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Clinical Trial Results:
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants with Systemic Lupus Erythematosus (SLE) (Illuminate-X)

Summary
EudraCT number	2010-022101-18
Trial protocol	AT HU ES LV BG IT GB DE HR
Global end of trial date	20 Oct 2015

Results information
Results version number	v1(current)
This version publication date	11 Apr 2018
First version publication date	11 Apr 2018
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

H9B-MC-BCDX

ISRCTN number

-

US NCT number

NCT01488708

WHO universal trial number (UTN)

-

Other trial identifiers

Trial Number : 13811

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)

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

06 Jan 2012

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

20 Oct 2015

Was the trial ended prematurely?

Yes

Main objective of the trial

The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438). The trial was terminated early due to lack of efficacy.

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

06 Jan 2012

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 532

Country: Number of subjects enrolled

Puerto Rico: 15

Country: Number of subjects enrolled

Canada: 6

Country: Number of subjects enrolled

Peru: 69

Country: Number of subjects enrolled

Brazil: 54

Country: Number of subjects enrolled

Mexico: 51

Country: Number of subjects enrolled

Ecuador: 41

Country: Number of subjects enrolled

Argentina: 39

Country: Number of subjects enrolled

Colombia: 30

Country: Number of subjects enrolled

Guatemala: 30

Country: Number of subjects enrolled

Chile: 10

Country: Number of subjects enrolled

Philippines: 59

Country: Number of subjects enrolled

Taiwan: 42

Country: Number of subjects enrolled

Japan: 36

Country: Number of subjects enrolled

Korea, Republic of: 29

Country: Number of subjects enrolled

Thailand: 24

Country: Number of subjects enrolled

Australia: 9

Country: Number of subjects enrolled

New Zealand: 5

Country: Number of subjects enrolled

Malaysia: 2

Country: Number of subjects enrolled

Singapore: 1

Country: Number of subjects enrolled

Serbia: 63

Country: Number of subjects enrolled

Hungary: 44

Country: Number of subjects enrolled

Poland: 41

Country: Number of subjects enrolled

Russian Federation: 38

Country: Number of subjects enrolled

Ukraine: 31

Country: Number of subjects enrolled

Romania: 23

Country: Number of subjects enrolled

Spain: 22

Country: Number of subjects enrolled

Germany: 15

Country: Number of subjects enrolled

Belarus: 11

Country: Number of subjects enrolled

Bulgaria: 11

Country: Number of subjects enrolled

Latvia: 9

Country: Number of subjects enrolled

Macedonia, the former Yugoslav Republic of: 8

Country: Number of subjects enrolled

Austria: 4

Country: Number of subjects enrolled

Italy: 3

Country: Number of subjects enrolled

Croatia: 2

Country: Number of subjects enrolled

France: 2

Country: Number of subjects enrolled

Tunisia: 40

Country: Number of subjects enrolled

South Africa: 31

Country: Number of subjects enrolled

Israel: 22

Country: Number of subjects enrolled

Egypt: 9

Country: Number of subjects enrolled

United Kingdom: 5

Worldwide total number of subjects

1518

EEA total number of subjects

181

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

1474

From 65 to 84 years

43

85 years and over

1

Subject disposition

Top of page

Recruitment details

-

Screening details

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

LY 2127399 Q2W

Arm description

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Arm type

Experimental

Investigational medicinal product name

LY2127399 every 2 weeks

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.

LY2127399 Q4W

Arm description

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Arm type

Experimental

Investigational medicinal product name

LY2127399 every 4 weeks

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.

Number of subjects in period 1	LY 2127399 Q2W	LY2127399 Q4W
Started	940	578
Received at least 1 Dose of Study Drug	937	578
Participated in Follow Up	810	526
Completed	0	0
Not completed	940	578
Study Termination	940	578

Baseline characteristics

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Reporting group title

LY 2127399 Q2W

Reporting group description

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Reporting group title

LY2127399 Q4W

Reporting group description

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Reporting group values	LY 2127399 Q2W	LY2127399 Q4W	Total
Number of subjects	940	578	1518
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn - gestational age < 37 0 wk	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	910	564	1474
From 65 to 84 years	29	14	43
85 years and over	1	0	1
Gender, Male/Female
Units:
Male	60	51	111
Female	880	527	1407
Race Stratification
Units: Subjects
Black or African American	138	45	183
Non-black or Non-African American	802	533	1335
Race
Units: Subjects
American Indian or Alaska Native	104	94	198
Asian	113	96	209
Black or African American	130	33	163
Native Hawaiian or Other Pacific Islander	0	1	1
White	579	337	916
Multiple	14	17	31
Ethnicity
Units: Subjects
Hispanic or Latino	265	189	454
Not Hispanic or Latino	612	314	926
Not Applicable	63	75	138
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score [1] Mean (Stand
Units: units on a scale
arithmetic mean (standard deviation)	5.4 ± 3.81	4.9 ± 3.74	-

End points

Top of page

Reporting group title

LY 2127399 Q2W

Reporting group description

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Reporting group title

LY2127399 Q4W

Reporting group description

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Primary: Number of Adverse Events (AEs)

Top of page

End point title

Number of Adverse Events (AEs) ^[1]

End point description

A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

End point type

Primary

End point timeframe

Baseline through 4 years

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed as per protocol. It was a number value of Adverse Events (AEs).

End point values	LY 2127399 Q2W	LY2127399 Q4W
Number of subjects analysed	937 ^[2]	578 ^[3]
Units: participants
number (not applicable)	73.3	65.6

Notes
[2] - All participants who received at least 1 dose of study drug.
[3] - All participants who received at least 1 dose of study drug.

No statistical analyses for this end point

Secondary: Proportion of participants with a systemic lupus erythematosus (SLE) responder index (SRI) response

Top of page

End point title

Proportion of participants with a systemic lupus erythematosus (SLE) responder index (SRI) response

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	LY 2127399 Q2W	LY2127399 Q4W
Number of subjects analysed	0 ^[4]	0 ^[5]
Units: participants
number (not applicable)

Notes
[4] - Zero participants were analyzed due to early termination of the study.
[5] - Zero participants were analyzed due to early termination of the study.

No statistical analyses for this end point

Secondary: Proportion of participants with a reduction in steroid dose

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End point title

Proportion of participants with a reduction in steroid dose

End point description

End point type

Secondary

End point timeframe

Baseline through 4 years

End point values	LY 2127399 Q2W	LY2127399 Q4W
Number of subjects analysed	0 ^[6]	0 ^[7]
Units: participants
number (not applicable)

Notes
[6] - Zero participants were analyzed due to early termination of the study.
[7] - Zero participants were analyzed due to early termination of the study.

No statistical analyses for this end point

Secondary: Change in SLE Disease Activity Index

Top of page

End point title

Change in SLE Disease Activity Index

End point description

End point type

Secondary

End point timeframe

Baseline, 4 years

End point values	LY 2127399 Q2W	LY2127399 Q4W
Number of subjects analysed	0 ^[8]	0 ^[9]
Units: percent
number (not applicable)

Notes
[8] - Zero participants were analyzed due to early termination of the study.
[9] - Zero participants were analyzed due to early termination of the study.

No statistical analyses for this end point

Secondary: Occurrence of new severe SLE flares

Top of page

End point title

Occurrence of new severe SLE flares

End point description

End point type

Secondary

End point timeframe

Baseline through 4 years

End point values	LY 2127399 Q2W	LY2127399 Q4W
Number of subjects analysed	0 ^[10]	0 ^[11]
Units: count
number (not applicable)

Notes
[10] - Zero participants were analyzed due to early termination of the study.
[11] - Zero participants were analyzed due to early termination of the study.

No statistical analyses for this end point

Secondary: Proportion of participants with improvement in Lupus Quality of Life

Top of page

End point title

Proportion of participants with improvement in Lupus Quality of Life

End point description

End point type

Secondary

End point timeframe

4 years

End point values	LY 2127399 Q2W	LY2127399 Q4W
Number of subjects analysed	0 ^[12]	0 ^[13]
Units: percent
number (not applicable)

Notes
[12] - Zero participants were analyzed due to early termination of the study.
[13] - Zero participants were analyzed due to early termination of the study.

No statistical analyses for this end point

Secondary: Change in anti-double-stranded deoxyribonucleic acid level

Top of page

End point title

Change in anti-double-stranded deoxyribonucleic acid level

End point description

End point type

Secondary

End point timeframe

Baseline, 4 years

End point values	LY 2127399 Q2W	LY2127399 Q4W
Number of subjects analysed	0 ^[14]	0 ^[15]
Units: percent
number (not applicable)

Notes
[14] - Zero participants were analyzed due to early termination of the study.
[15] - Zero participants were analyzed due to early termination of the study.

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Entire Study

Adverse event reporting additional description

H9B-MC-BCDX

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

LY 2127399 Q2W Treatment

Reporting group description

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Reporting group title

LY2127399 Q4W Treatment Period

Reporting group description

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Reporting group title

LY 2127399 Q2W Follow Up

Reporting group description

If participant received LY2127399 in core study, 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo during core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. Follow up.n

Reporting group title

LY2127399 Q4W Follow Up

Reporting group description

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. Follow up.

Serious adverse events	LY 2127399 Q2W Treatment	LY2127399 Q4W Treatment Period	LY 2127399 Q2W Follow Up	LY2127399 Q4W Follow Up
Total subjects affected by serious adverse events
subjects affected / exposed	129 / 937 (13.77%)	64 / 578 (11.07%)	41 / 810 (5.06%)	38 / 526 (7.22%)
number of deaths (all causes)	5	2	2	2
number of deaths resulting from adverse events	1	0	1	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
benign breast neoplasm
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
benign vaginal neoplasm
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[1]	1 / 877 (0.11%)	0 / 527 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
breast cancer
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
brenner tumour
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[2]	1 / 877 (0.11%)	0 / 527 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
haemangioma
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
neuroendocrine tumour
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
prostate cancer
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[3]	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 50 (0.00%)	1 / 44 (2.27%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
squamous cell carcinoma of skin
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
squamous cell carcinoma of the cervix
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[4]	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 760 (0.00%)	1 / 482 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
uterine cancer
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[5]	1 / 877 (0.11%)	0 / 527 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
uterine leiomyoma
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[6]	1 / 877 (0.11%)	0 / 527 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
deep vein thrombosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
extremity necrosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypertension
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	4 / 937 (0.43%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypotension
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	1 / 578 (0.17%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
infarction
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
orthostatic hypotension
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
peripheral arterial occlusive disease
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
poor venous access
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
shock haemorrhagic
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
thrombophlebitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vasculitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
venous occlusion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
venous thrombosis limb
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
abortion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[7]	1 / 877 (0.11%)	0 / 527 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
abortion spontaneous
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[8]	1 / 877 (0.11%)	1 / 527 (0.19%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
blighted ovum
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[9]	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 760 (0.00%)	1 / 482 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ectopic pregnancy
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[10]	1 / 877 (0.11%)	0 / 527 (0.00%)	1 / 760 (0.13%)	0 / 482 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
death
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
device dislocation
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
implant site erosion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
medical device complication
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
non-cardiac chest pain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	1 / 578 (0.17%)	3 / 810 (0.37%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pelvic mass
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pyrexia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	2 / 810 (0.25%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
drug hypersensitivity
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
benign prostatic hyperplasia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[11]	0 / 60 (0.00%)	1 / 51 (1.96%)	0 / 50 (0.00%)	1 / 44 (2.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dysmenorrhoea
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[12]	0 / 877 (0.00%)	1 / 527 (0.19%)	0 / 760 (0.00%)	1 / 482 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
metrorrhagia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[13]	1 / 877 (0.11%)	0 / 527 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ovarian cyst
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[14]	0 / 877 (0.00%)	1 / 527 (0.19%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
acute respiratory failure
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
asthma
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
atelectasis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
chronic obstructive pulmonary disease
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	4 / 937 (0.43%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dyspnoea
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
haemoptysis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypoxia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
interstitial lung disease
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pleural effusion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	2 / 578 (0.35%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pleural fibrosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary congestion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary embolism
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	2 / 810 (0.25%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary haemorrhage
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
pulmonary hypertension
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary oedema
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
upper airway obstruction
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
conversion disorder
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
delirium tremens
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
depression
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
generalised anxiety disorder
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
mental status changes
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
suicide attempt
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
electrocardiogram qrs complex shortened
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
lipase increased
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
ankle fracture
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bone fissure
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bronchial injury
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
concussion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
contusion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
fall
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
femoral neck fracture
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
femur fracture
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
fibula fracture
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gun shot wound
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
head injury
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
joint injury
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ligament rupture
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ligament sprain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
muscle strain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
overdose
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
procedural intestinal perforation
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
respiratory fume inhalation disorder
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
road traffic accident
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
spinal compression fracture
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 937 (0.32%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
subdural haematoma
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vascular pseudoaneurysm
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
acute myocardial infarction
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 937 (0.32%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
angina pectoris
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
atrioventricular block
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
atrioventricular block complete
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
atrioventricular block second degree
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bundle branch block bilateral
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cardiac arrest
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
cardiac failure congestive
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cardio-respiratory arrest
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
coronary artery disease
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
myocardial fibrosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
myocardial infarction
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pericardial effusion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pericarditis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
right ventricular failure
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tachycardia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	2 / 578 (0.35%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tricuspid valve disease
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
autonomic nervous system imbalance
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
carotid artery dissection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cerebrovascular disorder
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
epilepsy
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
headache
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hemiparesis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
iiird nerve disorder
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
migraine
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
neuropathy peripheral
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
neuropsychiatric lupus
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
optic neuritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
subarachnoid haemorrhage
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
syncope
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	2 / 578 (0.35%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tension headache
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
transient ischaemic attack
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
viith nerve paralysis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vith nerve disorder
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
anaemia macrocytic
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
autoimmune haemolytic anaemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
febrile neutropenia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
haemolytic anaemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
haemolytic uraemic syndrome
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
haemorrhagic anaemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
histiocytosis haematophagic
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
iron deficiency anaemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 937 (0.32%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
leukopenia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
lymphopenia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
microcytic anaemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
neutropenia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	2 / 578 (0.35%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
thrombocytopenia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
thrombotic thrombocytopenic purpura
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
vertigo
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
amaurosis fugax
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cataract
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diplopia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
eyelid ptosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	4 / 937 (0.43%)	2 / 578 (0.35%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 4	1 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
colitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
colitis ulcerative
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	1 / 578 (0.17%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
constipation
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastric ulcer perforation
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 937 (0.32%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastritis erosive
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastrointestinal haemorrhage
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
haemorrhoidal haemorrhage
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hiatus hernia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
intestinal ischaemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
intestinal perforation
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
large intestine polyp
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
oesophagitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pancreatitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pancreatitis acute
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
rectal haemorrhage
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
retroperitoneal haemorrhage
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
small intestinal obstruction
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
cholecystitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 937 (0.32%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cholecystitis acute
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cholecystitis chronic
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cholelithiasis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	1 / 578 (0.17%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
drug-induced liver injury
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hepatic function abnormal
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
liver disorder
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
nodular regenerative hyperplasia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
angioedema
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dry gangrene
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
mucocutaneous ulceration
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
precancerous skin lesion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
psoriasis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
skin ulcer
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
bladder prolapse
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
calculus ureteric
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
glomerulonephritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hydronephrosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
lupus nephritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	2 / 810 (0.25%)	3 / 526 (0.57%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
nephrolithiasis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
renal failure acute
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	2 / 578 (0.35%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
urinary retention
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
adrenal insufficiency
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
adrenocortical insufficiency acute
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
mineralocorticoid deficiency
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
arthritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
back pain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bursitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
chondrocalcinosis pyrophosphate
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
costochondritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
intervertebral disc protrusion
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
lumbar spinal stenosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
muscle haemorrhage
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
muscular weakness
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
musculoskeletal chest pain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
musculoskeletal pain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
osteoarthritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	1 / 578 (0.17%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
osteonecrosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	8 / 937 (0.85%)	2 / 578 (0.35%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 9	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pain in extremity
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sle arthritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
spinal osteoarthritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
systemic lupus erythematosus
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	4 / 937 (0.43%)	3 / 578 (0.52%)	1 / 810 (0.12%)	4 / 526 (0.76%)
occurrences causally related to treatment / all	0 / 4	1 / 4	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tendon disorder
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
abdominal abscess
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
abscess
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
amoebiasis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
appendicitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	2 / 578 (0.35%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
arthritis bacterial
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bacteraemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
blastocystis infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
brain abscess
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bronchitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bronchitis bacterial
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cellulitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 937 (0.32%)	1 / 578 (0.17%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 3	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cervicitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[15]	0 / 877 (0.00%)	1 / 527 (0.19%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cytomegalovirus infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diverticulitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
enterocolitis bacterial
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
escherichia urinary tract infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastroenteritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	2 / 937 (0.21%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
groin abscess
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
herpes zoster
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	1 / 578 (0.17%)	0 / 810 (0.00%)	2 / 526 (0.38%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
herpes zoster disseminated
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
infectious colitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
influenza
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
kidney infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
lobar pneumonia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	1 / 810 (0.12%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
localised infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
meningitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
meningitis cryptococcal
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
meningitis viral
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
oesophageal candidiasis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ophthalmic herpes zoster
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
oral fungal infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
peritonitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
peritonsillar abscess
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pharyngotonsillitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumococcal sepsis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	11 / 937 (1.17%)	1 / 578 (0.17%)	1 / 810 (0.12%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	8 / 12	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
pneumonia bacterial
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
post procedural infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary tuberculosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
pyelonephritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pyonephrosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
respiratory tract infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sepsis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 937 (0.32%)	1 / 578 (0.17%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 3	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
sepsis syndrome
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
septic shock
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sinusitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
staphylococcal sepsis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
staphylococcal skin infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
subcutaneous abscess
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tooth abscess
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
upper respiratory tract infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 937 (0.32%)	1 / 578 (0.17%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	2 / 3	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
urinary tract infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 937 (0.32%)	3 / 578 (0.52%)	2 / 810 (0.25%)	3 / 526 (0.57%)
occurrences causally related to treatment / all	2 / 3	2 / 3	2 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
varicella
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	1 / 578 (0.17%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
viral infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vulval cellulitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed ^[16]	1 / 877 (0.11%)	0 / 527 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
cholesterosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dehydration
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diabetes mellitus
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diabetes mellitus inadequate control
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hyperglycaemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypoglycaemia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	2 / 578 (0.35%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ketosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 937 (0.11%)	0 / 578 (0.00%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
metabolic acidosis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 937 (0.00%)	0 / 578 (0.00%)	1 / 810 (0.12%)	0 / 526 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	LY 2127399 Q2W Treatment	LY2127399 Q4W Treatment Period	LY 2127399 Q2W Follow Up	LY2127399 Q4W Follow Up
Total subjects affected by non serious adverse events
subjects affected / exposed	464 / 937 (49.52%)	232 / 578 (40.14%)	110 / 810 (13.58%)	75 / 526 (14.26%)
Vascular disorders
hypertension
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	27 / 937 (2.88%)	8 / 578 (1.38%)	3 / 810 (0.37%)	1 / 526 (0.19%)
occurrences all number	27	10	3	1
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	18 / 937 (1.92%)	12 / 578 (2.08%)	2 / 810 (0.25%)	2 / 526 (0.38%)
occurrences all number	19	13	2	2
headache
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	53 / 937 (5.66%)	28 / 578 (4.84%)	13 / 810 (1.60%)	6 / 526 (1.14%)
occurrences all number	67	34	13	6
General disorders and administration site conditions
fatigue
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	19 / 937 (2.03%)	7 / 578 (1.21%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences all number	20	7	0	1
pyrexia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	20 / 937 (2.13%)	4 / 578 (0.69%)	3 / 810 (0.37%)	1 / 526 (0.19%)
occurrences all number	25	4	4	1
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	21 / 937 (2.24%)	3 / 578 (0.52%)	2 / 810 (0.25%)	1 / 526 (0.19%)
occurrences all number	21	3	2	1
abdominal pain upper
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	9 / 937 (0.96%)	12 / 578 (2.08%)	5 / 810 (0.62%)	1 / 526 (0.19%)
occurrences all number	9	12	5	1
diarrhoea
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	59 / 937 (6.30%)	18 / 578 (3.11%)	7 / 810 (0.86%)	2 / 526 (0.38%)
occurrences all number	70	21	7	2
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	23 / 937 (2.45%)	7 / 578 (1.21%)	0 / 810 (0.00%)	0 / 526 (0.00%)
occurrences all number	24	7	0	0
nausea
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	34 / 937 (3.63%)	12 / 578 (2.08%)	6 / 810 (0.74%)	1 / 526 (0.19%)
occurrences all number	36	14	6	1
vomiting
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	21 / 937 (2.24%)	10 / 578 (1.73%)	3 / 810 (0.37%)	1 / 526 (0.19%)
occurrences all number	23	10	4	1
Respiratory, thoracic and mediastinal disorders
cough
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	28 / 937 (2.99%)	10 / 578 (1.73%)	9 / 810 (1.11%)	0 / 526 (0.00%)
occurrences all number	29	13	9	0
Skin and subcutaneous tissue disorders
rash
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	23 / 937 (2.45%)	6 / 578 (1.04%)	0 / 810 (0.00%)	1 / 526 (0.19%)
occurrences all number	28	8	0	1
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	21 / 937 (2.24%)	10 / 578 (1.73%)	3 / 810 (0.37%)	1 / 526 (0.19%)
occurrences all number	21	11	3	1
insomnia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	18 / 937 (1.92%)	12 / 578 (2.08%)	4 / 810 (0.49%)	3 / 526 (0.57%)
occurrences all number	18	12	4	3
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	33 / 937 (3.52%)	12 / 578 (2.08%)	10 / 810 (1.23%)	3 / 526 (0.57%)
occurrences all number	39	16	11	3
back pain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	36 / 937 (3.84%)	17 / 578 (2.94%)	6 / 810 (0.74%)	4 / 526 (0.76%)
occurrences all number	39	17	6	4
pain in extremity
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	27 / 937 (2.88%)	6 / 578 (1.04%)	5 / 810 (0.62%)	3 / 526 (0.57%)
occurrences all number	29	8	5	3
Infections and infestations
bronchitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	57 / 937 (6.08%)	26 / 578 (4.50%)	10 / 810 (1.23%)	8 / 526 (1.52%)
occurrences all number	74	32	10	9
gastroenteritis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	14 / 937 (1.49%)	16 / 578 (2.77%)	4 / 810 (0.49%)	6 / 526 (1.14%)
occurrences all number	18	16	4	6
nasopharyngitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	63 / 937 (6.72%)	40 / 578 (6.92%)	12 / 810 (1.48%)	8 / 526 (1.52%)
occurrences all number	83	46	12	8
pharyngitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	27 / 937 (2.88%)	15 / 578 (2.60%)	1 / 810 (0.12%)	2 / 526 (0.38%)
occurrences all number	33	16	1	2
sinusitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	56 / 937 (5.98%)	17 / 578 (2.94%)	9 / 810 (1.11%)	3 / 526 (0.57%)
occurrences all number	64	28	9	3
upper respiratory tract infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	104 / 937 (11.10%)	51 / 578 (8.82%)	18 / 810 (2.22%)	11 / 526 (2.09%)
occurrences all number	142	68	18	12
urinary tract infection
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	106 / 937 (11.31%)	52 / 578 (9.00%)	20 / 810 (2.47%)	16 / 526 (3.04%)
occurrences all number	158	78	21	18

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

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

Insufficient data available for analysis since study terminated early due to lack of efficacy in parent studies.

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