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Clinical Trial Results:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events

Summary
EudraCT number	2011-001732-37
Trial protocol	HU CZ SK DE EE LT LV GB IT BG PL
Global end of trial date	05 May 2014

Results information
Results version number	v1(current)
This version publication date	04 Mar 2016
First version publication date	31 Jul 2015
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

TAK-875_306

ISRCTN number

-

US NCT number

NCT01609582

WHO universal trial number (UTN)

U1111-1129-7824

Sponsor organisation name

Takeda

Sponsor organisation address

61 Aldwych, London, United Kingdom, WC2B 4AE

Public contact

Program Manager, Takeda Global Research & Development Centre (Europe) Ltd., 0044 0203116 8000, clinicaloperations@tgrd.com

Scientific contact

Program Manager, Takeda Global Research & Development Centre (Europe) Ltd., 0044 0203116 8000, clinicaloperations@tgrd.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

19 Dec 2014

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

05 May 2014

Was the trial ended prematurely?

Yes

Main objective of the trial

The primary objective is to demonstrate that no excess risk of cardiovascular (CV) composite events exists following treatment with TAK-875 (fasiglifam) compared with placebo when given in combination with Standard of Care in subjects with type 2 diabetes mellitus (T2DM) and clinically evident CV disease or multiple risk factors for CV events. For purposes of this study, the primary major adverse cardiovascular events (MACE) composite comprises CV death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).

Protection of trial subjects

All study subjects were required to read and sign an Informed Consent Form.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

01 Jun 2012

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Slovakia: 62

Country: Number of subjects enrolled

Poland: 236

Country: Number of subjects enrolled

United Kingdom: 32

Country: Number of subjects enrolled

Bulgaria: 43

Country: Number of subjects enrolled

Czech Republic: 112

Country: Number of subjects enrolled

Estonia: 24

Country: Number of subjects enrolled

Germany: 60

Country: Number of subjects enrolled

Hungary: 146

Country: Number of subjects enrolled

Italy: 6

Country: Number of subjects enrolled

Latvia: 22

Country: Number of subjects enrolled

Lithuania: 30

Country: Number of subjects enrolled

Argentina: 242

Country: Number of subjects enrolled

Australia: 69

Country: Number of subjects enrolled

Canada: 211

Country: Number of subjects enrolled

Croatia: 33

Country: Number of subjects enrolled

France: 7

Country: Number of subjects enrolled

Hong Kong: 58

Country: Number of subjects enrolled

Israel: 51

Country: Number of subjects enrolled

Korea, Republic of: 56

Country: Number of subjects enrolled

Malaysia: 61

Country: Number of subjects enrolled

Mexico: 52

Country: Number of subjects enrolled

New Zealand: 40

Country: Number of subjects enrolled

Peru: 35

Country: Number of subjects enrolled

Philippines: 49

Country: Number of subjects enrolled

Romania: 9

Country: Number of subjects enrolled

Russian Federation: 48

Country: Number of subjects enrolled

South Africa: 20

Country: Number of subjects enrolled

Taiwan: 62

Country: Number of subjects enrolled

Thailand: 61

Country: Number of subjects enrolled

Ukraine: 152

Country: Number of subjects enrolled

United States: 1118

Worldwide total number of subjects

3207

EEA total number of subjects

822

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

1645

From 65 to 84 years

1543

85 years and over

19

Subject disposition

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Recruitment details

Subjects took part in the study at 469 investigative sites in 31 countries; 192 sites in North America, 175 in the Europe, Middle East, and Africa (EMEA) region (including Russia, Ukraine, Israel, and South Africa), 65 in the Asia Pacific region, and 37 in Latin/South America from 01 June 2012 to 05 May 2014.

Screening details

Subjects with a historical diagnosis of T2DM and clinically-evident CV disease or multiple risk factors for CV events who were inadequately controlled while receiving the standard of care were enrolled in 1 of 2 treatment groups: placebo; fasiglifam 50 milligram (mg).

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.

Fasiglifam 50 mg

Arm description

Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.

Arm type

Experimental

Investigational medicinal product name

Fasiglifam

Investigational medicinal product code

Other name

TAK-875

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.

Number of subjects in period 1	Placebo	Fasiglifam 50 mg
Started	1603	1604
Treated	1603	1601
Completed	0	0
Not completed	1603	1604
Randomized, but not treated	-	3
Other	9	10
Adverse event	20	18
Study terminated by sponsor	1543	1548
Lost to follow-up	10	10
Withdrawal by subject	21	15

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.

Reporting group title

Fasiglifam 50 mg

Reporting group description

Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.

Reporting group values	Placebo	Fasiglifam 50 mg	Total
Number of subjects	1603	1604	3207
Age categorical
Units: Subjects
Less than (<) 65 years	794	851	1645
Greater than or equal to (>=) 65 years	809	753	1562
Age continuous
Units: years
arithmetic mean (standard deviation)	63.9 ( 9.03 )	63.4 ( 9.2 )	-
Gender categorical
Units: Subjects
Female	543	563	1106
Male	1060	1041	2101
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	150	119	269
Not Hispanic or Latino	446	477	923
Unknown or Not Reported	1007	1008	2015
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	47	41	88
Asian	199	205	404
Native Hawaiian or Other Pacific Islander	6	7	13
Black or African American	79	95	174
White	1265	1246	2511
Multiracial/More than 1 race	7	10	17
Glycosylated Hemoglobin (HbA1c) Category
Units: Subjects
<8.5 percent (%)	988	936	1924
>=8.5%	615	668	1283
Smoking Classification
Units: Subjects
Never smoked	667	668	1335
Current smoker	330	328	658
Ex-smoker	606	608	1214
Region of Enrollment
Units: Subjects
Argentina	121	121	242
Australia	34	35	69
Bulgaria	21	22	43
Canada	104	107	211
Croatia	16	17	33
Czech Republic	56	56	112
Estonia	13	11	24
France	3	4	7
Germany	30	30	60
Hong Kong	29	29	58
Hungary	74	72	146
Israel	25	26	51
Italy	3	3	6
Korea, Republic of	29	27	56
Latvia	11	11	22
Lithuania	15	15	30
Malaysia	30	31	61
Mexico	26	26	52
New Zealand	20	20	40
Peru	18	17	35
Philippines	25	24	49
Poland	118	118	236
Romania	5	4	9
Russian Federation	25	23	48
Slovakia	31	31	62
South Africa	10	10	20
Taiwan, Province of China	31	31	62
Thailand	29	32	61
Ukraine	76	76	152
United Kingdom	16	16	32
United States	559	559	1118
Height
For this outcome measure, number of subjects evaluable were 1598 and 1597 for each arm, respectively.
Units: centimeter (cm)
arithmetic mean (standard deviation)	168.1 ( 9.84 )	167.6 ( 10.54 )	-
Weight
Units: kilogram (kg)
arithmetic mean (standard deviation)	91.14 ( 19.832 )	91.4 ( 21.319 )	-
Body Mass Index (BMI)
For this outcome measure, number of subjects evaluable were 1598 and 1597 for each arm, respectively.
Units: kilogram per square meter (kg/m^2)
arithmetic mean (standard deviation)	32.14 ( 6.107 )	32.45 ( 7.497 )	-
Duration of Diabetes
For this outcome measure, number of subjects evaluable were 1602 and 1602 for each arm, respectively.
Units: years
arithmetic mean (standard deviation)	13.583 ( 8.409 )	13.333 ( 8.321 )	-

End points

Top of page

Reporting group title

Placebo

Reporting group description

Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.

Reporting group title

Fasiglifam 50 mg

Reporting group description

Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.

Primary: Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite

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End point title

Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite ^[1]

End point description

The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization). Full Analysis Set (FAS) included all randomized subjects who had baseline and at least 1 post-baseline assessment. Here, '99999' reported for median and 95% confidence interval (CI) signifies not estimable. Median time and corresponding 95% confidence interval could not be reached since very low number of participants (<50%) had event related to any component of primary MACE composite.

End point type

Primary

End point timeframe

Baseline up to end of study (up to Day 588)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Median time and associated confidence interval could not be reached for any treatment group. Hence, comparative statistics could not be performed.

End point values	Placebo	Fasiglifam 50 mg
Number of subjects analysed	1603	1604
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite

Top of page

End point title

Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite

End point description

The time from randomization to the first occurrences of any event in the secondary MACE composite was evaluated using Kaplan-Meier analysis. The secondary MACE composite comprised CV death, nonfatal MI, and nonfatal stroke. FAS included all randomized subjects who had baseline and at least 1 post-baseline assessment. Here, '99999' reported for median and 95% CI signifies not estimable. Median time and corresponding 95% confidence interval could not be reached since very low number of participants (<50%) had event related to any component of secondary MACE composite.

End point type

Secondary

End point timeframe

Baseline up to end of study (up to Day 588)

End point values	Placebo	Fasiglifam 50 mg
Number of subjects analysed	1603	1604
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.

Adverse event reporting additional description

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the subject or observed by the investigator was recorded, irrespective of the relation to study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

Placebo

Reporting group description

Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.

Reporting group title

Fasiglifam 50 mg

Reporting group description

Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.

Serious adverse events	Placebo	Fasiglifam 50 mg
Total subjects affected by serious adverse events
subjects affected / exposed	197 / 1603 (12.29%)	201 / 1601 (12.55%)
number of deaths (all causes)	13	12
number of deaths resulting from adverse events	2	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer metastatic
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer stage IV
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatic cancer
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatocellular carcinoma
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine benign neoplasm
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Malignant melanoma
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic malignant melanoma
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastatic neoplasm
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic squamous cell carcinoma
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectosigmoid cancer
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Transitional cell carcinoma
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Accelerated hypertension
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	2 / 1603 (0.12%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Femoral artery occlusion
subjects affected / exposed	0 / 1603 (0.00%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 1603 (0.06%)	5 / 1601 (0.31%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	0 / 1603 (0.00%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	2 / 1603 (0.12%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	1 / 1603 (0.06%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	3 / 1603 (0.19%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vasculitis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Venous occlusion
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Coronary arterial stent insertion
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary revascularisation
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Foot amputation
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest discomfort
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	6 / 1603 (0.37%)	8 / 1601 (0.50%)
occurrences causally related to treatment / all	0 / 6	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Device malfunction
subjects affected / exposed	0 / 1603 (0.00%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Local swelling
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device pain
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	3 / 1603 (0.19%)	4 / 1601 (0.25%)
occurrences causally related to treatment / all	1 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden death
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Reproductive system and breast disorders
Prostatitis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	1 / 1603 (0.06%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	2 / 1603 (0.12%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 1603 (0.00%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleuritic pain
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary fibrosis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	2 / 1603 (0.12%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Delusion
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychogenic seizure
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Angiogram
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose increased
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram ST segment elevation
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accidental overdose
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	2 / 1603 (0.12%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	1 / 1603 (0.06%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laceration
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postpericardiotomy syndrome
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon injury
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic fracture
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (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 coronary syndrome
subjects affected / exposed	3 / 1603 (0.19%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	9 / 1603 (0.56%)	12 / 1601 (0.75%)
occurrences causally related to treatment / all	0 / 9	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 1
Angina pectoris
subjects affected / exposed	7 / 1603 (0.44%)	9 / 1601 (0.56%)
occurrences causally related to treatment / all	0 / 8	1 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	5 / 1603 (0.31%)	7 / 1601 (0.44%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	0 / 1603 (0.00%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Arteriosclerosis coronary artery
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	4 / 1603 (0.25%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	3 / 1603 (0.19%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	1 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	1 / 1603 (0.06%)	4 / 1601 (0.25%)
occurrences causally related to treatment / all	1 / 1	0 / 4
deaths causally related to treatment / all	1 / 1	0 / 4
Cardiac disorder
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	2 / 1603 (0.12%)	4 / 1601 (0.25%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	7 / 1603 (0.44%)	12 / 1601 (0.75%)
occurrences causally related to treatment / all	2 / 7	2 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	2 / 1603 (0.12%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Cardiogenic shock
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	7 / 1603 (0.44%)	6 / 1601 (0.37%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	0 / 1603 (0.00%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intracardiac thrombus
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	5 / 1603 (0.31%)	4 / 1601 (0.25%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	4 / 1603 (0.25%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	2 / 5	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Right ventricular failure
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (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
Carotid arteriosclerosis
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Central pain syndrome
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	7 / 1603 (0.44%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Ischaemic stroke
subjects affected / exposed	1 / 1603 (0.06%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	5 / 1603 (0.31%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Transient ischaemic attack
subjects affected / exposed	1 / 1603 (0.06%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
VIIth nerve paralysis
subjects affected / exposed	0 / 1603 (0.00%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 1603 (0.06%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 1603 (0.00%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic retinopathy
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal haemorrhage
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	0 / 1603 (0.00%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroduodenitis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	2 / 1603 (0.12%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	1 / 1603 (0.06%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal stenosis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic calcification
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	2 / 1603 (0.12%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	1 / 1603 (0.06%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	1 / 1603 (0.06%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	1 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	2 / 1603 (0.12%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	2 / 1603 (0.12%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic mass
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Blister
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	3 / 1603 (0.19%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nail bed inflammation
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Bladder prolapse
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus ureteric
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prerenal failure
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	4 / 1603 (0.25%)	6 / 1601 (0.37%)
occurrences causally related to treatment / all	2 / 4	3 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure acute
subjects affected / exposed	6 / 1603 (0.37%)	11 / 1601 (0.69%)
occurrences causally related to treatment / all	1 / 6	3 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure chronic
subjects affected / exposed	2 / 1603 (0.12%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal infarct
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Pituitary haemorrhage
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	0 / 1603 (0.00%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (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
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 1603 (0.06%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	2 / 1603 (0.12%)	6 / 1601 (0.37%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gangrene
subjects affected / exposed	1 / 1603 (0.06%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	1 / 1603 (0.06%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 1603 (0.06%)	4 / 1601 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal viral infection
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infection
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paronychia
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	5 / 1603 (0.31%)	7 / 1601 (0.44%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumonia viral
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	2 / 1603 (0.12%)	3 / 1601 (0.19%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Staphylococcal bacteraemia
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal infection
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal urinary tract infection
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 1603 (0.06%)	2 / 1601 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	1 / 1603 (0.06%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	1 / 1603 (0.06%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
subjects affected / exposed	2 / 1603 (0.12%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	2 / 1603 (0.12%)	0 / 1601 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid overload
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	4 / 1603 (0.25%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	4 / 1603 (0.25%)	5 / 1601 (0.31%)
occurrences causally related to treatment / all	3 / 4	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	0 / 1603 (0.00%)	1 / 1601 (0.06%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Placebo	Fasiglifam 50 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	427 / 1603 (26.64%)	415 / 1601 (25.92%)
Vascular disorders
Hypertension
subjects affected / exposed	40 / 1603 (2.50%)	42 / 1601 (2.62%)
occurrences all number	40	43
Nervous system disorders
Dizziness
subjects affected / exposed	30 / 1603 (1.87%)	39 / 1601 (2.44%)
occurrences all number	31	45
Headache
subjects affected / exposed	32 / 1603 (2.00%)	41 / 1601 (2.56%)
occurrences all number	37	46
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	26 / 1603 (1.62%)	33 / 1601 (2.06%)
occurrences all number	26	34
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	48 / 1603 (2.99%)	44 / 1601 (2.75%)
occurrences all number	53	47
Nausea
subjects affected / exposed	35 / 1603 (2.18%)	33 / 1601 (2.06%)
occurrences all number	37	34
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	30 / 1603 (1.87%)	40 / 1601 (2.50%)
occurrences all number	34	43
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	36 / 1603 (2.25%)	41 / 1601 (2.56%)
occurrences all number	37	43
Infections and infestations
Bronchitis
subjects affected / exposed	45 / 1603 (2.81%)	49 / 1601 (3.06%)
occurrences all number	51	53
Influenza
subjects affected / exposed	37 / 1603 (2.31%)	34 / 1601 (2.12%)
occurrences all number	41	34
Nasopharyngitis
subjects affected / exposed	55 / 1603 (3.43%)	61 / 1601 (3.81%)
occurrences all number	62	69
Sinusitis
subjects affected / exposed	36 / 1603 (2.25%)	22 / 1601 (1.37%)
occurrences all number	44	26
Upper respiratory tract infection
subjects affected / exposed	87 / 1603 (5.43%)	75 / 1601 (4.68%)
occurrences all number	107	85
Urinary tract infection
subjects affected / exposed	43 / 1603 (2.68%)	35 / 1601 (2.19%)
occurrences all number	51	42

More information

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Were there any global substantial amendments to the protocol? Yes

30 Mar 2012

• Clarified that study drug could be temporarily suspended and reinitiated and that subjects who temporarily suspended or permanently discontinued study drug could continue in the study and follow the schedule of study procedures unless they explicitly withdrew consent; and to clarify options for continued study participation that were to be offered to subjects who voluntarily withdrew. • Tests for urine albumin, protein, and creatinine were changed from qualitative to quantitative to allow calculation of albumin/creatinine and protein/creatinine ratios

13 Nov 2012

• Indicated which subjects with elevated liver enzyme results or elevated liver enzyme and liver function test (LFT) results should be referred to a hepatologist, based on a recommendation from the German Central Ethics Committee.

03 Apr 2013

• Clarified that only abnormal liver enzyme results (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 times the upper limit of normal [ULN] in a subject with normal baseline ALT or AST; ALT or AST >5*ULN and 2-fold greater than baseline in a subject with elevated baseline ALT or AST) that occurred on 2 consecutive occasions were to be reported as an adverse event.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
26 Dec 2013	Following completion of the first phase 3 study (TAK-875_301), and after careful consideration of the data emerging from all the clinical studies and in consultation with the data monitoring committee (DMC), the Liver Safety Evaluation Committee, and the Executive Committee overseeing the fasiglifam CV outcomes trial (TAK-875_306), Takeda concluded that based on all available information, the benefits of treating subjects with fasiglifam do not outweigh the potential risks, thus Takeda decided voluntarily to terminate all development activities for fasiglifam based on liver safety concerns.	-

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

None reported

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