentage of participants achieving EASI-90 (≥90

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000008

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

20.7

Confidence interval

level

95%

sides

2-sided

lower limit

13.3

upper limit

28.1

Secondary: Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16

Top of page

End point title

Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis of covariance (ANCOVA) model with treatment and randomization strata (region, disease severity, age) as fixed factors and baseline value as covariate. All randomized participants, with a Baseline Pruritus NRS score >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage change
least squares mean (standard error)	-9.02 ( 3.868 )	-36.56 ( 3.321 )

Percentage change in Pruritus Numerical Rating Sc

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-27.53

Confidence interval

level

95%

sides

2-sided

lower limit

-34.9

upper limit

-20.2

Secondary: Percentage of participants with a Pruritus NRS score of ≥4-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16

Top of page

End point title

Percentage of participants with a Pruritus NRS score of ≥4-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All randomized participants, with a Baseline Pruritus NRS score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	134	253
Units: percentage of participants
number (confidence interval 95%)	11.5 (6 to 16.9)	39.8 (33.6 to 46.0)

Pruritus NRS score of ≥4-points

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

387

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

28.3

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

36.5

Secondary: Percentage of participants with a Pruritus NRS score of ≥5-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16

Top of page

End point title

Percentage of participants with a Pruritus NRS score of ≥5-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All randomized participants, with Baseline Pruritus NRS score ≥ 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	122	234
Units: percentage of participants
number (confidence interval 95%)	11.8 (6 to 17.6)	41.6 (35.1 to 48.1)

Pruritus NRS score of ≥5-points

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

356

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

29.7

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

38.4

Secondary: Percentage change in EASI score from Baseline to Week 16

Top of page

End point title

Percentage change in EASI score from Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percent change
least squares mean (standard error)	-27.96 ( 3.893 )	-61.53 ( 3.300 )

EASI score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-33.57

Confidence interval

level

95%

sides

2-sided

lower limit

-41.2

upper limit

-26

Secondary: Change From Baseline in Percent Body Surface Area (BSA) at Week 16

Top of page

End point title

Change From Baseline in Percent Body Surface Area (BSA) at Week 16

End point description

The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Percent of BSA for a body region was calculated as=total number of palms in a body region*% surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD. All randomized participants, with observed BSA data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	77	213
Units: percentage of BSA
least squares mean (standard error)	-14.0 ( 1.94 )	-30.2 ( 1.33 )

Percent BSA

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

290

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Mixed models analysis

Parameter type

LS Mean Difference (Final Values)

Point estimate

-16.2

Confidence interval

level

95%

sides

2-sided

lower limit

-20.3

upper limit

-12

Secondary: Percentage of participants achieving EASI-90 from Baseline to Week 4

Top of page

End point title

Percentage of participants achieving EASI-90 from Baseline to Week 4

End point description

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percentage of participants
number (confidence interval 95%)	1.5 (-0.5 to 3.5)	6.3 (3.4 to 9.2)

EASI-90

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.022921

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

4.9

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

8.4

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Top of page

End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

End point description

The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. A high score is indicative of a poor quality of life. All randomized participants, with non-missing baseline DLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	118	218
Units: score on a scale
least squares mean (standard error)	-2.4 ( 1.17 )	-7.3 ( 1.16 )

Dermatology Life Quality Index (DLQI)

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

336

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-4.9

Confidence interval

level

95%

sides

2-sided

lower limit

-6.3

upper limit

-3.5

Secondary: Percentage of participants achieving ≥4-point improvement in DLQI from Baseline to Week 16

Top of page

End point title

Percentage of participants achieving ≥4-point improvement in DLQI from Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	118	218
Units: percentage of participants
number (confidence interval 95%)	32.8 (24.1 to 41.4)	65.4 (59.0 to 71.9)

DLQI

Comparison groups

Induction - Lebrikizumab Q2W v Induction - Placebo

Number of subjects included in analysis

336

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

32.9

Confidence interval

level

95%

sides

2-sided

lower limit

22.2

upper limit

43.6

Secondary: Percentage of participants with a DLQI total score of ≥4-point at baseline achieving ≥4-point improvement in DLQI from baseline to Week 16

Top of page

End point title

Percentage of participants with a DLQI total score of ≥4-point at baseline achieving ≥4-point improvement in DLQI from baseline to Week 16

End point description

The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. A high score is indicative of a poor quality of life. All randomized participants, with a DLQI Total Score of ≥4-point at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	115	215
Units: percentage of participants
number (confidence interval 95%)	33.6 (24.8 to 42.5)	66.3 (59.9 to 72.8)

DLQI total score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

330

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

22.2

upper limit

43.8

Secondary: Percentage change in Sleep-loss score from Baseline to Week 16

Top of page

End point title

Percentage change in Sleep-loss score from Baseline to Week 16

End point description

Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. All randomized participants, with baseline sleep-loss score >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percent change
least squares mean (standard error)	-11.29 ( 5.393 )	-48.37 ( 4.590 )

Sleep-loss score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-37.09

Confidence interval

level

95%

sides

2-sided

lower limit

-47.4

upper limit

-26.8

Secondary: Change from Baseline in Sleep-loss score at Week 16

Top of page

End point title

Change from Baseline in Sleep-loss score at Week 16

End point description

Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. All randomized participants, with non-missing baseline Sleep-loss score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: score on a scale
least squares mean (standard error)	-0.35 ( 0.095 )	-1.05 ( 0.080 )

Sleep-loss score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.5

Secondary: Percentage of participants with a Sleep-loss score ≥2 points at Baseline who achieve a ≥2 points reduction from Baseline to Week 16

Top of page

End point title

Percentage of participants with a Sleep-loss score ≥2 points at Baseline who achieve a ≥2 points reduction from Baseline to Week 16

End point description

Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. All randomized participants, with baseline sleep-loss score ≥2 Points, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	97	161
Units: percentage of participants
number (confidence interval 95%)	8.2 (2.5 to 13.9)	28.0 (21.0 to 35.0)

Sleep-loss score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

258

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000571

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

18.9

Confidence interval

level

95%

sides

2-sided

lower limit

9.6

upper limit

28.1

Secondary: Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1

Top of page

End point title

Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All randomized participants, with a Pruritus NRS Score of ≥4 Points at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 1

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	134	253
Units: percentage of participants
number (confidence interval 95%)	0.0 (0.0 to 0.0)	0.4 (0.0 to 1.2)

Pruritus NRS score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

387

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.469221

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

1.2

Secondary: Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2

Top of page

End point title

Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All randomized participants, with a Pruritus NRS Score of ≥4 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 2

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	134	253
Units: percentage of participants
number (confidence interval 95%)	0.7 (0.0 to 2.2)	3.6 (1.3 to 5.9)

Pruritus NRS score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

387

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.113194

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

5.4

Secondary: Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4

Top of page

End point title

Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All randomized participants, with a Pruritus NRS Score of ≥4 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	134	253
Units: percentage of participants
number (confidence interval 95%)	3.0 (0.0 to 6.0)	16.8 (12.2 to 21.4)

Pruritus NRS score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

387

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.00023

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

13.2

Confidence interval

level

95%

sides

2-sided

lower limit

7.7

upper limit

18.7

Secondary: Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1

Top of page

End point title

Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 1

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	122	234
Units: percentage of participants
number (confidence interval 95%)	0.0 (0.0 to 0.0)	0.4 (0.0 to 1.3)

Pruritus NRS score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

356

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.46816

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

1.3

Secondary: Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2

Top of page

End point title

Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 2

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	122	234
Units: percentage of participants
number (confidence interval 95%)	0.8 (0.0 to 2.4)	3.9 (1.4 to 6.3)

Pruritus NRS score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

356

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.11577

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

5.8

Secondary: Percentage Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16

Top of page

End point title

Percentage Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16

End point description

SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. All randomized participants, with baseline SCORAD >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: percent change
least squares mean (standard error)	-13.81 ( 3.197 )	-44.57 ( 2.677 )

SCORing Atopic Dermatitis (SCORAD)

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-30.76

Confidence interval

level

95%

sides

2-sided

lower limit

-36.93

upper limit

-24.59

Secondary: Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)

Top of page

End point title

Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)

End point description

C-trough was the concentration of study drug in the blood immediately before the next dose was administered. Trough serum concentration of Lebrikizumab was assessed at predose week 52. All participants who received 250 mg Q2W or 250 mg Q4W in the Maintenance Period and had evaluable PK data at Week 52. The 250 mg Q2W PK population also includes participants from the Escape Arm (Induction period non-responders and Maintenance Period non-responders who received open-label 250 mg Q2W dosing).

End point type

Secondary

End point timeframe

Predose at Week 52

End point values	Maintenance 250 mg Lebrikizumab Q4W	Maintenance 250 mg Leb Q2W and 250 mg Leb escape Q2W
Number of subjects analysed	51	206
Units: micrograms/milliliter (µg/mL)
arithmetic mean (standard deviation)	46.7 ( 24.8 )	90.5 ( 40.1 )

No statistical analyses for this end point

Secondary: Percentage of participants from those re-randomized having achieved EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-75 calculated relative to baseline EASI score)

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End point title

Percentage of participants from those re-randomized having achieved EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-75 calculated relative to baseline EASI score)

End point description

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit and re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during the maintenance period and had evaluable EASI-75 data at week 52.

End point type

Secondary

End point timeframe

Baseline to Week 52

End point values	Maintenance - Lebrikizumab Responder/Placebo	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W
Number of subjects analysed	27	53	51
Units: percentage of participants
number (confidence interval 95%)	72.0 (53.0 to 91.0)	84.7 (73.0 to 96.4)	77.4 (65.4 to 89.4)

EASI-75

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.238245

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

12.8

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

35.1

EASI-75

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.612427

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

4.8

Confidence interval

level

95%

sides

2-sided

lower limit

-17.8

upper limit

27.3

Secondary: Percentage of participants from those re-randomized having achieved IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 16 who continue to exhibit an IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 52

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End point title

Percentage of participants from those re-randomized having achieved IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 16 who continue to exhibit an IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 52

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit and re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during the maintenance period and had evaluable IGA data at week 52.

End point type

Secondary

End point timeframe

Baseline to Week 52

End point values	Maintenance - Lebrikizumab Responder/Placebo	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W
Number of subjects analysed	16	32	32
Units: percentage of participants
number (confidence interval 95%)	49.8 (23.7 to 75.8)	80.6 (65.9 to 95.3)	64.6 (47.2 to 82.0)

IGA score of 0 or 1

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.033876

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

32.6

Confidence interval

level

95%

sides

2-sided

lower limit

2.6

upper limit

62.5

IGA score of 0 or 1

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.407417

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

13.4

Confidence interval

level

95%

sides

2-sided

lower limit

-17.5

upper limit

44.3

Secondary: Percentage of participants from those with a Pruritus NRS of ≥4-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52

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End point title

Percentage of participants from those with a Pruritus NRS of ≥4-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit and re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during the maintenance period and had evaluable data at week 52.

End point type

Secondary

End point timeframe

Baseline to Week 52

End point values	Maintenance - Lebrikizumab Responder/Placebo	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W
Number of subjects analysed	11	36	23
Units: percentage of participants
number (confidence interval 95%)	67.6 (38.6 to 96.7)	88.1 (77.1 to 99.1)	90.3 (77.3 to 103.2)

Pruritus NRS

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.159281

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

20.3

Confidence interval

level

95%

sides

2-sided

lower limit

-11.4

upper limit

Pruritus NRS

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.16495

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

20.4

Confidence interval

level

95%

sides

2-sided

lower limit

-10.6

upper limit

51.4

Secondary: Percentage of participants from those with a Pruritus NRS of ≥5-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52

Top of page

End point title

Percentage of participants from those with a Pruritus NRS of ≥5-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit and re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during the maintenance period and had evaluable data at week 52.

End point type

Secondary

End point timeframe

Baseline to Week 52

End point values	Maintenance - Lebrikizumab Responder/Placebo	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W
Number of subjects analysed	11	34	22
Units: percentage of partcipants
number (confidence interval 95%)	67.6 (38.6 to 96.7)	87.4 (75.8 to 99.0)	94.4 (83.6 to 105.1)

Pruritus NRS

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.179704

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

19.7

Confidence interval

level

95%

sides

2-sided

lower limit

-12.2

upper limit

51.2

Pruritus NRS

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.08308

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

24.3

Confidence interval

level

95%

sides

2-sided

lower limit

-6.5

upper limit

55.1

Secondary: Percentage change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) from baseline at Week 52

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End point title

Percentage change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) from baseline at Week 52

End point description

SCORAD assesses the extent and intensity of AD, it consists of 3 components: A=extent of AD as percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on VAS, where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. All participants who were randomized to Lebrikizumab 250 mg Q2W at Baseline Visit, re-randomized to Lebrikizumab 250 mg Q2W, Lebrikizumab 250 mg Q4W or placebo at Week 16 and received at least 1 dose of study treatment during maintenance period, had data at week 52.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Maintenance - Lebrikizumab Responder/Placebo	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W
Number of subjects analysed	27	53	51
Units: percent change
least squares mean (standard error)	-67.60 ( 3.767 )	-73.89 ( 2.718 )	-73.85 ( 2.764 )

SCORing Atopic Dermatitis (SCORAD)

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.176748

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-6.29

Confidence interval

level

95%

sides

2-sided

lower limit

-15.46

upper limit

2.87

SCORing Atopic Dermatitis (SCORAD)

Comparison groups

Maintenance - Lebrikizumab Responder/Placebo v Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.183151

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-6.25

Confidence interval

level

95%

sides

2-sided

lower limit

-15.48

upper limit

2.99

Secondary: Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

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End point title

Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

End point description

The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a is a 2-part questionnaire which measure health status of the participant. The first component (Health state) is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. All randomized participants, with non-missing EQ-5D-5L- Health State Index data at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	146	281
Units: score on a scale
least squares mean (standard error)
Health State Index UK	0.0 ( 0.02 )	0.1 ( 0.02 )
Health State Index US	0.0 ( 0.01 )	0.1 ( 0.01 )

EQ-5D-5L

Statistical analysis description

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

0.1

Notes
[1] - UK

EQ-5D-5L

Statistical analysis description

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

427

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

= 0.000001

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.1

Notes
[2] - US

Secondary: Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

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End point title

Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

End point description

The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. All randomized participants, with non-missing EQ-5D-5L-VAS data at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	145	277
Units: millimeters (mm)
least squares mean (standard error)	5.2 ( 1.62 )	9.7 ( 1.36 )

EQ-5D-5L-VAS

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

422

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005304

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

4.5

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

7.6

Secondary: Change from Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

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End point title

Change from Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

End point description

POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. All randomized participants, with observed POEM data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MMRM was used to handle all missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	65	184
Units: score on a scale
least squares mean (standard error)	-3.5 ( 0.77 )	-9.5 ( 0.52 )

Patient Oriented Eczema Measure (POEM)

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

249

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.000001

Method

Mixed models analysis

Parameter type

LS Mean Difference (Final Values)

Point estimate

-6

Confidence interval

level

95%

sides

2-sided

lower limit

-7.7

upper limit

-4.3

Secondary: Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents

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End point title

Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents

End point description

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. All randomized, adolescent participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	17	30
Units: T-score
least squares mean (standard error)	0.12 ( 2.129 )	-2.79 ( 1.550 )

PROMIS

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.241275

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-2.91

Confidence interval

level

95%

sides

2-sided

lower limit

-7.85

upper limit

2.03

Secondary: Change From Baseline in PROMIS Anxiety at Week 16 - Adults

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End point title

Change From Baseline in PROMIS Anxiety at Week 16 - Adults

End point description

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. All randomized, adults participants, with Week 16 PROMIS anxiety data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing Values were imputed using LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	128	246
Units: T-score
least squares mean (standard error)	-0.45 ( 0.580 )	-3.18 ( 0.422 )

PROMIS

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

374

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000116

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-2.74

Confidence interval

level

95%

sides

2-sided

lower limit

-4.12

upper limit

-1.36

Secondary: Change from Baseline in PROMIS Depression at Week 16- Adolescents

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End point title

Change from Baseline in PROMIS Depression at Week 16- Adolescents

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	17	30
Units: T-score
least squares mean (standard error)	-0.57 ( 2.047 )	-1.67 ( 1.493 )

PROMIS Depression

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.645132

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-5.86

upper limit

3.67

Secondary: Change From Baseline in PROMIS Depression at Week 16- Adults

Top of page

End point title

Change From Baseline in PROMIS Depression at Week 16- Adults

End point description

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. All randomized, adult participants, with Week 16 PROMIS Depression data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	128	246
Units: T-score
least squares mean (standard error)	0.16 ( 0.540 )	-2.59 ( 0.392 )

PROMIS Depression

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

374

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000031

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

-2.75

Confidence interval

level

95%

sides

2-sided

lower limit

-4.03

upper limit

-1.47

Secondary: Change from Baseline in Asthma Control Questionnaire (ACQ-5) score at Week 16 in participants who have self-reported comorbid asthma

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End point title

Change from Baseline in Asthma Control Questionnaire (ACQ-5) score at Week 16 in participants who have self-reported comorbid asthma

End point description

The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicate lower asthma control. All randomized participants, with non-missing baseline ACQ-5 score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	35	75
Units: score on a scale
least squares mean (standard error)	0.19 ( 0.140 )	0.19 ( 0.108 )

Asthma Control Questionnaire (ACQ-5) Score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

110

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.974417

Method

ANCOVA

Parameter type

LS Mean Difference (Final Values)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.27

upper limit

0.26

Secondary: Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

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End point title

Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

End point description

The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment). All randomized, adolescent participants, with non-missing baseline CDLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MMRM was used to handle all missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	5	17
Units: score on a scale
least squares mean (standard error)	-3.4 ( 2.10 )	-7.6 ( 1.13 )

CDLQI

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.084769

Method

Mixed models analysis

Parameter type

LS Mean Difference (Final Values)

Point estimate

-4.2

Confidence interval

level

95%

sides

2-sided

lower limit

-9.1

upper limit

0.6

Secondary: Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

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End point title

Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

End point description

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable". All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

End point type

Secondary

End point timeframe

Baseline to Week 4

End point values	Induction - Placebo	Induction - Lebrikizumab Q2W
Number of subjects analysed	122	234
Units: percentage of participants
number (confidence interval 95%)	3.3 (0.1 to 6.6)	18.1 (13.2 to 23.1)

Pruritus NRS score

Comparison groups

Induction - Placebo v Induction - Lebrikizumab Q2W

Number of subjects included in analysis

356

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.000252

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

14.2

Confidence interval

level

95%

sides

2-sided

lower limit

8.2

upper limit

20.1

Adverse events

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Timeframe for reporting adverse events

Baseline up to Week 52

Adverse event reporting additional description

All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Maintenance - Lebrikizumab Responder/Placebo

Reporting group description

Maintenance Primary Population: Maintenance Period (Week 16 to Week 52): One SC injection of Placebo Q2W until Week 50. Two placebo SC injections as loading dose on Week 16 and Week 18.

Reporting group title

Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W

Reporting group description

Reporting group title

Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W

Reporting group description

Reporting group title

Induction - Lebrikizumab Q2W

Reporting group description

Reporting group title

Maintenance - Placebo Responder/ Placebo

Reporting group description

Maintenance Secondary Population: Maintenance Period (Week 16 to Week 52): One SC injection of Placebo Q2W until Week 50. Two placebo SC injections as loading dose on Week 16 and Week 18.

Reporting group title

Induction - Placebo

Reporting group description

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Reporting group title

Maintenance - Placebo Responder/Lebrikizumab 250 Q2W

Reporting group description

Reporting group title

Escape Arm Wk 16 - Maintenance OL- PBO/Leb 250 Q2W

Reporting group description

Reporting group title

Escape Arm Wk 16 - Maintenance OL - Leb NR/Leb 250 Q2W

Reporting group description

Maintenance Escape Period (Week 16 to Week 52): Blinded loading doses based on prior treatment assignment will be administered, followed by one 250 mg Lebrikizumab SC injection Q2W until Week 50 in an open-label fashion. To maintain the loading dose blind, for participants who received Lebrikizumab in the Induction Period, the loading dose is: One 250 mg Lebrikizumab SC injection and one placebo on Week16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18. For participants who do not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses will be administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm. Participants who did not achieve an EASI-50 response after 8 weeks in the Escape Arm were terminated from the study.

Reporting group title

Escape Arm Wk 24-48 - Maintenance OL - Leb 250 Q2W

Reporting group description

Escape Arm Week 24 to 48 - Maintenance Open Label Lebrikizumab 250 Q2W.

Reporting group title

Maintenance - Placebo Responder/Lebrikizumab Q4W

Reporting group description

Serious adverse events	Maintenance - Lebrikizumab Responder/Placebo	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W	Induction - Lebrikizumab Q2W	Maintenance - Placebo Responder/ Placebo	Induction - Placebo	Maintenance - Placebo Responder/Lebrikizumab 250 Q2W	Escape Arm Wk 16 - Maintenance OL- PBO/Leb 250 Q2W	Escape Arm Wk 16 - Maintenance OL - Leb NR/Leb 250 Q2W	Escape Arm Wk 24-48 - Maintenance OL - Leb 250 Q2W	Maintenance - Placebo Responder/Lebrikizumab Q4W
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	2 / 59 (3.39%)	2 / 295 (0.68%)	0 / 5 (0.00%)	4 / 149 (2.68%)	0 / 11 (0.00%)	1 / 108 (0.93%)	5 / 125 (4.00%)	0 / 11 (0.00%)	2 / 9 (22.22%)
number of deaths (all causes)	0	0	0	0	0	1	0	0	1	0	0
number of deaths resulting from adverse events	0	0	0	0	0	1	0	0	1	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastases to bone
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
metastases to liver
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
pancreatic carcinoma metastatic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
uterine leiomyoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[1]	0 / 15 (0.00%)	0 / 34 (0.00%)	0 / 33 (0.00%)	0 / 147 (0.00%)	0 / 3 (0.00%)	1 / 78 (1.28%)	0 / 6 (0.00%)	0 / 54 (0.00%)	0 / 55 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
fibula fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
humerus fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
multiple injuries
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
paternal exposure during pregnancy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ulna fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
tibia fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
cardiac failure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
myocardial infarction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
cerebellar syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
rhegmatogenous retinal detachment
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
pancreatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
hepatic steatosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
dermatitis atopic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	2 / 125 (1.60%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
ureterolithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
spinal osteoarthritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
acarodermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
erysipelas
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
large intestine infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Maintenance - Lebrikizumab Responder/Placebo	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q4W	Maintenance - Lebrikizumab Responder/Lebrikizumab 250 Q2W	Induction - Lebrikizumab Q2W	Maintenance - Placebo Responder/ Placebo	Induction - Placebo	Maintenance - Placebo Responder/Lebrikizumab 250 Q2W	Escape Arm Wk 16 - Maintenance OL- PBO/Leb 250 Q2W	Escape Arm Wk 16 - Maintenance OL - Leb NR/Leb 250 Q2W	Escape Arm Wk 24-48 - Maintenance OL - Leb 250 Q2W	Maintenance - Placebo Responder/Lebrikizumab Q4W
Total subjects affected by non serious adverse events
subjects affected / exposed	15 / 30 (50.00%)	32 / 59 (54.24%)	36 / 59 (61.02%)	157 / 295 (53.22%)	3 / 5 (60.00%)	97 / 149 (65.10%)	8 / 11 (72.73%)	68 / 108 (62.96%)	77 / 125 (61.60%)	5 / 11 (45.45%)	4 / 9 (44.44%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bowen's disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	3	0	0
fibroadenoma of breast
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
ovarian germ cell teratoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[2]	0 / 15 (0.00%)	0 / 34 (0.00%)	0 / 33 (0.00%)	0 / 147 (0.00%)	0 / 3 (0.00%)	0 / 78 (0.00%)	0 / 6 (0.00%)	1 / 54 (1.85%)	0 / 55 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
skin papilloma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 295 (1.02%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	3	0	0	0	1	1	0	0
squamous cell carcinoma of skin
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0
squamous cell carcinoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
Vascular disorders
aortic arteriosclerosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
haematoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
hot flush
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
hypertension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	0 / 108 (0.00%)	3 / 125 (2.40%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	1	0	0	2	0	2	0	0	3	0	1
hypotension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
peripheral arterial occlusive disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
thrombophlebitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
General disorders and administration site conditions
chest discomfort
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
chills
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
cyst rupture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
fatigue
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 295 (1.02%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	0 / 108 (0.00%)	3 / 125 (2.40%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	3	0	2	0	0	3	0	1
injection site erythema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0
injection site discomfort
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
injection site haematoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
injection site pruritus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
injection site pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	3	0	1	0	0	0	0	0
injection site reaction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	4	0	0	0	1	0	0	0
injection site swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	1	0	0
injection site urticaria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
malaise
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	0
nodule
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
oedema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
oedema peripheral
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0
peripheral swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
pyrexia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0
swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
vaccination site pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	2 / 59 (3.39%)	2 / 59 (3.39%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	3	2	1	0	0	0	1	1	0	0
vaccination site reaction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0
Immune system disorders
allergy to animal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
allergy to arthropod sting
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
drug hypersensitivity
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
food allergy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	2 / 59 (3.39%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	2	1	0	0	0	0	0	0	0	0
hypersensitivity
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0
sarcoidosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
seasonal allergy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	3 / 295 (1.02%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	4	0	1	0	1	0	0	0
Reproductive system and breast disorders
adenomyosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[3]	0 / 15 (0.00%)	1 / 34 (2.94%)	0 / 33 (0.00%)	0 / 147 (0.00%)	0 / 3 (0.00%)	0 / 78 (0.00%)	0 / 6 (0.00%)	0 / 54 (0.00%)	0 / 55 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0
bartholin's cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[4]	0 / 15 (0.00%)	0 / 34 (0.00%)	0 / 33 (0.00%)	0 / 147 (0.00%)	0 / 3 (0.00%)	0 / 78 (0.00%)	0 / 6 (0.00%)	1 / 54 (1.85%)	0 / 55 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
breast hyperplasia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
breast ulceration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
heavy menstrual bleeding
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[5]	0 / 15 (0.00%)	0 / 34 (0.00%)	0 / 33 (0.00%)	0 / 147 (0.00%)	0 / 3 (0.00%)	1 / 78 (1.28%)	0 / 6 (0.00%)	0 / 54 (0.00%)	0 / 55 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
ovarian cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[6]	0 / 15 (0.00%)	1 / 34 (2.94%)	0 / 33 (0.00%)	0 / 147 (0.00%)	0 / 3 (0.00%)	0 / 78 (0.00%)	0 / 6 (0.00%)	0 / 54 (0.00%)	0 / 55 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
penis disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[7]	0 / 15 (0.00%)	0 / 25 (0.00%)	0 / 26 (0.00%)	0 / 148 (0.00%)	0 / 2 (0.00%)	0 / 71 (0.00%)	0 / 5 (0.00%)	0 / 54 (0.00%)	1 / 70 (1.43%)	0 / 8 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
polycystic ovaries
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[8]	0 / 15 (0.00%)	0 / 34 (0.00%)	1 / 33 (3.03%)	0 / 147 (0.00%)	0 / 3 (0.00%)	0 / 78 (0.00%)	0 / 6 (0.00%)	0 / 54 (0.00%)	0 / 55 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
vulvovaginal dryness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[9]	0 / 15 (0.00%)	0 / 34 (0.00%)	0 / 33 (0.00%)	1 / 147 (0.68%)	0 / 3 (0.00%)	0 / 78 (0.00%)	0 / 6 (0.00%)	0 / 54 (0.00%)	0 / 55 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
allergic sinusitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
asthma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	2 / 11 (18.18%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	0	0	0	1	1	2	0
cough
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	2	0	0	0	1	0	0	0
dyspnoea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
haemoptysis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
nasal congestion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	1	0	0	0
nasal polyps
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
nasal septum deviation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
oropharyngeal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 295 (0.68%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	2	0	1	0	0	1	0	0
rhinitis allergic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	4 / 295 (1.36%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	4	0	1	0	1	2	0	0
rhinorrhoea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
sinus congestion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
sleep apnoea syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0
throat tightness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
upper respiratory tract inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 30 (6.67%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	3 / 149 (2.01%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	2	1	0	0	0	3	0	0	0	0	0
depressed mood
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
depression
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
insomnia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	0	2	0	1	1	0	0
middle insomnia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
mood swings
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0
panic attack
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
restlessness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
sleep disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
sleep disorder due to general medical condition, insomnia type
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Investigations
alanine aminotransferase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	1	0	0	0	0	1	1	0	0
aspartate aminotransferase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0
blood bicarbonate decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	1	0	0
blood lactate dehydrogenase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1
blood glucose decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
blood cholesterol increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
blood phosphorus increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
blood alkaline phosphatase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0
blood alkaline phosphatase abnormal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
blood uric acid increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
blood testosterone decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0
blood pressure increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	1	0	0
blood pressure diastolic increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
electrocardiogram abnormal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	1 / 11 (9.09%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
eosinophil count increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	2	0	0	0	1	0	0	1
gamma-glutamyltransferase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	1 / 11 (9.09%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	1	0	0
hepatic enzyme increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
lymphocyte percentage decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
mean cell haemoglobin concentration decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
mean cell volume increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
neutrophil count increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
neutrophil count decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
platelet count increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	1	0	2	0	0	0	0	1
prostatic specific antigen increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[10]	0 / 15 (0.00%)	0 / 25 (0.00%)	0 / 26 (0.00%)	0 / 148 (0.00%)	0 / 2 (0.00%)	0 / 71 (0.00%)	0 / 5 (0.00%)	1 / 54 (1.85%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
urine ketone body present
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
weight decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0
weight increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	0	0	0
white blood cell count increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0
Injury, poisoning and procedural complications
accident at work
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
ankle fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
animal bite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
arthropod bite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
bone contusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
concussion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
clavicle fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
corneal abrasion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
contusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	1	0	0
epicondylitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
face injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
fall
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0
fibula fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
hand fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0
injury corneal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
joint dislocation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	2 / 108 (1.85%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	2	0	0	0
ligament sprain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	1	0	0	1	0	1	0	0	0
limb injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	0
lip injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
muscle strain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
neck injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	1 / 5 (20.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
overdose
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 295 (1.02%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	4	0	1	0	1	0	0	0
procedural headache
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
post procedural complication
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	0
procedural pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	2	0	0	2	0	0	0	0	0
skin abrasion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	1	0	0
skin laceration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
stress fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
thermal burn
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
tendon rupture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
tibia fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
vaccination complication
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 30 (6.67%)	2 / 59 (3.39%)	4 / 59 (6.78%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	1 / 11 (9.09%)	2 / 108 (1.85%)	2 / 125 (1.60%)	1 / 11 (9.09%)	0 / 9 (0.00%)
occurrences all number	2	2	7	3	0	0	1	3	2	1	0
wound dehiscence
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
wrist fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Cardiac disorders
angina pectoris
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
atrial fibrillation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
sinus bradycardia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
tachycardia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	1	0	0
Nervous system disorders
burning sensation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
cerebellar syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0
carpal tunnel syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
dizziness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	4 / 295 (1.36%)	0 / 5 (0.00%)	0 / 149 (0.00%)	1 / 11 (9.09%)	2 / 108 (1.85%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	4	0	0	1	2	0	0	0
headache
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	3 / 59 (5.08%)	2 / 59 (3.39%)	15 / 295 (5.08%)	1 / 5 (20.00%)	8 / 149 (5.37%)	0 / 11 (0.00%)	3 / 108 (2.78%)	1 / 125 (0.80%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	2	3	2	17	1	8	0	3	1	0	1
hyperaesthesia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0
hypoaesthesia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	2	0	0	0	0	0
narcolepsy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
neuralgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
paraesthesia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	1	0	0
presyncope
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
sciatica
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
syncope
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
tremor
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0	0
eosinophilia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	2	0	0
hypochromic anaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
iron deficiency anaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
lymphadenitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0
lymphadenopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0
lymphopenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
lymphocytosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0
thrombocytosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Ear and labyrinth disorders
auricular pseudocyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
ear discomfort
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0
ear pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0
paraesthesia ear
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
tinnitus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
vertigo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	2	0	0
Eye disorders
atopic keratoconjunctivitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	3	0	0	0	0	0	0	0
blepharitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	3	0	1	0	0	1	0	0
cataract
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	1	0	2	0	0	0	0	0
conjunctivitis allergic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	4 / 59 (6.78%)	1 / 59 (1.69%)	7 / 295 (2.37%)	0 / 5 (0.00%)	2 / 149 (1.34%)	1 / 11 (9.09%)	12 / 108 (11.11%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	6	1	7	0	2	1	14	1	0	0
dark circles under eyes
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
dry eye
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	1 / 59 (1.69%)	7 / 295 (2.37%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	3 / 108 (2.78%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	1	8	0	0	0	3	1	0	0
epiretinal membrane
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
episcleritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
eye discharge
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0
eye irritation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
eye pruritus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	1 / 11 (9.09%)	2 / 108 (1.85%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	0	0	1	2	1	0	0
eye swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
eyelid cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
eyelid erosion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0
keratitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	1	0	0
keratoconus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0
lacrimation increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	0
ocular hyperaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	1 / 11 (9.09%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0
retinopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
vision blurred
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	1
vitreous detachment
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
vitreous floaters
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	2 / 108 (1.85%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	0	0	0	3	0	0	0
abdominal pain upper
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
abdominal pain lower
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
angular cheilitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
breath odour
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
constipation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	2 / 108 (1.85%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	2	1	0	0
dental caries
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	2 / 125 (1.60%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	2
diarrhoea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	1	0	0	2	0	1	0	0	0	0	1
dyspepsia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	0	1	0	1	0	0	0
epiploic appendagitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
flatulence
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
gastritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
food poisoning
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0	0
gastrointestinal disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0	0	0
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
gastrointestinal inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
haematemesis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
haemorrhoids
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	2	0	1	0	1	0	0	1	0	0
hiatus hernia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
inguinal hernia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
irritable bowel syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	1 / 11 (9.09%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
nausea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	4 / 295 (1.36%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	4	0	1	0	1	1	0	0
oral mucosal eruption
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
peptic ulcer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	1 / 11 (9.09%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
toothache
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2
vomiting
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	1	0	0
Hepatobiliary disorders
biliary colic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
cholelithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
hepatic steatosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
acne
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	2 / 59 (3.39%)	1 / 59 (1.69%)	1 / 295 (0.34%)	0 / 5 (0.00%)	3 / 149 (2.01%)	1 / 11 (9.09%)	3 / 108 (2.78%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	2	1	1	0	3	1	3	2	0	0
angioedema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
alopecia areata
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
alopecia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	1 / 11 (9.09%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	1	1	0	0	0
dermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	1	0	0	0	0	0
dermatitis psoriasiform
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	2	0	0	0	0	0	0	0
dermatitis exfoliative generalised
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
dermatitis contact
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	0	2	0	0	1	0	0
dermatitis atopic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 30 (10.00%)	3 / 59 (5.08%)	3 / 59 (5.08%)	27 / 295 (9.15%)	0 / 5 (0.00%)	38 / 149 (25.50%)	0 / 11 (0.00%)	3 / 108 (2.78%)	6 / 125 (4.80%)	2 / 11 (18.18%)	0 / 9 (0.00%)
occurrences all number	3	3	3	31	0	41	0	3	8	2	0
diffuse alopecia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
drug eruption
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
dyshidrotic eczema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
eczema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	1	1	0	0
erythema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	0	0	0	1	0	0	0
hair disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
hyperhidrosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
intertrigo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
night sweats
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0
photosensitivity reaction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
pityriasis rosea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
purpura
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
psoriasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	2 / 108 (1.85%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0
pruritus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	5 / 295 (1.69%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	5	0	1	0	0	1	0	0
prurigo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
rash
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
rash erythematous
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0
rash papular
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
rosacea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0
seborrhoeic dermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
seborrhoea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
skin fissures
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	1 / 11 (9.09%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	1	0
skin disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
skin lesion inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
urticaria papular
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
urticaria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 295 (0.68%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	3	0	1	0	1	0	0	0
Renal and urinary disorders
acute kidney injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
bladder disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
bladder irritation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
chronic kidney disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
dysuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0	0
haematuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
hypertonic bladder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0
nephrolithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
pollakiuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0
renal colic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
renal disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
renal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Endocrine disorders
autoimmune thyroiditis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	3 / 295 (1.02%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	3 / 108 (2.78%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	1	3	0	1	0	3	0	0	2
arthritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
back pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	2 / 59 (3.39%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	2	0	0	0	0	1	3	0	0
bursitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	1 / 11 (9.09%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0
coccydynia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
costochondritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
flank pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
joint swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
muscle spasms
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
musculoskeletal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
myalgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	1 / 11 (9.09%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0
osteitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
pain in jaw
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
pain in extremity
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	1 / 5 (20.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	1	2	0	0	2	0	0
synovial cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
tenosynovitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
tendonitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Infections and infestations
appendicitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
asymptomatic bacteriuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
body tinea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	1 / 11 (9.09%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
bronchitis bacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
bronchitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0	0
covid-19
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	3 / 59 (5.08%)	1 / 59 (1.69%)	2 / 295 (0.68%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	6 / 108 (5.56%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	3	1	2	0	2	0	7	2	0	0
cellulitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
conjunctivitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 30 (6.67%)	5 / 59 (8.47%)	0 / 59 (0.00%)	21 / 295 (7.12%)	0 / 5 (0.00%)	3 / 149 (2.01%)	0 / 11 (0.00%)	5 / 108 (4.63%)	3 / 125 (2.40%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	3	6	0	22	0	3	0	5	3	0	0
conjunctivitis bacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 295 (1.02%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	3	0	0	0	1	1	0	0
demodicidosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0
cystitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	1 / 59 (1.69%)	2 / 295 (0.68%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	2	2	0	1	0	0	1	0	0
dermatophytosis of nail
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
dermatitis infected
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
eczema herpeticum
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
eczema impetiginous
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
eczema infected
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0
erysipelas
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
folliculitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	3 / 59 (5.08%)	3 / 59 (5.08%)	1 / 295 (0.34%)	0 / 5 (0.00%)	3 / 149 (2.01%)	1 / 11 (9.09%)	2 / 108 (1.85%)	3 / 125 (2.40%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	3	3	1	0	3	1	2	3	0	0
fungal skin infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
gastroenteritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	3 / 295 (1.02%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	4	0	1	0	1	1	0	0
genital herpes simplex
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
herpes zoster
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	1	0	0
herpes simplex
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	3	0	0	0	0	1	0	0
hordeolum
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	1	0	0	0
herpes dermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	2 / 59 (3.39%)	1 / 59 (1.69%)	1 / 295 (0.34%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	1 / 108 (0.93%)	2 / 125 (1.60%)	1 / 11 (9.09%)	0 / 9 (0.00%)
occurrences all number	0	2	1	1	0	2	0	1	3	1	0
impetigo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	3 / 149 (2.01%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	3	0	3	0	0	0
influenza
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	1	0	0
large intestine infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
localised infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
molluscum contagiosum
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
nasopharyngitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	3 / 59 (5.08%)	3 / 59 (5.08%)	15 / 295 (5.08%)	0 / 5 (0.00%)	3 / 149 (2.01%)	2 / 11 (18.18%)	6 / 108 (5.56%)	10 / 125 (8.00%)	1 / 11 (9.09%)	1 / 9 (11.11%)
occurrences all number	2	3	5	17	0	3	2	10	14	1	1
ophthalmic herpes zoster
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
oral herpes
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	2 / 59 (3.39%)	0 / 59 (0.00%)	4 / 295 (1.36%)	0 / 5 (0.00%)	3 / 149 (2.01%)	0 / 11 (0.00%)	4 / 108 (3.70%)	3 / 125 (2.40%)	1 / 11 (9.09%)	0 / 9 (0.00%)
occurrences all number	1	2	0	4	0	3	0	7	4	1	0
oral infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
otitis externa
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
paronychia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 295 (0.68%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	2	0	0	0	1	0	0	0
perineal abscess
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
pharyngitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	0
pneumonia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	2 / 59 (3.39%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0
pharyngitis streptococcal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
pharyngotonsillitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
post procedural infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
rhinitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0
skin infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 30 (3.33%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	2	0	1	0	0	0	0	0
superinfection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
subcutaneous abscess
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
superinfection bacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
tinea barbae
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
tinea capitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
tinea cruris
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
tinea infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
tinea pedis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	1	1	0	0	0	1	0	0	0
tinea versicolour
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
tonsillitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	2 / 108 (1.85%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0
tonsillitis bacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	1 / 125 (0.80%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
tooth abscess
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
tooth infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
upper respiratory tract infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	1 / 59 (1.69%)	1 / 59 (1.69%)	0 / 295 (0.00%)	0 / 5 (0.00%)	2 / 149 (1.34%)	0 / 11 (0.00%)	4 / 108 (3.70%)	2 / 125 (1.60%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	1	1	0	0	2	0	4	2	0	0
urinary tract infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	3 / 59 (5.08%)	3 / 59 (5.08%)	5 / 295 (1.69%)	1 / 5 (20.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	2 / 108 (1.85%)	3 / 125 (2.40%)	1 / 11 (9.09%)	0 / 9 (0.00%)
occurrences all number	0	4	5	5	1	1	0	5	3	1	0
viral infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
vulvovaginal candidiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[11]	0 / 15 (0.00%)	0 / 34 (0.00%)	0 / 33 (0.00%)	0 / 147 (0.00%)	0 / 3 (0.00%)	1 / 78 (1.28%)	0 / 6 (0.00%)	0 / 54 (0.00%)	0 / 55 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
glucose tolerance impaired
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
gout
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
hyperkalaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
hypercholesterolaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	2 / 11 (18.18%)	1 / 108 (0.93%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	2	1	0	0	0
hypoglycaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	1 / 149 (0.67%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
hypokalaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 295 (0.00%)	0 / 5 (0.00%)	0 / 149 (0.00%)	1 / 11 (9.09%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
obesity
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 295 (0.34%)	0 / 5 (0.00%)	0 / 149 (0.00%)	0 / 11 (0.00%)	0 / 108 (0.00%)	0 / 125 (0.00%)	0 / 11 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0

Notes
[2] - 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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[3] - 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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[5] - 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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[6] - 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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[7] - 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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[8] - 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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[9] - 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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[10] - 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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
[11] - 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: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

More information

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Were there any global substantial amendments to the protocol? Yes

20 May 2020

Revised to align with FDA and EU received recommendations and regulations, to add more clarifications and ensuring consistencies between different sections, and to be consistent across the Phase 3 studies of Lebrikizumab in atopic dermatitis.

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.

One investigational site with eighteen participants was excluded from analysis due to GCP issues.

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Clinical trials

Clinical Trial Results: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

Primary: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

Primary: Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

Primary: Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

Secondary: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 2

Secondary: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 2

Secondary: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 4

Secondary: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 4

Secondary: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16

Secondary: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16

Secondary: Percentage of participants achieving EASI-90 (≥90% reduction in EASI score) from Baseline to Week 16

Secondary: Percentage of participants achieving EASI-90 (≥90% reduction in EASI score) from Baseline to Week 16

Secondary: Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16

Secondary: Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16

Secondary: Percentage of participants with a Pruritus NRS score of ≥4-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16

Secondary: Percentage of participants with a Pruritus NRS score of ≥4-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16

Secondary: Percentage of participants with a Pruritus NRS score of ≥5-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16

Secondary: Percentage of participants with a Pruritus NRS score of ≥5-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16

Secondary: Percentage change in EASI score from Baseline to Week 16

Secondary: Percentage change in EASI score from Baseline to Week 16

Secondary: Change From Baseline in Percent Body Surface Area (BSA) at Week 16

Secondary: Change From Baseline in Percent Body Surface Area (BSA) at Week 16

Secondary: Percentage of participants achieving EASI-90 from Baseline to Week 4

Secondary: Percentage of participants achieving EASI-90 from Baseline to Week 4

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Percentage of participants achieving ≥4-point improvement in DLQI from Baseline to Week 16

Secondary: Percentage of participants achieving ≥4-point improvement in DLQI from Baseline to Week 16

Secondary: Percentage of participants with a DLQI total score of ≥4-point at baseline achieving ≥4-point improvement in DLQI from baseline to Week 16

Secondary: Percentage of participants with a DLQI total score of ≥4-point at baseline achieving ≥4-point improvement in DLQI from baseline to Week 16

Secondary: Percentage change in Sleep-loss score from Baseline to Week 16

Secondary: Percentage change in Sleep-loss score from Baseline to Week 16

Secondary: Change from Baseline in Sleep-loss score at Week 16

Secondary: Change from Baseline in Sleep-loss score at Week 16

Secondary: Percentage of participants with a Sleep-loss score ≥2 points at Baseline who achieve a ≥2 points reduction from Baseline to Week 16

Secondary: Percentage of participants with a Sleep-loss score ≥2 points at Baseline who achieve a ≥2 points reduction from Baseline to Week 16

Secondary: Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1

Secondary: Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1

Secondary: Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2

Secondary: Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2

Secondary: Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4

Secondary: Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4

Secondary: Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1

Secondary: Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1

Secondary: Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2

Secondary: Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2

Secondary: Percentage Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16

Secondary: Percentage Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16

Secondary: Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)

Secondary: Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)

Secondary: Percentage of participants from those re-randomized having achieved EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-75 calculated relative to baseline EASI score)

Secondary: Percentage of participants from those re-randomized having achieved EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-75 calculated relative to baseline EASI score)

Secondary: Percentage of participants from those re-randomized having achieved IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 16 who continue to exhibit an IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 52

Secondary: Percentage of participants from those re-randomized having achieved IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 16 who continue to exhibit an IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 52

Secondary: Percentage of participants from those with a Pruritus NRS of ≥4-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52

Secondary: Percentage of participants from those with a Pruritus NRS of ≥4-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52

Secondary: Percentage of participants from those with a Pruritus NRS of ≥5-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52

Secondary: Percentage of participants from those with a Pruritus NRS of ≥5-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52

Secondary: Percentage change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) from baseline at Week 52

Secondary: Percentage change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) from baseline at Week 52

Secondary: Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

Secondary: Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

Secondary: Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

Secondary: Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

Secondary: Change from Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

Secondary: Change from Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

Secondary: Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents

Secondary: Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents

Secondary: Change From Baseline in PROMIS Anxiety at Week 16 - Adults

Secondary: Change From Baseline in PROMIS Anxiety at Week 16 - Adults

Clinical Trial Results:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS