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Clinical Trial Results:
The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study

Summary
EudraCT number	2011-001253-82
Trial protocol	SE GB LT BE ES IE DK GR NL SI
Global end of trial date	03 Feb 2014

Results information
Results version number	v1(current)
This version publication date	02 Apr 2018
First version publication date	02 Apr 2018
Other versions

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

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Trial information

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Sponsor protocol code

I2R-MC-BIAO

ISRCTN number

US NCT number

NCT01454284

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 12147

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)

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

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

Analysis stage

Final

Date of interim/final analysis

03 Feb 2014

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

03 Feb 2014

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is: • To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. • To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. • To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment. • To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment

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

11 Jan 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 572

Country: Number of subjects enrolled

Slovakia: 10

Country: Number of subjects enrolled

Greece: 23

Country: Number of subjects enrolled

Spain: 74

Country: Number of subjects enrolled

Ireland: 5

Country: Number of subjects enrolled

Lithuania: 7

Country: Number of subjects enrolled

Israel: 22

Country: Number of subjects enrolled

United Kingdom: 63

Country: Number of subjects enrolled

France: 19

Country: Number of subjects enrolled

Canada: 52

Country: Number of subjects enrolled

Belgium: 36

Country: Number of subjects enrolled

Brazil: 30

Country: Number of subjects enrolled

Poland: 84

Country: Number of subjects enrolled

Croatia: 10

Country: Number of subjects enrolled

Denmark: 1

Country: Number of subjects enrolled

Australia: 39

Country: Number of subjects enrolled

South Africa: 24

Country: Number of subjects enrolled

Netherlands: 3

Country: Number of subjects enrolled

New Zealand: 14

Country: Number of subjects enrolled

Sweden: 26

Worldwide total number of subjects

1114

EEA total number of subjects

361

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

1055

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

No text entered

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

LY2605541 + Insulin Lispro

Arm description

Includes participants randomized to receive LY2605541 plus Insulin Lispro. Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 52 weeks. Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks.

Arm type

Experimental

Investigational medicinal product name

LY2605541

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily for 52 weeks.

Investigational medicinal product name

INSULIN LISPRO

Investigational medicinal product code

Other name

Humalog

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participant-specific dose of Insulin Lispro was administered through Subcutaneous route for 52 weeks.

Insulin Glargine + Insulin Lispro

Arm description

Includes participants randomized to receive Insulin Glargine plus Insulin Lispro. Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks. Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks.

Arm type

Active comparator

Investigational medicinal product name

Insulin Glargine

Investigational medicinal product code

Other name

Lantus

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participant-specific dose of Insulin Glargine was administered Subcutaneously for 52 weeks.

Investigational medicinal product name

Insulin Lispro

Investigational medicinal product code

Other name

Humalog

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participant-specific dose of Insulin Lispro was administered through Subcutaneous route for 52 weeks.

Number of subjects in period 1	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Started	664	450
Received at Least 1 Dose of Study Drug	663	449
Completed	548	377
Not completed	116	73
Adverse event, serious fatal	-	3
Consent withdrawn by subject	58	36
Physician decision	16	11
Adverse event, non-fatal	20	7
Sponsor Decision	-	2
Lost to follow-up	13	8
Protocol deviation	9	6

Baseline characteristics

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Reporting group title

LY2605541 + Insulin Lispro

Reporting group description

Reporting group title

Insulin Glargine + Insulin Lispro

Reporting group description

Reporting group values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro	Total
Number of subjects	664	450	1114
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	41.58 ± 13.5	42.28 ± 13.16	-
Gender, Male/Female
Units:
Female	267	169	436
Male	397	281	678
Region of Enrollment
Units: Subjects
United States	343	229	572
Slovakia	5	5	10
Greece	15	8	23
Spain	44	30	74
Ireland	2	3	5
Lithuania	2	5	7
Israel	13	9	22
United Kingdom	38	25	63
France	12	7	19
Canada	33	19	52
Belgium	20	16	36
Brazil	19	11	30
Poland	51	33	84
Croatia	5	5	10
Denmark	0	1	1
Australia	22	17	39
South Africa	16	8	24
Netherlands	2	1	3
New Zealand	9	5	14
Sweden	13	13	26
Race
Units: Subjects
American Indian or Alaska Native	2	2	4
Asian	6	2	8
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	15	14	29
White	625	426	1051
More than one race	15	6	21
Ethnicity
Units: Subjects
Hispanic or Latino	23	18	41
Not Hispanic or Latino	477	315	792
Unknown or Not Reported	164	117	281

End points

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Reporting group title

LY2605541 + Insulin Lispro

Reporting group description

Reporting group title

Insulin Glargine + Insulin Lispro

Reporting group description

Primary: Hemoglobin A1c (HbA1c)

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End point title

Hemoglobin A1c (HbA1c)

End point description

HbA1c is a test that measures a participant’s average blood glucose level over a 2 to 3 month timeframe. Least squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, stratification factors (country, baseline low density lipoprotein cholesterol [LDL-C] [<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter [mmol/L]) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.

End point type

Primary

End point timeframe

52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	648	444
Units: percentage of HbA1c
least squares mean (standard error)	7.38 ± 0.03	7.61 ± 0.04

Statistical Analysis 1

Comparison groups

LY2605541 + Insulin Lispro v Insulin Glargine + Insulin Lispro

Number of subjects included in analysis

1092

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Confidence interval

Secondary: Hemoglobin A1c (HbA1c)

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End point title

Hemoglobin A1c (HbA1c)

End point description

HbA1c is a test that measures a participant’s average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

26 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	648	444
Units: percentage of HbA1c
least squares mean (standard error)	7.09 ± 0.03	7.42 ± 0.03

No statistical analyses for this end point

Secondary: Total hypoglycemia events

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End point title

Total hypoglycemia events

End point description

Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

Baseline through 26 weeks, Baseline through 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	662	449
Units: episodes/participant/30 days
arithmetic mean (standard error)
Weeks 0-26	16.83 ± 0.36	14.66 ± 0.36
Weeks 0-52	15.34 ± 0.32	13.88 ± 0.35

No statistical analyses for this end point

Secondary: Change from baseline to 52 weeks in HbA1c

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End point title

Change from baseline to 52 weeks in HbA1c

End point description

HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

Baseline, 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	648	444
Units: percentage of HbA1c
least squares mean (standard error)	-0.46 ± 0.03	-0.24 ± 0.04

No statistical analyses for this end point

Secondary: Percentage of participants with HbA1c equal to or less than 6.5% and less than 7.0%

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End point title

Percentage of participants with HbA1c equal to or less than 6.5% and less than 7.0%

End point description

The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.

End point type

Secondary

End point timeframe

up to 26 weeks, up to 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	648	444
Units: percentage of participants
number (not applicable)
HbA1c ≤6.5%, Week 26	29.6	17.8
HbA1c ≤6.5%, Week 52	20.8	15.1
HbA1c <7.0%, Week 26	45.1	34.5
HbA1c <7.0%, Week 52	35.3	26.1

No statistical analyses for this end point

Secondary: Percentage of participants with total hypoglycemic events

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End point title

Percentage of participants with total hypoglycemic events

End point description

Hypoglycemic episodes are defined as events that are associated with the reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

Baseline through 26 weeks, Baseline through 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	662	449
Units: percentage of participants
number (not applicable)
Weeks 0-26	99.1	99.3
Weeks 0-52	99.2	99.3

No statistical analyses for this end point

Secondary: Change in body weight

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End point title

Change in body weight

End point description

LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline body weight as fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

Baseline, 26 weeks, 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	648	439
Units: kilograms (kg)
least squares mean (standard error)
Week 26	-0.55 ± 0.14	0.78 ± 0.16
Week 52	-0.61 ± 0.17	1.21 ± 0.2

No statistical analyses for this end point

Secondary: Percentage of participants with nocturnal hypoglycemic events

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End point title

Percentage of participants with nocturnal hypoglycemic events

End point description

Hypoglycemic episodes are defined as events associated with the reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

Baseline through 26 weeks, Baseline through 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	662	449
Units: percentage of participants
number (not applicable)
Weeks 0-26	81.7	94.7
Weeks 0-52	87.5	96.2

No statistical analyses for this end point

Secondary: Nocturnal Hypoglycemia Rates

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End point title

Nocturnal Hypoglycemia Rates

End point description

Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

Baseline through 26 weeks, Baseline through 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	662	449
Units: events/participant/30 days
arithmetic mean (standard error)
Weeks 0-26	1.37 ± 0.07	2.7 ± 0.12
Weeks 0-52	1.31 ± 0.06	2.46 ± 0.1

No statistical analyses for this end point

Secondary: Percentage of participants with HbA1c less than 7.0% and without nocturnal hypoglycemia

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End point title

Percentage of participants with HbA1c less than 7.0% and without nocturnal hypoglycemia

End point description

Hypoglycemic episodes are defined as events associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.

End point type

Secondary

End point timeframe

up to 26 weeks, up to 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	648	444
Units: percentage of participants
number (not applicable)
Week 26	7.1	1.8
Week 52	4.3	1.1

No statistical analyses for this end point

Secondary: Fasting serum glucose (by laboratory measurement)

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End point title

Fasting serum glucose (by laboratory measurement)

End point description

Fasting serum glucose (FSG) is measured in blood before the morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

26 weeks and 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	646	443
Units: mg/dL
least squares mean (standard error)
Week 26	139.76 ± 2.75	155.23 ± 3.25
Week 52	142.02 ± 2.95	171.67 ± 3.48

No statistical analyses for this end point

Secondary: 9 point self-monitored blood glucose (SMBG)

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End point title

9 point self-monitored blood glucose (SMBG)

End point description

9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, and 52. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline BG values as the fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

26 weeks and 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	615	416
Units: mg/dL
least squares mean (standard error)
Pre-morning meal, Week 26 (n=615, 416)	153.85 ± 2.67	148.91 ± 3.17
Pre-morning meal, Week 52 (n=615, 416)	156.18 ± 2.75	155.25 ± 3.3
2 hour post-morning meal, Week 26 (n=572, 380)	164.59 ± 3.44	178.47 ± 4.07
2 hour post-morning meal, Week 52 (n=572, 380)	171.94 ± 3.43	183.35 ± 4.1
Pre-midday meal, Week 26 (n=611, 403)	136.7 ± 2.7	152.87 ± 3.22
Pre-midday meal, Week 52 (n=611, 403)	145.22 ± 2.87	158.5 ± 3.42
2 hour post-midday meal, Week 26 (n=579, 379)	150.66 ± 3.32	164.47 ± 3.94
2 hour post-midday meal, Week 52 (n=579, 379)	156.92 ± 3.73	172.61 ± 4.42
Pre-evening meal, Week 26 (n=603, 407)	155.38 ± 3.13	176.5 ± 3.73
Pre-evening meal, Week 52 (n=603, 407)	153.3 ± 3.21	170.83 ± 3.79
2 hour post-evening meal, Week 26 (n=559, 373)	160.5 ± 3.85	181.18 ± 4.54
2 hour post-evening meal, Week 52 (n=559, 373)	169.61 ± 4.19	184.19 ± 4.99
Bedtime, Week 26 (n=578, 382)	163.9 ± 3.24	180.97 ± 3.84
Bedtime, Week 52 (n=578, 382)	168.04 ± 3.58	187.09 ± 4.3
0300 Hours, Week 26 (n=529, 347)	169.64 ± 3.69	163.09 ± 4.39
0300 Hours, Week 52 (n=529, 347)	168.72 ± 3.94	174.11 ± 4.72
Pre-morning meal next day, Week 26 (n=583, 403)	150.04 ± 2.76	145.77 ± 3.23
Pre-morning meal next day, Week 52 (n=583, 403)	151.22 ± 2.7	149.56 ± 3.2

No statistical analyses for this end point

Secondary: 0300 hours blood glucose (BG) to fasting BG excursion

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End point title

0300 hours blood glucose (BG) to fasting BG excursion

End point description

Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only excursions within a single SMBG profile are included). LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline excursion as the fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.

End point type

Secondary

End point timeframe

26 weeks and 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	498	332
Units: mg/dL
least squares mean (standard error)
Week 26	-25.49 ± 3.96	-16.44 ± 4.72
Week 52	-23.36 ± 4.1	-29.01 ± 4.87

No statistical analyses for this end point

Secondary: Intra-participant variability of fasting blood glucose (FBG)

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End point title

Intra-participant variability of fasting blood glucose (FBG)

End point description

FBG was measured by SMBG. Between-day glucose variability is measured by the standard deviation (SD) of FBG. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline SD of FBG as the fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

26 weeks and 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	639	437
Units: mg/dL
least squares mean (standard error)
Week 26	51.7 ± 1.22	64.73 ± 1.44
Week 52	53.97 ± 1.24	63.11 ± 1.46

No statistical analyses for this end point

Secondary: Fasting blood glucose (by participant self monitored blood glucose readings)

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End point title

Fasting blood glucose (by participant self monitored blood glucose readings)

End point description

Fasting blood glucose (FBG) was measured by SMBG pre-morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline FBG as the fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

26 weeks and 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	643	441
Units: mg/dL
least squares mean (standard error)
Week 26	154.84 ± 1.96	151.46 ± 2.31
Week 52	159.85 ± 2.02	153.09 ± 2.39

No statistical analyses for this end point

Secondary: Triglycerides, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and total cholesterol

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End point title

Triglycerides, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and total cholesterol

End point description

Concentrations of cholesterol, HDL-C, and LDL-C, and triglycerides are presented. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L), except for the LDL-C outcome variable], prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable as the fixed effects and participant as a random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

26 weeks and 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	650	446
Units: mg/dL
least squares mean (standard error)
Cholesterol, Week 26	185.51 ± 1.09	179.3 ± 1.29
Cholesterol, Week 52	184.66 ± 1.13	178.13 ± 1.34
HDL-C, Week 26	58.44 ± 0.39	61.52 ± 0.46
HDL-C, Week 52	58.13 ± 0.39	59.52 ± 0.46
LDL-C, Week 26	106.25 ± 0.9	100.9 ± 1.07
LDL-C, Week 52	105.8 ± 0.96	101.2 ± 1.14
Triglycerides, Week 26	105.26 ± 2.3	85.11 ± 2.73
Triglycerides, Week 52	104.84 ± 2.17	88.12 ± 2.57

No statistical analyses for this end point

Secondary: Percentage of Participants with Change in anti-LY2605541 antibodies

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End point title

Percentage of Participants with Change in anti-LY2605541 antibodies

End point description

The percentage of participants with anti-LY2605541 treatment-emergent antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.

End point type

Secondary

End point timeframe

26 weeks, 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	556	399
Units: percentage of participants
number (not applicable)
Week 26 (n=556, 399)	30.2	14
Week 52 (n=509, 363)	32.8	10.2

No statistical analyses for this end point

Secondary: Adult Low Blood Sugar Survey

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End point title

Adult Low Blood Sugar Survey

End point description

Low Blood Sugar Survey (LBSS) (also referenced as Hypoglycemia Fear Survey – II [HFS-II]) is a questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert-type scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), visit, treatment-by-visit interaction, and baseline LBSS score as the fixed effects and participant as the random effect. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.

End point type

Secondary

End point timeframe

26 weeks and 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	657	447
Units: units on a scale
least squares mean (standard error)
Week 26	29.48 ± 0.55	29.12 ± 0.65
Week 52	30.43 ± 0.59	29.27 ± 0.7

No statistical analyses for this end point

Secondary: Basal, meal time, and total insulin dose per body weight

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End point title

Basal, meal time, and total insulin dose per body weight

End point description

Basal insulin dose, meal-time insulin dose (short-acting bolus dose), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each postbaseline visit and stratification variables (baseline HbA1c [≤8.5% and> 8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], and baseline prior basal insulin therapy [insulin glargine/detemir/ other]) as fixed effects. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.

End point type

Secondary

End point timeframe

26 weeks and 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	551	392
Units: units/weight/day
least squares mean (standard error)
Basal insulin, Week 26 (n=527, 374)	0.46 ± 0.01	0.35 ± 0.01
Basal insulin, Week 52 (n=508, 367)	0.47 ± 0.01	0.35 ± 0.01
Meal time insulin, Week 26 (n=542, 388)	0.32 ± 0.01	0.44 ± 0.01
Meal time insulin, Week 52 (n=490, 352)	0.33 ± 0.01	0.43 ± 0.01
Total insulin, Week 26 (n=551, 392)	0.75 ± 0.01	0.77 ± 0.01
Total insulin, Week 52 (n=509, 369)	0.78 ± 0.01	0.77 ± 0.02

No statistical analyses for this end point

Secondary: Insulin Treatment Satisfaction Questionnaire

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End point title

Insulin Treatment Satisfaction Questionnaire

End point description

Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated measure containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Convenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data are transformed to a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an ANCOVA model adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, and baseline prior basal insulin therapy (insulin glargine/detemir/other) as fixed effects and baseline ITSQ scores as a covariate. Analysis Population Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.

End point type

Secondary

End point timeframe

up to 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	561	406
Units: units on a scale
least squares mean (standard error)	73.6 ± 0.57	72.92 ± 0.67

No statistical analyses for this end point

Secondary: European Quality of Life -5 dimension (EQ-5D-3L)

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End point title

European Quality of Life -5 dimension (EQ-5D-3L)

End point description

EQ-5D-3L, a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an ANCOVA adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), and baseline EQ-5D-3L score as covariates. Analysis Population Description:Participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D-3L data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.

End point type

Secondary

End point timeframe

up to 52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	566	406
Units: units on a scale
least squares mean (standard error)	0.91 ± 0	0.92 ± 0.01

No statistical analyses for this end point

Secondary: Rapid Assessment of Physical Activity (RAPA)

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End point title

Rapid Assessment of Physical Activity (RAPA)

End point description

RAPA assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: 1 (Aerobic) and 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant’s amount and intensity of physical activity, allowing each participant’s aerobic activity level to be categorized as sedentary, underactive, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants’ physical activities that increase strength and improve flexibility. Each participant’s strength and flexibility activity level is then categorized as neither strength nor flexible, either strength or flexible (not both), both strength and flexible. The % of participants in each RAPA 1/2 category was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, multiplied by 100. Participants who were randomized, had at least 1 dose of study medication, and had evaluable RAPA data.

End point type

Secondary

End point timeframe

52 weeks

End point values	LY2605541 + Insulin Lispro	Insulin Glargine + Insulin Lispro
Number of subjects analysed	367	254
Units: percentage of participants
number (not applicable)
RAPA 1, Sedentary (n=364, 249)	1.1	1.2
RAPA 1, Underactive (n=364, 249)	3.8	4.8
RAPA 1, Light activity (n=364, 249)	13.7	14.5
RAPA 1, Regular underactive (n=364, 249)	24.5	28.5
RAPA 1, Active (n=364, 249)	56.9	51
RAPA 2, Neither strength/flexibility (n=367, 254)	39	46.9
RAPA 2, Either strength/flexibility (n=367, 254)	28.9	26.8
RAPA 2, Both strength/flexibility (n=367, 254)	32.2	26.4

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Analysis Period 2 (AP2)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.0

Reporting group title

Glargine + Insulin Lispro

Reporting group description

Reporting group title

LY2605541 + Insulin Lispro

Reporting group description

Serious adverse events	Glargine + Insulin Lispro	LY2605541 + Insulin Lispro
Total subjects affected by serious adverse events
subjects affected / exposed	92 / 449 (20.49%)	117 / 663 (17.65%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adenocarcinoma gastric
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
basal cell carcinoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
benign hydatidiform mole
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
bladder papilloma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cerebellopontine angle tumour
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
intraductal proliferative breast lesion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
non-small cell lung cancer metastatic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal carcinoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
squamous cell carcinoma of the tongue
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
uterine leiomyoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
haemorrhage
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral ischaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
hyperemesis gravidarum
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pregnancy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
pyrexia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
drug hypersensitivity
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
food allergy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
ovarian cyst
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
asthma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pleural effusion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
respiratory distress
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
acute psychosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
anxiety
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
major depression
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
suicide attempt
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
hepatic enzyme increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
liver function test abnormal
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
weight decreased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
accident at home
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
eye injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
fall
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
femur fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gun shot wound
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
hand fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
intentional overdose
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
radius fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
rib fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
road traffic accident
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
thermal burn
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
tibia fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
upper limb fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
wrist fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
acute myocardial infarction
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
angina pectoris
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
angina unstable
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
arteriosclerosis coronary artery
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cardiac failure
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
coronary artery disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
coronary artery occlusion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
myocardial infarction
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
cerebral infarction
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cerebrovascular accident
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
convulsion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
encephalopathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
epilepsy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
headache
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypoglycaemic seizure
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypoglycaemic unconsciousness
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences causally related to treatment / all	1 / 1	4 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
transient global amnesia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
transient ischaemic attack
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
autoimmune thrombocytopenia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lymphadenopathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
colitis microscopic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
constipation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
enteritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastric ulcer
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vomiting
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
cholelithiasis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
drug-induced liver injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
eczema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lipohypertrophy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences causally related to treatment / all	0 / 0	4 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
skin ulcer
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
urticaria
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
nephrotic syndrome
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
back pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lumbar spinal stenosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
neuropathic arthropathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
osteoarthritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
abscess limb
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
abscess oral
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
appendicitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cellulitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
gastritis viral
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastroenteritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lobar pneumonia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
osteomyelitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
pyelonephritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
sepsis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
viraemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
dehydration
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic ketoacidosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	6 / 449 (1.34%)	3 / 663 (0.45%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
hyperglycaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	1 / 663 (0.15%)
occurrences causally related to treatment / all	2 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypoglycaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	58 / 449 (12.92%)	71 / 663 (10.71%)
occurrences causally related to treatment / all	81 / 95	84 / 108
deaths causally related to treatment / all	0 / 0	0 / 0
ketoacidosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0

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

Non-serious adverse events	Glargine + Insulin Lispro	LY2605541 + Insulin Lispro
Total subjects affected by non serious adverse events
subjects affected / exposed	305 / 449 (67.93%)	502 / 663 (75.72%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
haemangioma of liver
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
lip neoplasm benign
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
lipoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	2	2
malignant melanoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
melanocytic naevus
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
prostatic adenoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
skin papilloma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
squamous cell carcinoma of skin
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Vascular disorders
aortic stenosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
arterial occlusive disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
arteriosclerosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
flushing
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
haematoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
hypertension
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	11 / 449 (2.45%)	11 / 663 (1.66%)
occurrences all number	11	12
intra-abdominal haematoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
orthostatic hypotension
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
peripheral arterial occlusive disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
phlebitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
spider vein
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
Surgical and medical procedures
acrochordon excision
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
artificial crown procedure
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
cataract operation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	3 / 663 (0.45%)
occurrences all number	4	4
cholecystectomy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
circumcision
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
coronary artery bypass
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
endodontic procedure
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
endometrial ablation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
eye laser surgery
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	4
fasciectomy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
female sterilisation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
gastric operation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
glaucoma surgery
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hysterectomy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
intraocular lens implant
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	2	0
knee arthroplasty
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
knee operation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
limb operation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	2
micrographic skin surgery
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
mole excision
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
myomectomy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
oral surgery
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
percutaneous coronary intervention
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
peripheral artery bypass
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
pilonidal sinus repair
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
plastic surgery
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
plastic surgery to the face
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
pleurodesis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
removal of foreign body from joint
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
shoulder operation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
tendon sheath incision
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
tendon sheath lesion excision
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
thoracotomy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
tonsillectomy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
tooth extraction
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	4 / 663 (0.60%)
occurrences all number	4	4
vasectomy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
wisdom teeth removal
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	1 / 663 (0.15%)
occurrences all number	3	1
Pregnancy, puerperium and perinatal conditions
pregnancy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
General disorders and administration site conditions
application site erythema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
application site pruritus
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
asthenia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	3 / 663 (0.45%)
occurrences all number	3	3
atrophy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
chest discomfort
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
chest pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	1 / 663 (0.15%)
occurrences all number	3	1
chills
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
cyst
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
discomfort
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
early satiety
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
fat tissue increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
fatigue
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	8 / 449 (1.78%)	10 / 663 (1.51%)
occurrences all number	8	11
feeling hot
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
feeling jittery
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hernia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hyperthermia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	3
implant site pruritus
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
induration
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
inflammation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
inflammatory pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	2
influenza like illness
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	7 / 663 (1.06%)
occurrences all number	6	7
infusion site erythema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
infusion site hypertrophy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	3
injection site atrophy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
injection site bruising
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	3
injection site erythema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
injection site haematoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
injection site haemorrhage
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
injection site hypertrophy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	16 / 663 (2.41%)
occurrences all number	0	20
injection site induration
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	3
injection site inflammation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
injection site mass
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	3
injection site oedema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	4
injection site pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
injection site reaction
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	5 / 663 (0.75%)
occurrences all number	0	5
injection site swelling
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	13 / 663 (1.96%)
occurrences all number	0	15
local swelling
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
localised oedema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
malaise
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	3
mass
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
medical device site reaction
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
nodule
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
non-cardiac chest pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
oedema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
oedema peripheral
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	13 / 663 (1.96%)
occurrences all number	5	17
pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	2 / 663 (0.30%)
occurrences all number	2	2
puncture site swelling
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
pyrexia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	8 / 449 (1.78%)	10 / 663 (1.51%)
occurrences all number	9	10
swelling
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	2
thrombosis in device
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
vessel puncture site pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Immune system disorders
allergy to chemicals
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
anaphylactic reaction
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
food allergy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hypersensitivity
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	2	1
seasonal allergy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	5 / 663 (0.75%)
occurrences all number	2	5
Reproductive system and breast disorders
breast mass
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	4
breast pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
diabetic mastopathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
dysmenorrhoea
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	3 / 663 (0.45%)
occurrences all number	3	3
endometriosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
menopausal symptoms
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
menorrhagia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
menstrual disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
metrorrhagia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
ovarian cyst
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
polycystic ovaries
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
prostatitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
rectocele
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
scrotal pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
vaginal haemorrhage
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
vulval disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Respiratory, thoracic and mediastinal disorders
asthma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	3	1
atelectasis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
cough
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	14 / 449 (3.12%)	31 / 663 (4.68%)
occurrences all number	15	32
dysphonia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
dyspnoea
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
emphysema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
epistaxis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
increased upper airway secretion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
lung infiltration
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
nasal congestion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	4 / 663 (0.60%)
occurrences all number	4	5
nasal septum deviation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
oropharyngeal pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	12 / 449 (2.67%)	14 / 663 (2.11%)
occurrences all number	12	15
productive cough
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	2 / 663 (0.30%)
occurrences all number	3	2
pulmonary oedema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
respiratory tract congestion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	3
restrictive pulmonary disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
rhinitis allergic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences all number	1	8
rhinorrhoea
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	1 / 663 (0.15%)
occurrences all number	3	1
sinus congestion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	5 / 663 (0.75%)
occurrences all number	5	5
upper respiratory tract congestion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
upper-airway cough syndrome
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
Psychiatric disorders
abnormal dreams
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
acute psychosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
affective disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
alcohol abuse
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
alcoholism
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
anxiety
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	8 / 663 (1.21%)
occurrences all number	3	8
anxiety disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
attention deficit/hyperactivity disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	1 / 663 (0.15%)
occurrences all number	3	1
bipolar disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
depression
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	6 / 449 (1.34%)	9 / 663 (1.36%)
occurrences all number	6	9
insomnia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	6 / 449 (1.34%)	4 / 663 (0.60%)
occurrences all number	6	4
major depression
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
mood swings
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
premature ejaculation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
psychotic disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
sleep disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
social phobia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
stress
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
Hepatobiliary disorders
cholecystitis chronic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
cholelithiasis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
hepatic steatosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences all number	1	4
hepatobiliary disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hepatotoxicity
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hypertransaminasaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Investigations
alanine aminotransferase increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	17 / 663 (2.56%)
occurrences all number	4	17
aspartate aminotransferase increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	7 / 663 (1.06%)
occurrences all number	4	7
biopsy skin
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
blood alkaline phosphatase increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	4 / 663 (0.60%)
occurrences all number	0	4
blood bilirubin increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	0 / 663 (0.00%)
occurrences all number	6	0
blood cholesterol increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
blood creatine phosphokinase increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	5 / 663 (0.75%)
occurrences all number	4	5
blood culture positive
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
blood glucose abnormal
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
blood glucose increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
blood potassium increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
blood testosterone decreased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
blood thyroid stimulating hormone decreased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
blood triglycerides increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
cardiac murmur
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
carotid bruit
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
catheterisation cardiac
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
colonoscopy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
haematocrit increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
haemoglobin increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
heart rate irregular
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
hepatic enzyme increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	9 / 663 (1.36%)
occurrences all number	3	10
liver function test abnormal
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	8 / 663 (1.21%)
occurrences all number	5	8
pregnancy test positive
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
prostatic specific antigen increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
protein urine present
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	4 / 663 (0.60%)
occurrences all number	2	4
transaminases increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	4
troponin increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
urine ketone body present
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
vitamin d decreased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
weight decreased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	8 / 663 (1.21%)
occurrences all number	5	8
weight increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	6 / 449 (1.34%)	15 / 663 (2.26%)
occurrences all number	6	16
white blood cell count increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
white blood cells urine positive
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Injury, poisoning and procedural complications
animal bite
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	3
ankle fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	3	1
arthropod bite
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	1 / 663 (0.15%)
occurrences all number	3	1
arthropod sting
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
back injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
cartilage injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
clavicle fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
concussion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
contusion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	8 / 663 (1.21%)
occurrences all number	2	9
corneal abrasion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
epicondylitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
excoriation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences all number	1	4
face injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
facial bones fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
fall
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	2 / 663 (0.30%)
occurrences all number	2	2
fascial rupture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
foot fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	4 / 663 (0.60%)
occurrences all number	3	4
hand fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
humerus fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
joint dislocation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
joint injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	2
laceration
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	5 / 663 (0.75%)
occurrences all number	2	6
ligament sprain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	7 / 663 (1.06%)
occurrences all number	4	9
limb injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	4 / 663 (0.60%)
occurrences all number	2	4
muscle injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
muscle strain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	5 / 663 (0.75%)
occurrences all number	3	5
overdose
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
patella fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
post-traumatic pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
procedural pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	4 / 663 (0.60%)
occurrences all number	3	4
rib fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
road traffic accident
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
skeletal injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
skin injury
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
subdural haematoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
sunburn
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
thermal burn
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	0 / 663 (0.00%)
occurrences all number	5	0
tooth fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	2 / 663 (0.30%)
occurrences all number	3	2
upper limb fracture
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
wound
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	4 / 663 (0.60%)
occurrences all number	2	4
Congenital, familial and genetic disorders
phimosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Cardiac disorders
angina pectoris
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	3
aortic valve incompetence
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
atrial fibrillation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
atrial flutter
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
bundle branch block left
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
cardiac failure congestive
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
cardiomegaly
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
mitral valve incompetence
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
mitral valve prolapse
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
palpitations
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	3
sinus bradycardia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	3 / 663 (0.45%)
occurrences all number	2	3
tachycardia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
tricuspid valve incompetence
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Nervous system disorders
autonomic nervous system imbalance
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
balance disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
burning sensation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
carpal tunnel syndrome
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	2 / 663 (0.30%)
occurrences all number	2	2
cerebrospinal fluid leakage
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
convulsion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
dementia alzheimer's type
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
diabetic neuropathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	5 / 663 (0.75%)
occurrences all number	2	5
dizziness
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	5 / 663 (0.75%)
occurrences all number	2	5
dizziness postural
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
dysgeusia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
headache
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	14 / 449 (3.12%)	24 / 663 (3.62%)
occurrences all number	21	37
hypoaesthesia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	12 / 663 (1.81%)
occurrences all number	1	14
lethargy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
lumbar radiculopathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
memory impairment
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
migraine
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	8 / 663 (1.21%)
occurrences all number	4	9
nerve compression
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
neuralgia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
neuritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
neuropathy peripheral
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	4 / 663 (0.60%)
occurrences all number	2	5
occipital neuralgia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
paraesthesia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	7 / 663 (1.06%)
occurrences all number	6	7
peroneal nerve palsy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
polyneuropathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
presyncope
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
radicular syndrome
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
restless legs syndrome
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
sciatica
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
sinus headache
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
syncope
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	2
tension headache
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
tremor
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
viith nerve paralysis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	2 / 663 (0.30%)
occurrences all number	4	2
anaemia of chronic disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
iron deficiency anaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
lymphadenitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
lymphadenopathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
normochromic normocytic anaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
pernicious anaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Ear and labyrinth disorders
auricular swelling
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
cerumen impaction
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
ear discomfort
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
ear pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
tinnitus
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
vertigo
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	3 / 663 (0.45%)
occurrences all number	3	3
Eye disorders
abnormal sensation in eye
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
asthenopia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
blepharitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
cataract
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	4
conjunctival haemorrhage
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
conjunctival hyperaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
conjunctivitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	2 / 663 (0.30%)
occurrences all number	5	2
diabetic retinopathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	6 / 449 (1.34%)	5 / 663 (0.75%)
occurrences all number	6	6
eye haemorrhage
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
eye irritation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
eye pruritus
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
eye swelling
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
glaucoma
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
lacrimation increased
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
macular oedema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
ocular hyperaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
pinguecula
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
retinal detachment
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
retinal haemorrhage
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
retinopathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
retinopathy proliferative
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
vision blurred
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	2 / 663 (0.30%)
occurrences all number	2	2
visual impairment
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
vitreous floaters
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
vitreous haemorrhage
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
Gastrointestinal disorders
abdominal discomfort
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	2 / 663 (0.30%)
occurrences all number	2	2
abdominal distension
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	6 / 663 (0.90%)
occurrences all number	0	6
abdominal mass
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	3
abdominal pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	7 / 663 (1.06%)
occurrences all number	5	8
abdominal pain lower
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
abdominal pain upper
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	7 / 663 (1.06%)
occurrences all number	6	7
aphthous stomatitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
coeliac disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	3
colitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
constipation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	10 / 663 (1.51%)
occurrences all number	3	10
dental caries
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences all number	1	4
diabetic gastroparesis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
diarrhoea
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	16 / 449 (3.56%)	14 / 663 (2.11%)
occurrences all number	17	16
dry mouth
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
dyspepsia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	5 / 663 (0.75%)
occurrences all number	5	5
dysphagia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
epigastric discomfort
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
flatulence
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
food poisoning
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	1 / 663 (0.15%)
occurrences all number	3	1
gastric dilatation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
gastric ulcer
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
gastritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
gastroduodenitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
gastrointestinal disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	2
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	6 / 449 (1.34%)	6 / 663 (0.90%)
occurrences all number	6	6
gingival bleeding
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
gingival disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
glossodynia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
haematochezia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
hiatus hernia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
impaired gastric emptying
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
inguinal hernia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
irritable bowel syndrome
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
lip swelling
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
nausea
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	17 / 449 (3.79%)	21 / 663 (3.17%)
occurrences all number	18	27
odynophagia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
oesophagitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
oesophageal achalasia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
oral disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
oral pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
paraesthesia oral
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
parotid duct obstruction
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
parotid gland inflammation
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
periodontal disease
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
rectal haemorrhage
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
tooth discolouration
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
toothache
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	7 / 663 (1.06%)
occurrences all number	2	8
umbilical hernia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
uvulitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
vomiting
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	16 / 449 (3.56%)	20 / 663 (3.02%)
occurrences all number	21	20
Skin and subcutaneous tissue disorders
actinic keratosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
alopecia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	4 / 663 (0.60%)
occurrences all number	0	4
blister
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	0 / 663 (0.00%)
occurrences all number	3	0
dermal cyst
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
dermatitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
dermatitis allergic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
dermatitis atopic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
dermatitis contact
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	4 / 663 (0.60%)
occurrences all number	2	4
diabetic cheiropathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
diabetic foot
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
dry skin
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
ecchymosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	3
eczema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	1 / 663 (0.15%)
occurrences all number	3	1
erythema
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hair texture abnormal
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hyperhidrosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hyperkeratosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
hypertrichosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
ingrowing nail
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
lichen planus
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
lipoatrophy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
lipodystrophy acquired
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	8 / 663 (1.21%)
occurrences all number	0	10
lipohypertrophy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	55 / 663 (8.30%)
occurrences all number	1	69
nail disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
night sweats
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
peau d'orange
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
pityriasis rosea
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
precancerous skin lesion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
pruritus
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	6 / 663 (0.90%)
occurrences all number	2	7
pruritus allergic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
pruritus generalised
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
psoriasis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
rash
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	9 / 663 (1.36%)
occurrences all number	4	10
rash pruritic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
scab
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
skin hypertrophy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
skin induration
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
skin lesion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
skin mass
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
skin striae
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
skin ulcer
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
urticaria
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences all number	1	5
Renal and urinary disorders
dysuria
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
haematuria
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	3 / 663 (0.45%)
occurrences all number	2	3
pollakiuria
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	2 / 663 (0.30%)
occurrences all number	2	2
proteinuria
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
renal colic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
renal failure
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
renal failure acute
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
renal failure chronic
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
renal impairment
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
urinary incontinence
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
urinary retention
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Endocrine disorders
hyperparathyroidism
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hypogonadism
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hypothyroidism
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
secondary hypogonadism
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	10 / 449 (2.23%)	14 / 663 (2.11%)
occurrences all number	12	15
arthritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	3 / 663 (0.45%)
occurrences all number	2	4
back pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	6 / 449 (1.34%)	8 / 663 (1.21%)
occurrences all number	7	8
bone pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
bursitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
chondropathy
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
coccydynia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	2
costochondritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
exostosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
fibromyalgia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
flank pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
gouty arthritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
groin pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
intervertebral disc protrusion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
intervertebral disc space narrowing
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
joint stiffness
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
joint swelling
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	3
lateral patellar compression syndrome
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	2
lumbar spinal stenosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
muscle spasms
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	8 / 663 (1.21%)
occurrences all number	3	9
muscular weakness
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
musculoskeletal chest pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	3
musculoskeletal pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	8 / 449 (1.78%)	8 / 663 (1.21%)
occurrences all number	8	11
myalgia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	6 / 449 (1.34%)	7 / 663 (1.06%)
occurrences all number	7	8
myositis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
neck pain
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences all number	1	5
osteoarthritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
osteoporosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
pain in extremity
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	12 / 663 (1.81%)
occurrences all number	5	12
pain in jaw
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
periarthritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
plantar fasciitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences all number	1	5
rheumatoid arthritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
soft tissue disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
spinal column stenosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
synovial cyst
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	3
tendon disorder
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
tendonitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	2 / 663 (0.30%)
occurrences all number	3	2
tenosynovitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
torticollis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
trigger finger
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	3
Infections and infestations
abscess sweat gland
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
acute sinusitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	4 / 663 (0.60%)
occurrences all number	3	4
acute tonsillitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
atypical pneumonia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
bacterial infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	2	0
body tinea
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	3 / 663 (0.45%)
occurrences all number	0	3
borrelia infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
bronchitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	12 / 449 (2.67%)	16 / 663 (2.41%)
occurrences all number	14	17
bronchopneumonia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
burn infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
candidiasis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
cellulitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	3 / 663 (0.45%)
occurrences all number	4	3
chlamydial infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
conjunctivitis infective
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
cystitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
dengue fever
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
dermatitis infected
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
diverticulitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
ear infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	6 / 663 (0.90%)
occurrences all number	4	7
erythema migrans
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
eye infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
eye infection bacterial
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
folliculitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	5
fungal infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	3 / 663 (0.45%)
occurrences all number	5	3
furuncle
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
gastritis viral
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	2
gastroenteritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	11 / 449 (2.45%)	12 / 663 (1.81%)
occurrences all number	14	15
gastroenteritis viral
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	15 / 449 (3.34%)	18 / 663 (2.71%)
occurrences all number	15	18
gingival abscess
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
gingival infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
hepatitis c
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
herpes simplex
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
herpes zoster
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	5 / 663 (0.75%)
occurrences all number	4	5
infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
infectious pleural effusion
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
influenza
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	22 / 449 (4.90%)	45 / 663 (6.79%)
occurrences all number	23	47
kidney infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
labyrinthitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
laryngitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
localised infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	8 / 663 (1.21%)
occurrences all number	1	8
lower respiratory tract infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	6 / 663 (0.90%)
occurrences all number	4	6
mononucleosis syndrome
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
nasal abscess
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
nasopharyngitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	70 / 449 (15.59%)	105 / 663 (15.84%)
occurrences all number	99	141
onychomycosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	3 / 663 (0.45%)
occurrences all number	2	3
oral candidiasis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
oral herpes
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	4 / 449 (0.89%)	2 / 663 (0.30%)
occurrences all number	4	2
otitis externa
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
otitis media
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	1 / 663 (0.15%)
occurrences all number	1	1
paronychia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
pharyngitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	8 / 449 (1.78%)	6 / 663 (0.90%)
occurrences all number	9	6
pharyngitis streptococcal
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	5 / 663 (0.75%)
occurrences all number	3	6
pneumonia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	2 / 663 (0.30%)
occurrences all number	5	2
post procedural infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
postoperative wound infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
pulpitis dental
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	2	0
respiratory tract infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences all number	1	4
respiratory tract infection viral
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
rhinitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	3
rhinovirus infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
rotavirus infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
sinusitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	14 / 449 (3.12%)	29 / 663 (4.37%)
occurrences all number	19	33
skin infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	1 / 663 (0.15%)
occurrences all number	3	1
soft tissue infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
staphylococcal infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
staphylococcal skin infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
subcutaneous abscess
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
syphilis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
tinea cruris
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
tinea pedis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
tonsillitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	6 / 663 (0.90%)
occurrences all number	1	6
tooth abscess
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	9 / 663 (1.36%)
occurrences all number	5	9
tooth infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	6 / 663 (0.90%)
occurrences all number	3	7
tracheitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
tracheobronchitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
upper respiratory tract infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	40 / 449 (8.91%)	61 / 663 (9.20%)
occurrences all number	52	76
urethritis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
urinary tract infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	15 / 449 (3.34%)	24 / 663 (3.62%)
occurrences all number	18	28
vaginal infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
vaginitis bacterial
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
viral diarrhoea
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
viral infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	12 / 449 (2.67%)	7 / 663 (1.06%)
occurrences all number	12	9
viral pharyngitis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
viral upper respiratory tract infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	3 / 449 (0.67%)	5 / 663 (0.75%)
occurrences all number	3	5
vulvovaginal candidiasis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	4 / 663 (0.60%)
occurrences all number	1	4
vulvovaginal mycotic infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
wound infection
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
Metabolism and nutrition disorders
abnormal loss of weight
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
decreased appetite
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	5 / 663 (0.75%)
occurrences all number	0	5
decreased insulin requirement
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
dehydration
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	2	0
diabetes mellitus inadequate control
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
diabetic ketoacidosis
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
dyslipidaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	2 / 663 (0.30%)
occurrences all number	1	2
fluid retention
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
gout
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	1 / 663 (0.15%)
occurrences all number	2	1
hypercalcaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hypercholesterolaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	5 / 663 (0.75%)
occurrences all number	0	5
hyperglycaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	5 / 449 (1.11%)	2 / 663 (0.30%)
occurrences all number	5	2
hyperlipidaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
hypertriglyceridaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	5 / 663 (0.75%)
occurrences all number	0	6
hypocalcaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
hypokalaemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	2 / 449 (0.45%)	0 / 663 (0.00%)
occurrences all number	3	0
hyponatraemia
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
iron deficiency
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	1 / 663 (0.15%)
occurrences all number	0	1
obesity
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	0 / 449 (0.00%)	2 / 663 (0.30%)
occurrences all number	0	2
overweight
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	0 / 663 (0.00%)
occurrences all number	1	0
vitamin d deficiency
alternative dictionary used: MedDRA 16.0
subjects affected / exposed	1 / 449 (0.22%)	3 / 663 (0.45%)
occurrences all number	1	3

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Hemoglobin A1c (HbA1c)

Primary: Hemoglobin A1c (HbA1c)

Secondary: Hemoglobin A1c (HbA1c)

Secondary: Hemoglobin A1c (HbA1c)

Secondary: Total hypoglycemia events

Secondary: Total hypoglycemia events

Secondary: Change from baseline to 52 weeks in HbA1c

Secondary: Change from baseline to 52 weeks in HbA1c

Secondary: Percentage of participants with HbA1c equal to or less than 6.5% and less than 7.0%

Secondary: Percentage of participants with HbA1c equal to or less than 6.5% and less than 7.0%

Secondary: Percentage of participants with total hypoglycemic events

Secondary: Percentage of participants with total hypoglycemic events

Secondary: Change in body weight

Secondary: Change in body weight

Secondary: Percentage of participants with nocturnal hypoglycemic events

Secondary: Percentage of participants with nocturnal hypoglycemic events

Secondary: Nocturnal Hypoglycemia Rates

Secondary: Nocturnal Hypoglycemia Rates

Secondary: Percentage of participants with HbA1c less than 7.0% and without nocturnal hypoglycemia

Secondary: Percentage of participants with HbA1c less than 7.0% and without nocturnal hypoglycemia

Secondary: Fasting serum glucose (by laboratory measurement)

Secondary: Fasting serum glucose (by laboratory measurement)

Secondary: 9 point self-monitored blood glucose (SMBG)

Secondary: 9 point self-monitored blood glucose (SMBG)

Secondary: 0300 hours blood glucose (BG) to fasting BG excursion

Secondary: 0300 hours blood glucose (BG) to fasting BG excursion

Secondary: Intra-participant variability of fasting blood glucose (FBG)

Secondary: Intra-participant variability of fasting blood glucose (FBG)

Secondary: Fasting blood glucose (by participant self monitored blood glucose readings)

Secondary: Fasting blood glucose (by participant self monitored blood glucose readings)

Secondary: Triglycerides, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and total cholesterol

Secondary: Triglycerides, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and total cholesterol

Secondary: Percentage of Participants with Change in anti-LY2605541 antibodies

Secondary: Percentage of Participants with Change in anti-LY2605541 antibodies

Secondary: Adult Low Blood Sugar Survey

Secondary: Adult Low Blood Sugar Survey

Secondary: Basal, meal time, and total insulin dose per body weight

Secondary: Basal, meal time, and total insulin dose per body weight

Secondary: Insulin Treatment Satisfaction Questionnaire

Secondary: Insulin Treatment Satisfaction Questionnaire

Secondary: European Quality of Life -5 dimension (EQ-5D-3L)

Secondary: European Quality of Life -5 dimension (EQ-5D-3L)

Secondary: Rapid Assessment of Physical Activity (RAPA)

Secondary: Rapid Assessment of Physical Activity (RAPA)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study