Clinical Trial Results:
A Phase 1/2 Multicenter Study of BMS-986012 in Subjects with Relapsed/Refractory Small Cell Lung Cancer

Clinical trials

Clinical Trial Results: A Phase 1/2 Multicenter Study of BMS-986012 in Subjects with Relapsed/Refractory Small Cell Lung Cancer

Clinical Trial Results:
A Phase 1/2 Multicenter Study of BMS-986012 in Subjects with Relapsed/Refractory Small Cell Lung Cancer

Trial information

Subject disposition

Baseline characteristics

End points

Adverse events

More information

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Adverse events

Adverse events

More information

More information

Primary: Number of Participants with Adverse Events (AEs)

Primary: Number of Participants with Serious Adverse Events (SAEs)

Primary: Number of Participants with Adverse Events (AEs) Leading to Discontinuation

Primary: Number of Participants Who Died

Primary: Number of Participants with Abnormal Hepatic Test

Secondary: BMS-986012 Maximum Observed Serum Concentration (Cmax)

Secondary: BMS-986012 Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))

Secondary: BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)

Secondary: BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)

Secondary: BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)

Secondary: BMS-986012 Total Body Clearance (CLT)

Secondary: BMS-986012 Trough Observed Serum Concentration (Ctrough)

Secondary: BMS-986012 Accumulation Index (AI_AUC)

Secondary: BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)

Secondary: BMS-986012 Ctau Accumulation Index (AI_Ctau)

Secondary: BMS-986012 Cmax Accumulation Index (AI_Cmax)

Secondary: Best Overall Response (BOR)

Secondary: BMS-986012 Effective Elimination (T-HALFeff)

Secondary: Duration of Response (DOR)

Secondary: Objective Response Rate (ORR)

Secondary: Progression Free Survival (PFS)

Secondary: Progression Free Survival Rate (PFSR)

Secondary: Number of Participants with Anti-BMS-986012 Antibodies (ADA)

Primary: Number of Participants with Adverse Events (AEs)

Primary: Number of Participants with Adverse Events (AEs)

Primary: Number of Participants with Serious Adverse Events (SAEs)

Primary: Number of Participants with Serious Adverse Events (SAEs)

Primary: Number of Participants with Adverse Events (AEs) Leading to Discontinuation

Primary: Number of Participants with Adverse Events (AEs) Leading to Discontinuation

Primary: Number of Participants Who Died

Primary: Number of Participants Who Died

Primary: Number of Participants with Abnormal Hepatic Test

Primary: Number of Participants with Abnormal Hepatic Test

Secondary: BMS-986012 Maximum Observed Serum Concentration (Cmax)

Secondary: BMS-986012 Maximum Observed Serum Concentration (Cmax)

Secondary: BMS-986012 Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))

Secondary: BMS-986012 Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))

Secondary: BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)

Secondary: BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)

Secondary: BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)

Secondary: BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)

Secondary: BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)

Secondary: BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)

Secondary: BMS-986012 Total Body Clearance (CLT)

Secondary: BMS-986012 Total Body Clearance (CLT)

Secondary: BMS-986012 Trough Observed Serum Concentration (Ctrough)

Secondary: BMS-986012 Trough Observed Serum Concentration (Ctrough)

Secondary: BMS-986012 Accumulation Index (AI_AUC)

Secondary: BMS-986012 Accumulation Index (AI_AUC)

Secondary: BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)

Secondary: BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)

Secondary: BMS-986012 Ctau Accumulation Index (AI_Ctau)

Secondary: BMS-986012 Ctau Accumulation Index (AI_Ctau)

Secondary: BMS-986012 Cmax Accumulation Index (AI_Cmax)

Secondary: BMS-986012 Cmax Accumulation Index (AI_Cmax)

Secondary: Best Overall Response (BOR)

Secondary: Best Overall Response (BOR)

Secondary: BMS-986012 Effective Elimination (T-HALFeff)

Secondary: BMS-986012 Effective Elimination (T-HALFeff)

Secondary: Duration of Response (DOR)

Secondary: Duration of Response (DOR)

Secondary: Objective Response Rate (ORR)

Secondary: Objective Response Rate (ORR)

Secondary: Progression Free Survival (PFS)

Secondary: Progression Free Survival (PFS)

Secondary: Progression Free Survival Rate (PFSR)

Secondary: Progression Free Survival Rate (PFSR)

Secondary: Number of Participants with Anti-BMS-986012 Antibodies (ADA)

Secondary: Number of Participants with Anti-BMS-986012 Antibodies (ADA)

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Summary
EudraCT number	2014-002372-89
Trial protocol	BE NL
Global end of trial date	21 Dec 2022

Results information
Results version number	v1(current)
This version publication date	04 Jan 2024
First version publication date	04 Jan 2024
Other versions

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

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Top of page

Sponsor protocol code

CA001-030

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussée de la Hulpe 185, Brussels, Belgium, 1170

Public contact

EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com

Scientific contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com

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

28 Feb 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

21 Dec 2022

Global end of trial reached?

Yes

Global end of trial date

21 Dec 2022

Was the trial ended prematurely?

Main objective of the trial

To determine the multidose safety of BMS-986012 administered as monotherapy and in combination with nivolumab in subjects with relapsed/refractory small cell lung cancer (SCLC).

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

14 Nov 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 19

Country: Number of subjects enrolled

Belgium: 9

Country: Number of subjects enrolled

Canada: 46

Country: Number of subjects enrolled

Korea, Democratic People's Republic of: 3

Country: Number of subjects enrolled

Netherlands: 4

Country: Number of subjects enrolled

Puerto Rico: 2

Country: Number of subjects enrolled

United States: 23

Worldwide total number of subjects

106

EEA total number of subjects

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)

From 65 to 84 years

85 years and over

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Recruitment details

Screening details

106 participants treated

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

BMS 70mg

Arm description

70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Arm type

Experimental

Investigational medicinal product name

BMS-986012

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

70 mg every 21 days

BMS 160mg

Arm description

160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Arm type

Experimental

Investigational medicinal product name

BMS-986012

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

160 mg every 21 days

BMS 400mg

Arm description

400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Arm type

Experimental

Investigational medicinal product name

BMS-986012

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

400 mg every 21 days

BMS 1000mg

Arm description

1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Arm type

Experimental

Investigational medicinal product name

BMS-986012

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

1000 mg every 21 days

BMS 400mg + Nivo 360mg

Arm description

400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

360 mg every 21 days

Investigational medicinal product name

BMS-986012

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

400 mg every 21 days

BMS 1000mg + Nivo 360mg

Arm description

1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

360 mg every 21 days

Investigational medicinal product name

BMS-986012

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

1000 mg every 21 days

Number of subjects in period 1	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Started	7	6	29	35	21	8
Completed	0	0	0	0	0	0
Not completed	7	6	29	35	21	8
Adverse event, serious fatal	-	-	-	1	-	-
Consent withdrawn by subject	-	1	-	-	-	-
Adverse Event unrelated to study drug	-	-	-	-	1	-
Study drug toxicity	-	1	1	1	2	2
Other reasons	-	-	1	-	-	-
Disease Progression	7	4	26	31	16	6
Participant request to discontinue study treatment	-	-	1	2	1	-
Administrative reason by sponsor	-	-	-	-	1	-

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Reporting group title

BMS 70mg

Reporting group description

70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 160mg

Reporting group description

160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg

Reporting group description

400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 1000mg

Reporting group description

1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg + Nivo 360mg

Reporting group description

400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 1000mg + Nivo 360mg

Reporting group description

1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Reporting group values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg	Total
Number of subjects	7	6	29	35	21	8	106
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	65.1 ( 10.6 )	58.3 ( 8.1 )	64.4 ( 9.2 )	61.7 ( 9.5 )	62.1 ( 9.8 )	61.1 ( 7.3 )	-
Sex: Female, Male
Units: Participants
Female	4	4	11	12	9	5	45
Male	3	2	18	23	12	3	61
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	0	0	1	3	0	0	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	0	0	1	0	0	0	1
White	7	6	27	30	21	8	99
More than one race	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	2	0	0	2
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1	0	1	0	1	0	3
Not Hispanic or Latino	6	6	26	33	20	8	99
Unknown or Not Reported	0	0	2	2	0	0	4

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Reporting group title

BMS 70mg

Reporting group description

70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 160mg

Reporting group description

160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg

Reporting group description

400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 1000mg

Reporting group description

1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg + Nivo 360mg

Reporting group description

400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 1000mg + Nivo 360mg

Reporting group description

1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

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End point title

Number of Participants with Adverse Events (AEs) ^[1]

End point description

Number of participants with any grade adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

End point type

Primary

End point timeframe

From first dose to 100 days post last dose (Up to 64 months)

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: only summary statistics planned for this endpoint.

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7	6	29	35	21	8
Units: Participants	7	6	29	35	21	8

No statistical analyses for this end point

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End point title

Number of Participants with Serious Adverse Events (SAEs) ^[2]

End point description

Number of participants with any grade serious adverse events (SAEs). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: - results in death - is life-threatening - requires inpatient hospitalization or causes prolongation of existing hospitalization - results in persistent or significant disability/incapacity - is a congenital anomaly/birth defect - is an important medical event Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

End point type

Primary

End point timeframe

From first dose to 100 days post last dose (Up to 64 months)

Notes
[2] - 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: only summary statistics planned for this endpoint.

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7	6	29	35	21	8
Units: Participants	7	4	21	24	11	5

No statistical analyses for this end point

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End point title

Number of Participants with Adverse Events (AEs) Leading to Discontinuation ^[3]

End point description

Number of participants with any grade adverse events (AEs) leading to discontinuation. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

End point type

Primary

End point timeframe

From first dose to 100 days post last dose (Up to 64 months)

Notes
[3] - 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: only summary statistics planned for this endpoint.

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7	6	29	35	21	8
Units: Participants	0	1	2	5	3	2

No statistical analyses for this end point

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End point title

Number of Participants Who Died ^[4]

End point description

Number of participants who died due to any cause.

End point type

Primary

End point timeframe

From first dose to 100 days post last dose (Up to 64 months)

Notes
[4] - 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: only summary statistics planned for this endpoint.

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7	6	29	35	21	8
Units: Participants	3	2	10	16	2	4

No statistical analyses for this end point

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End point title

Number of Participants with Abnormal Hepatic Test ^[5]

End point description

Number of participants with laboratory abnormalities in specific hepatic tests. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: - ALT or AST > 5xULN, > 3xULN, and > 2xULN - Any of ALT, AST, Total Bilirubin or ALP > 8xULN - Total bilirubin > 3xULN ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal

End point type

Primary

End point timeframe

From first dose to 100 days post last dose (Up to 64 months)

Notes
[5] - 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: only summary statistics planned for this endpoint.

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7	6	29	35	21	8
Units: Participants
ALT OR AST > 5XULN	0	0	0	1	1	2
ALT OR AST > 3XULN	0	0	0	0	0	0
ALT OR AST > 2XULN	0	0	0	0	0	0
ANY OF ALT, AST, TOTAL BILIRUBIN OR ALP > 8XULN	0	0	0	1	0	1
TOTAL BILIRUBIN > 3XULN	1	0	0	0	0	1

No statistical analyses for this end point

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End point title

BMS-986012 Maximum Observed Serum Concentration (Cmax)

End point description

BMS-986012 maximum observed serum concentration (Cmax). '99999'=NA 'N'= Number of Subjects Analyzed

End point type

Secondary

End point timeframe

Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7 ^[6]	6 ^[7]	28 ^[8]	32 ^[9]	21 ^[10]	8 ^[11]
Units: ug/mL
geometric mean (geometric coefficient of variation)
cycle 1 day 1 (C1D1)	27.5 ( 31 )	53.8 ( 28 )	121 ( 26 )	276 ( 37 )	111 ( 33 )	339 ( 25 )
cycle 3 day 1 (C3D1)	33.8 ( 99999 )	46.9 ( 99999 )	221 ( 1 )	279 ( 37 )	99999 ( 99999 )	99999 ( 99999 )

Notes
[6] - C1D1 N=7 C3D1 N=1
[7] - C1D1 N=6 C3D1 N=1
[8] - C1D1 N=28 C3D1 N=2
[9] - C1D1 N=32 C3D1 N=3
[10] - C1D1 N=21 C3D1 N=0
[11] - C1D1 N=8 C3D1 N=0

No statistical analyses for this end point

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End point title

BMS-986012 Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))

End point description

BMS-986012 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)). '99999'=NA 'N'= Number of Subjects Analyzed

End point type

Secondary

End point timeframe

Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7 ^[12]	6 ^[13]	28 ^[14]	32 ^[15]	21 ^[16]	8 ^[17]
Units: h*ug/mL
geometric mean (geometric coefficient of variation)
cycle 1 day 1 (C1D1 )	3997 ( 31 )	5584 ( 55 )	18456 ( 32 )	36223 ( 40 )	16527 ( 31 )	45126 ( 24 )
cycle 3 day 1 (C3D1)	7062 ( 99999 )	10560 ( 99999 )	42583 ( 8 )	58649 ( 28 )	99999 ( 99999 )	99999 ( 99999 )

Notes
[12] - C1D1 N=7 C3D1 N=1
[13] - C1D1 N=6 C3D1 N=1
[14] - C1D1 N=28 C3D1 N=2
[15] - C1D1 N=32 C3D1 N=3
[16] - C1D1 N=21 C3D1 N=0
[17] - C1D1 N=8 C3D1 N=0

No statistical analyses for this end point

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End point title

BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)

End point description

BMS-986012 time of maximum observed serum concentration (Tmax). '99999'=NA 'N'= Number of Subjects Analyzed

End point type

Secondary

End point timeframe

Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7 ^[18]	6 ^[19]	28 ^[20]	32 ^[21]	21 ^[22]	8 ^[23]
Units: hours
median (full range (min-max))
cycle 1 day 1 (C1D1)	2.08 (1.00 to 8.00)	2.02 (1.00 to 6.33)	2.00 (1.00 to 6.07)	1.58 (0.950 to 4.40)	4.00 (1.00 to 5.40)	1.53 (1.00 to 4.30)
cycle 3 day 1 (C3D1)	1.93 (1.93 to 1.93)	4.00 (4.00 to 4.00)	2.04 (2.02 to 2.07)	2.30 (2.05 to 4.00)	99999 (99999 to 99999)	99999 (99999 to 99999)

Notes
[18] - C1D1 N=7 C3D1 N=1
[19] - C1D1 N=6 C3D1 N=1
[20] - C1D1 N=28 C3D1 N=2
[21] - C1D1 N=32 C3D1 N=3
[22] - C1D1 N=21 C3D1 N=0
[23] - C1D1 N=8 C3D1 N=0

No statistical analyses for this end point

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End point title

BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)

End point description

BMS-986012 area under the serum concentration-time curve in one dosing interval AUC (TAU). '99999'=NA 'N'= Number of Subjects Analyzed

End point type

Secondary

End point timeframe

Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7 ^[24]	5 ^[25]	26 ^[26]	28 ^[27]	17 ^[28]	6 ^[29]
Units: h*ug/mL
geometric mean (geometric coefficient of variation)
cycle 1 day 1 (C1D1)	4300 ( 29 )	8356 ( 28 )	19865 ( 28 )	40979 ( 34 )	18161 ( 30 )	49031 ( 26 )
cycle 3 day 1 (C3D1)	7062 ( 99999 )	10560 ( 99999 )	42583 ( 8 )	62634 ( 33 )	99999 ( 99999 )	99999 ( 99999 )

Notes
[24] - C1D1 N=7 C3D1 N=1
[25] - C1D1 N=5 C3D1 N=1
[26] - C1D1 N=26 C3D1 N=2
[27] - C1D1 N=28 C3D1 N=3
[28] - C1D1 N=17 C3D1 N=0
[29] - C1D1 N=6 C3D1 N=0

No statistical analyses for this end point

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End point title

BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)

End point description

BMS-986012 observed serum concentration at the end of a dosing interval (Ctau). '99999'=NA 'N'= Number of Subjects Analyzed

End point type

Secondary

End point timeframe

Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7 ^[30]	5 ^[31]	26 ^[32]	28 ^[33]	17 ^[34]	6 ^[35]
Units: ug/mL
geometric mean (geometric coefficient of variation)
cycle 1 day 1 (C1D1)	3.44 ( 38 )	6.24 ( 31 )	17.4 ( 32 )	30.2 ( 59 )	14.6 ( 44 )	39.5 ( 40 )
cycle 3 day 1 (C3D1)	7.39 ( 99999 )	13.6 ( 99999 )	42.4 ( 13 )	59.2 ( 19 )	99999 ( 99999 )	99999 ( 99999 )

Notes
[30] - C1D1 N=7 C3D1 N=1
[31] - C1D1 N=5 C3D1 N=1
[32] - C1D1 N=26 C3D1 N=2
[33] - C1D1 N=28 C3D1 N=3
[34] - C1D1 N=17 C3D1 N=0
[35] - C1D1 N=6 C3D1 N=0

No statistical analyses for this end point

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End point title

BMS-986012 Total Body Clearance (CLT)

End point description

BMS-986012 total body clearance (CLT). '99999'=NA 'N'= Number of Subjects Analyzed

End point type

Secondary

End point timeframe

Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7 ^[36]	5 ^[37]	26 ^[38]	28 ^[39]	17 ^[40]	6 ^[41]
Units: mL/h
geometric mean (geometric coefficient of variation)
cycle 1 day 1 (C1D1)	16.3 ( 38 )	19.1 ( 27 )	20.1 ( 24 )	24.4 ( 86 )	22.0 ( 30 )	20.4 ( 28 )
cycle 3 day 1 (C3D1)	9.91 ( 99999 )	15.2 ( 99999 )	9.39 ( 8 )	16.0 ( 40 )	99999 ( 99999 )	99999 ( 99999 )

Notes
[36] - C1D1 N=7 C3D1 N=1
[37] - C1D1 N=5 C3D1 N=1
[38] - C1D1 N=26 C3D1 N=2
[39] - C1D1 N=28 C3D1 N=3
[40] - C1D1 N=17 C3D1 N=0
[41] - C1D1 N=6 C3D1 N=0

No statistical analyses for this end point

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End point title

BMS-986012 Trough Observed Serum Concentration (Ctrough)

End point description

BMS-986012 trough observed serum concentration (Ctrough). '99999'=NA 'N'= Number of Subjects Analyzed

End point type

Secondary

End point timeframe

Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 7 day 1, cycle 11 day 1. cycle 15 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	4 ^[42]	4 ^[43]	22 ^[44]	18 ^[45]	13 ^[46]	5 ^[47]
Units: ng/mL
geometric mean (geometric coefficient of variation)
cycle 2 day 1 (C2D1)	4186 ( 27 )	7211 ( 17 )	18810 ( 29 )	36990 ( 54 )	14544 ( 84 )	36391 ( 43 )
cycle 3 day 1 (C3D1)	6570 ( 99999 )	9100 ( 99999 )	29232 ( 36 )	68589 ( 57 )	26016 ( 37 )	158801 ( 85 )
cycle 4 day 1 (C4D1)	7390 ( 99999 )	13600 ( 99999 )	35122 ( 26 )	90207 ( 68 )	26102 ( 63 )	157000 ( 99999 )
cycle 7 day 1 (C7D1)	9040 ( 99999 )	13700 ( 99999 )	38315 ( 27 )	107444 ( 58 )	38405 ( 9 )	99999 ( 99999 )
cycle 11 day 1 (C11D1)	9930 ( 99999 )	99999 ( 99999 )	32251 ( 14 )	102980 ( 67 )	34400 ( 99999 )	99999 ( 99999 )
cycle 15 day 1 (C15D1)	8029 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )

Notes
[42] - C2D1 N=4 C3D1 N=1 C4D1 N=1 C7D1 N=1 C11D1 N=1 C15D1 N=1
[43] - C2D1 N=4 C3D1 N=1 C4D1 N=1 C7D1 N=1 C11D1 N=0 C15D1 N=0
[44] - C2D1 N=22 C3D1 N=9 C4D1 N=6 C7D1 N=4 C11D1 N=2 C15D1 N=0
[45] - C2D1 N=18 C3D1 N=7 C4D1 N=5 C7D1 N=4 C11D1 N=2 C15D1 N=0
[46] - C2D1 N=13 C3D1 N=7 C4D1 N=6 C7D1 N=3 C11D1 N=1 C15D1 N=0
[47] - C2D1 N=5 C3D1 N=3 C4D1 N=1 C7D1 N=0 C11D1 N=0 C15D1 N=0

No statistical analyses for this end point

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End point title

BMS-986012 Accumulation Index (AI_AUC)

End point description

BMS-986012 accumulation index. Ratio of an exposure measure at steady state to that after the first dose. '99999'=NA

End point type

Secondary

End point timeframe

Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	1	1	2	2	0 ^[48]	0 ^[49]
Units: Ratio
geometric mean (geometric coefficient of variation)	1.56 ( 99999 )	1.55 ( 99999 )	1.62 ( 22 )	1.39 ( 51 )	( )	( )

Notes
[48] - 0 subjects analyzed
[49] - 0 subjects analyzed

No statistical analyses for this end point

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End point title

BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)

End point description

BMS-986012 Average concentration over a dosing interval ([AUC(TAU)/tau] (Css-avg). '99999'=NA

End point type

Secondary

End point timeframe

Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	1	1	2	3	0 ^[50]	0 ^[51]
Units: ug/mL
geometric mean (geometric coefficient of variation)	13.9 ( 99999 )	22.0 ( 99999 )	82.1 ( 11 )	119 ( 33 )	( )	( )

Notes
[50] - 0 subjects analyzed
[51] - 0 subjects analyzed

No statistical analyses for this end point

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End point title

BMS-986012 Ctau Accumulation Index (AI_Ctau)

End point description

BMS-986012 Ctau accumulation index (AI_Ctau). Ratio of an exposure measure at steady state to that after the first dose. '99999'=NA

End point type

Secondary

End point timeframe

Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	1	1	2	2	0 ^[52]	0 ^[53]
Units: Ratio
geometric mean (geometric coefficient of variation)	1.81 ( 99999 )	2.31 ( 99999 )	1.76 ( 0 )	1.08 ( 82 )	( )	( )

Notes
[52] - 0 subjects analyzed
[53] - 0 subjects analyzed

No statistical analyses for this end point

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End point title

BMS-986012 Cmax Accumulation Index (AI_Cmax)

End point description

BMS-986012 Cmax accumulation index (AI_Cmax). Ratio of an exposure measure at steady state to that after the first dose. '99999'=NA

End point type

Secondary

End point timeframe

Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	1	1	2	2	0 ^[54]	0 ^[55]
Units: Ratio
geometric mean (geometric coefficient of variation)	0.994 ( 99999 )	1.47 ( 99999 )	1.22 ( 11 )	0.940 ( 70 )	( )	( )

Notes
[54] - 0 subjects analyzed
[55] - 0 subjects analyzed

No statistical analyses for this end point

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End point title

Best Overall Response (BOR)

End point description

BOR defined as the best response designation over the study as a whole. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm

End point type

Secondary

End point timeframe

From first dose to the last tumor assessment prior to subsequent therapy (Up to 97 months)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7	6	29	35	21	8
Units: Participants
Complete Response	1	0	0	0	1	0
Partial Response	0	0	1	1	8	2
Stable Disease	0	2	8	8	2	1
Progressive Disease	4	2	18	21	9	3
Not evaluable	2	2	2	5	1	2

No statistical analyses for this end point

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End point title

BMS-986012 Effective Elimination (T-HALFeff)

End point description

BMS-986012 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure. '99999'=NA

End point type

Secondary

End point timeframe

Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	1	1	2	1	0 ^[56]	0 ^[57]
Units: Hours
arithmetic mean (standard deviation)	342 ( 99999 )	319 ( 999999 )	384 ( 154.2 )	583 ( 99999 )	( )	( )

Notes
[56] - 0 subjects analyzed
[57] - 0 subjects analyzed

No statistical analyses for this end point

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End point title

Duration of Response (DOR) ^[58]

End point description

DOR is defined as the time from first response (CR or PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who remain alive and have not progressed will be censored on the date of their last tumor assessment. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR )= At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm Median DOR will only be evaluated provided there are enough responding participants to warrant inclusion. '99999'=NA

End point type

Secondary

End point timeframe

From the date of first dose to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 97 months)

Notes
[58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: only pre-specified arms planned for this endpoint.

End point values	BMS 400mg + Nivo 360mg
Number of subjects analysed	9
Units: Weeks
median (confidence interval 95%)	114.57 (19.14 to 99999)

No statistical analyses for this end point

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End point title

Objective Response Rate (ORR)

End point description

ORR is defined as the percent of participants whose BOR is either CR or PR. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm

End point type

Secondary

End point timeframe

From first dose date to the date of first documented disease progression (Up to 97 months)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7	6	29	35	21	8
Units: Percent of participants
number (confidence interval 95%)	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	3.4 (0.1 to 17.8)	2.9 (0.1 to 14.9)	42.9 (21.8 to 66.0)	25.0 (3.2 to 65.1)

No statistical analyses for this end point

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End point title

Progression Free Survival (PFS)

End point description

PFS is defined as the time from the date of first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose. Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm

End point type

Secondary

End point timeframe

From first dose to the date of first documented disease progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose (Up to 97 months)

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	7	6	29	35	21	8
Units: Weeks
median (confidence interval 95%)	5.50 (2.43 to 53.00)	5.86 (5.29 to 30.29)	5.79 (5.57 to 8.00)	5.36 (5.00 to 5.71)	17.71 (6.14 to 120.29)	5.71 (2.71 to 25.00)

No statistical analyses for this end point

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End point title

Progression Free Survival Rate (PFSR)

End point description

PFSR is defined as the percent of participants who remain progression free and surviving at "t" weeks (t= 12, 24, 36, 48, 60, 72) Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm 'N'=Number of subjects analyzed '99999'=NA

End point type

Secondary

End point timeframe

Weeks 12, 24, 36, 48, 60, 72

End point values	BMS 70mg	BMS 160mg	BMS 400mg	BMS 1000mg	BMS 400mg + Nivo 360mg	BMS 1000mg + Nivo 360mg
Number of subjects analysed	1 ^[59]	1 ^[60]	6 ^[61]	7 ^[62]	11 ^[63]	2 ^[64]
Units: Percent of participants
number (confidence interval 95%)
Week 12	99999 (99999 to 99999)	99999 (99999 to 99999)	21.4 (8.7 to 37.8)	20.6 (9.1 to 35.3)	55.0 (31.3 to 73.5)	99999 (99999 to 99999)
Week 24	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	45.0 (23.1 to 64.7)	99999 (99999 to 99999)
Week 36	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	45.0 (23.1 to 64.7)	99999 (99999 to 99999)
Week 48	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	35.0 (15.7 to 55.2)	99999 (99999 to 99999)
Week 60	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	35.0 (15.7 to 55.2)	99999 (99999 to 99999)
Week 72	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	35.0 (15.7 to 55.2)	99999 (99999 to 99999)

Notes
[59] - wk12 N=1 wk24 N=1 wk 36 N=1 wk 48 N=1 wk 60 N=0 wk 72 N=0
[60] - wk12 N=1 wk24 N=1 wk 36 N=0 wk 48 N=0 wk 60 N=0 wk 72 N=0
[61] - wk12 N=6 wk24 N=3 wk 36 N=1 wk 48 N=0 wk 60 N=0 wk 72 N=0
[62] - wk12 N=7 wk24 N=3 wk 36 N=2 wk 48 N=1 wk 60 N=1 wk 72 N=1
[63] - wk12 N=11 wk24 N=9 wk 36 N=9 wk 48 N=7 wk 60 N=7 wk 72 N=6
[64] - wk12 N=2 wk24 N=2 wk 36 N=1 wk 48 N=1 wk 60 N=1 wk 72 N=0

No statistical analyses for this end point

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End point title

Number of Participants with Anti-BMS-986012 Antibodies (ADA)

End point description

Number of participants with anti-BMS-986012 antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is a participant with baseline ADA positive sample (Day 1 predose). ADA-positive participant is a participant with at least one ADA positive sample relative to baseline at any time after initiation of treatment during the defined observation time period. ADA negative participant is a participant with no ADA positive sample after the initiation of treatment.

End point type

Secondary

End point timeframe

From first dose to 100 days following the last BMS-986012 dose (Up to 64 months)

No statistical analyses for this end point

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Timeframe for reporting adverse events

SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.1

Reporting group title

BMS 1000mg SCLC Refractory

Reporting group description

1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg SCLC Refractory

Reporting group description

400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 160mg SCLC Refractory

Reporting group description

160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 70mg SCLC Refractory

Reporting group description

70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 1000mg SCLC Sensitive

Reporting group description

1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg SCLC Sensitive

Reporting group description

400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 160mg SCLC Sensitive

Reporting group description

160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 70mg SCLC Sensitive

Reporting group description

70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg SCLC Refractory Espansion

Reporting group description

400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 1000mg SCLC Refractory Expansion

Reporting group description

1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg SCLC Sensitive Expansion

Reporting group description

400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 1000mg SCLC Sensitive Expansion

Reporting group description

1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg + Nivo 360mg SCLC Sensitive

Reporting group description

400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg + Nivo 360mg SCLC Refractory

Reporting group description

400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 1000mg + Nivo 360mg SCLC Sensitive

Reporting group description

1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 1000mg + Nivo 360mg SCLC Refractory

Reporting group description

1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg + Nivo 360mg SCLC Sensitive Expansion

Reporting group description

400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

Reporting group title

BMS 400mg + Nivo 360mg SCLC Refractory Expansion

Reporting group description

400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met

BMS 1000mg SCLC Refractory

BMS 400mg SCLC Refractory

BMS 160mg SCLC Refractory

BMS 70mg SCLC Refractory

BMS 1000mg SCLC Sensitive

BMS 400mg SCLC Sensitive

BMS 160mg SCLC Sensitive

BMS 70mg SCLC Sensitive

BMS 400mg SCLC Refractory Espansion

BMS 1000mg SCLC Refractory Expansion

BMS 400mg SCLC Sensitive Expansion

BMS 1000mg SCLC Sensitive Expansion

BMS 400mg + Nivo 360mg SCLC Sensitive

BMS 400mg + Nivo 360mg SCLC Refractory

BMS 1000mg + Nivo 360mg SCLC Sensitive

BMS 1000mg + Nivo 360mg SCLC Refractory

BMS 400mg + Nivo 360mg SCLC Sensitive Expansion

BMS 400mg + Nivo 360mg SCLC Refractory Expansion

Total subjects affected by serious adverse events

subjects affected / exposed

3 / 3 (100.00%)

2 / 2 (100.00%)

3 / 3 (100.00%)

2 / 6 (33.33%)

4 / 4 (100.00%)

2 / 4 (50.00%)

4 / 4 (100.00%)

8 / 12 (66.67%)

6 / 10 (60.00%)

11 / 14 (78.57%)

4 / 6 (66.67%)

1 / 2 (50.00%)

2 / 5 (40.00%)

3 / 3 (100.00%)

4 / 9 (44.44%)

2 / 4 (50.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

Malignant neoplasm progression

subjects affected / exposed

3 / 3 (100.00%)

2 / 3 (66.67%)

1 / 2 (50.00%)

1 / 3 (33.33%)

1 / 6 (16.67%)

1 / 4 (25.00%)

2 / 4 (50.00%)

3 / 4 (75.00%)

5 / 12 (41.67%)

6 / 12 (50.00%)

3 / 10 (30.00%)

6 / 14 (42.86%)

3 / 6 (50.00%)

0 / 2 (0.00%)

2 / 5 (40.00%)

2 / 3 (66.67%)

1 / 9 (11.11%)

1 / 4 (25.00%)

occurrences causally related to treatment / all

0 / 3

0 / 2

0 / 1

0 / 2

0 / 3

0 / 5

0 / 6

0 / 3

0 / 6

0 / 4

0 / 0

0 / 2

0 / 1

0 / 2

deaths causally related to treatment / all

0 / 3

0 / 2

0 / 1

0 / 2

0 / 4

0 / 6

0 / 3

0 / 5

0 / 3

0 / 0

0 / 2

0 / 1

Metastases to central nervous system

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 10 (10.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tumour pain

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Hypotension

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Superior vena cava occlusion

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Oedema peripheral

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

1 / 3 (33.33%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fatigue

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

2 / 4 (50.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Performance status decreased

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

1 / 6 (16.67%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain

subjects affected / exposed

1 / 3 (33.33%)

1 / 2 (50.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Pyrexia

subjects affected / exposed

0 / 3 (0.00%)

1 / 3 (33.33%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Bronchial artery hypertrophy

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Chronic obstructive pulmonary disease

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Dyspnoea

subjects affected / exposed

1 / 3 (33.33%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

1 / 10 (10.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Haemoptysis

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

2 / 14 (14.29%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoxia

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pleural effusion

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

2 / 12 (16.67%)

0 / 12 (0.00%)

1 / 10 (10.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory failure

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

1 / 3 (33.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Psychiatric disorders

Confusional state

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Delirium

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mental status changes

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric decompensation

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Fall

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

1 / 6 (16.67%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infusion related reaction

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lumbar vertebral fracture

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

1 / 6 (16.67%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Radiation necrosis

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 10 (10.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Toxicity to various agents

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal fracture

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Atrial fibrillation

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 12 (0.00%)

1 / 10 (10.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac tamponade

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pericardial effusion

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

1 / 2 (50.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Cerebrovascular accident

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

1 / 3 (33.33%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 10 (10.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Encephalopathy

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dysarthria

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Transient ischaemic attack

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Anaemia

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Febrile neutropenia

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Thrombocytopenia

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal pain

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abdominal pain upper

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colitis

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

1 / 6 (16.67%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastric haemorrhage

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

1 / 3 (33.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intestinal obstruction

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancreatitis

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

1 / 6 (16.67%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Retroperitoneal haemorrhage

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Small intestinal obstruction

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Hepatic failure

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

1 / 3 (33.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Acute hepatic failure

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Pruritus

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Haematuria

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Endocrine disorders

Adrenal insufficiency

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

1 / 4 (25.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Hyperthyroidism

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Pathological fracture

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 10 (10.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Bacterial infection

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea infectious

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

1 / 2 (50.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Enterocolitis infectious

subjects affected / exposed

0 / 3 (0.00%)

1 / 2 (50.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Influenza

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

1 / 3 (33.33%)

0 / 6 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 12 (0.00%)

1 / 10 (10.00%)

1 / 14 (7.14%)

1 / 6 (16.67%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Lower respiratory tract infection

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 10 (10.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sepsis

subjects affected / exposed

0 / 3 (0.00%)

1 / 3 (33.33%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 10 (10.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Upper respiratory tract infection

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Hyponatraemia

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 10 (0.00%)

1 / 14 (7.14%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

1 / 4 (25.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Hypophosphataemia

subjects affected / exposed

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 10 (0.00%)

0 / 14 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	BMS 1000mg SCLC Refractory	BMS 400mg SCLC Refractory	BMS 160mg SCLC Refractory	BMS 70mg SCLC Refractory	BMS 1000mg SCLC Sensitive	BMS 400mg SCLC Sensitive	BMS 160mg SCLC Sensitive	BMS 70mg SCLC Sensitive	BMS 400mg SCLC Refractory Espansion	BMS 1000mg SCLC Refractory Expansion	BMS 400mg SCLC Sensitive Expansion	BMS 1000mg SCLC Sensitive Expansion	BMS 400mg + Nivo 360mg SCLC Sensitive	BMS 400mg + Nivo 360mg SCLC Refractory	BMS 1000mg + Nivo 360mg SCLC Sensitive	BMS 1000mg + Nivo 360mg SCLC Refractory	BMS 400mg + Nivo 360mg SCLC Sensitive Expansion	BMS 400mg + Nivo 360mg SCLC Refractory Expansion
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 3 (100.00%)	3 / 3 (100.00%)	2 / 2 (100.00%)	3 / 3 (100.00%)	6 / 6 (100.00%)	4 / 4 (100.00%)	4 / 4 (100.00%)	4 / 4 (100.00%)	12 / 12 (100.00%)	12 / 12 (100.00%)	10 / 10 (100.00%)	14 / 14 (100.00%)	6 / 6 (100.00%)	2 / 2 (100.00%)	5 / 5 (100.00%)	3 / 3 (100.00%)	9 / 9 (100.00%)	4 / 4 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Tumour pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0
Vascular disorders
Embolism
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Deep vein thrombosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Flushing
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0	1	0	0	0	0	0	1
Hot flush
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Hypotension
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Hypertension
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	3 / 10 (30.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	2	3	0	0	0	0	0	1	0
Poor venous access
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Catheter site pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Asthenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0
Axillary pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0
Chest discomfort
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 10 (20.00%)	3 / 14 (21.43%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	3	3	1	0	0	0	0	0
Chest pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	1	0	0	0	0	2	0
Feeling cold
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Face oedema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Fatigue
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 3 (66.67%)	3 / 6 (50.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	3 / 4 (75.00%)	4 / 12 (33.33%)	7 / 12 (58.33%)	3 / 10 (30.00%)	12 / 14 (85.71%)	2 / 6 (33.33%)	1 / 2 (50.00%)	2 / 5 (40.00%)	2 / 3 (66.67%)	4 / 9 (44.44%)	4 / 4 (100.00%)
occurrences all number	0	0	0	2	3	1	1	4	4	8	3	13	2	1	2	2	4	6
Chills
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	0	1	0
Gait disturbance
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	1	1	1	0	0	0	1	0	1	0	0	0	0	0	1
Generalised oedema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Infusion site pruritus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Infusion site erythema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Influenza like illness
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0
Infusion site swelling
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Malaise
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	3 / 9 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	3	0
Non-cardiac chest pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	2 / 14 (14.29%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	1	0	2	1	0	0	0	1	0
Mucosal inflammation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0
Nodule
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Mucosal dryness
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Oedema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	4 / 12 (33.33%)	2 / 10 (20.00%)	2 / 14 (14.29%)	2 / 6 (33.33%)	1 / 2 (50.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	1	2	0	0	0	0	0	1	1	4	3	2	2	1	1	0	2	0
Pyrexia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	0	0	1	1	0	0	2	0	1	0
Peripheral swelling
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 10 (10.00%)	2 / 14 (14.29%)	1 / 6 (16.67%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	1	2	2	0	1	0	1	0
Swelling face
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Thirst
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Immune system disorders
Dust allergy
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Contrast media reaction
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Seasonal allergy
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Reproductive system and breast disorders
Genital burning sensation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Acquired phimosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Pelvic pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0
Penile erythema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Pruritus genital
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	2 / 14 (14.29%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	2	0	0	0	0	0	0
Vulvovaginal burning sensation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Vulvovaginal pruritus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	1 / 3 (33.33%)	2 / 6 (33.33%)	0 / 4 (0.00%)	1 / 4 (25.00%)	2 / 4 (50.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	3	2	0	1	2	0	0	1	0	2	0	2	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	2 / 3 (66.67%)	2 / 6 (33.33%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 10 (10.00%)	3 / 14 (21.43%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	4 / 9 (44.44%)	1 / 4 (25.00%)
occurrences all number	0	1	0	3	2	1	2	0	1	0	1	3	0	1	0	0	4	1
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0
Bronchospasm
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Epistaxis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	2	0	0	0	0	0	0	0	0	0	0
Dyspnoea exertional
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	2 / 14 (14.29%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	2	2	0	0	0	0	0
Dyspnoea
subjects affected / exposed	2 / 3 (66.67%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	2 / 12 (16.67%)	2 / 12 (16.67%)	1 / 10 (10.00%)	2 / 14 (14.29%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	1 / 3 (33.33%)	3 / 9 (33.33%)	0 / 4 (0.00%)
occurrences all number	2	1	0	0	1	0	1	1	2	2	1	2	0	0	1	1	3	0
Haemoptysis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	2 / 4 (50.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	1	0	0	0	0	0	0	2
Dysphonia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1
Nasal congestion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	1
Nasal dryness
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Hiccups
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Laryngeal haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Pneumonitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0
Pleuritic pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Pleural effusion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	2	0	0	0	1	0	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0
Productive cough
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 10 (0.00%)	3 / 14 (21.43%)	2 / 6 (33.33%)	0 / 2 (0.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	4	3	0	2	0	4	0
Pulmonary haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Rales
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Rhinitis allergic
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	1	0
Rhinorrhoea
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Sneezing
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Upper-airway cough syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Wheezing
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 10 (20.00%)	3 / 14 (21.43%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	2	3	0	1	0	0	0	0
Psychiatric disorders
Abnormal dreams
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Agitation
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 10 (10.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	1	1	1	0	0	0	0	0	0
Depression
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	1	1	0	0	0
Anxiety
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	2 / 4 (50.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	1	2	0	0	1	0	0	1	1	1	0	0
Confusional state
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	3 / 12 (25.00%)	0 / 10 (0.00%)	2 / 14 (14.29%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	4	0	2	0	1	1	0	0	1
Delirium
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Mood altered
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Disorientation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Hallucination
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Insomnia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	3 / 10 (30.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	3 / 9 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	2	0	1	0	0	1	3	1	0	0	0	1	3	0
Restlessness
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	1	0
Amylase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	2
Bacterial test positive
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Aspartate aminotransferase increased
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	2	0
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0
Body temperature fluctuation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Blood creatinine increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	1 / 6 (16.67%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0	1	1	1	0	0	1	2
Blood bilirubin increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Electrocardiogram QT prolonged
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Clostridium test positive
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Body temperature increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
General physical condition abnormal
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
International normalised ratio increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Lipase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1
Platelet count decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Staphylococcus test positive
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0
Streptococcus test positive
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Vitamin D decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Weight decreased
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	3 / 12 (25.00%)	1 / 10 (10.00%)	2 / 14 (14.29%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	1	0	0	1	0	0	0	1	3	1	2	0	0	0	1	1	1
White blood cell count decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Weight increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Bone contusion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Contusion
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	1	0	1	0	0	0	0	0
Fall
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	1	0	0	0	0	0	0	0
Infusion related reaction
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	2 / 14 (14.29%)	2 / 6 (33.33%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	1	0	2	2	0	0	1	1	0
Post procedural urine leak
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Procedural pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin abrasion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0	0	0	1	0	0	0
Scratch
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 10 (20.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0
Wound
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Cardiac disorders
Atrial flutter
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Atrial fibrillation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 10 (10.00%)	2 / 14 (14.29%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	1	1	2	0	0	0	0	0	0
Atrioventricular block second degree
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Sinus tachycardia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	3	0	0	0	0
Palpitations
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Tachycardia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0
Ventricular tachycardia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Nervous system disorders
Ataxia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Burning sensation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Balance disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1
Cerebral ischaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Dementia Alzheimer's type
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Cerebrovascular accident
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Cognitive disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Depressed level of consciousness
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Disturbance in attention
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0
Dizziness
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 3 (66.67%)	1 / 6 (16.67%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 10 (20.00%)	1 / 14 (7.14%)	2 / 6 (33.33%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	2	1	0	1	1	0	0	2	1	2	0	1	0	2	1
Dysaesthesia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypersomnia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Hemiparesis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Headache
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	2 / 4 (50.00%)	1 / 4 (25.00%)	2 / 4 (50.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	1 / 10 (10.00%)	1 / 14 (7.14%)	2 / 6 (33.33%)	2 / 2 (100.00%)	2 / 5 (40.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	1	0	0	0	0	2	1	2	0	3	1	1	3	2	2	1	0	2
Dysarthria
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dysgeusia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1	1	0	0	2	0	0	0	0	0	0	0	2	1
Dysmetria
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Myoclonus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0
Neuropathy peripheral
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	1	0	0	1	0	0	0	0	2	0
Neuralgia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0
Memory impairment
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	1	0	0	0	1	0	1	0	0	0	0	0	0	0	1	1	1
Hypoaesthesia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	1	0
Peroneal nerve palsy
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Parosmia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Paraesthesia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 3 (0.00%)	2 / 6 (33.33%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	1 / 4 (25.00%)
occurrences all number	0	0	1	0	2	0	0	0	0	2	0	1	0	1	4	0	2	1
Peripheral sensory neuropathy
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	2 / 10 (20.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	1	2	0	0	0	0	0	3	0
Presyncope
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Somnolence
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0
Restless legs syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0
Transient ischaemic attack
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Syncope
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	2	0	0	0	0	0
Tremor
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0	1	0	0	0	0	0	0
Blood and lymphatic system disorders
Febrile neutropenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1
Anaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	1 / 10 (10.00%)	1 / 14 (7.14%)	1 / 6 (16.67%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	1	0	1	2	2	1	1	1	2	0	0	1	2
Myelosuppression
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Neutropenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	3	1
Thrombocytopenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	1
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Deafness
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypoacusis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0
Middle ear effusion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Vertigo
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0
Eye disorders
Conjunctival haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Cataract
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Eye irritation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Eye inflammation
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Eye discharge
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Dry eye
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	1	0	2	0	0	1
Diplopia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Eye pruritus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	2 / 6 (33.33%)	1 / 4 (25.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 10 (10.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	2	2	2	1	1	1	1	1	0	0	1	0	1	0
Eyelid disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Eyelid pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Myopia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Eyelids pruritus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Ophthalmic vein thrombosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Ocular hyperaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Photophobia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Retinal artery occlusion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Swelling of eyelid
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0
Vision blurred
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	1 / 5 (20.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0	1	0	1	1	0	0
Vitreous floaters
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Visual impairment
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0
Abdominal pain lower
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	1	0	0	0	0	1	0	0	0
Abdominal pain
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	2 / 12 (16.67%)	3 / 12 (25.00%)	3 / 10 (30.00%)	3 / 14 (21.43%)	1 / 6 (16.67%)	1 / 2 (50.00%)	1 / 5 (20.00%)	1 / 3 (33.33%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	2	0	0	0	0	1	0	1	2	3	3	3	3	1	1	1	6	0
Abdominal distension
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	1	2	2	0	0
Abdominal pain upper
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	3 / 9 (33.33%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	3	0
Aphthous ulcer
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Diarrhoea
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 2 (50.00%)	0 / 3 (0.00%)	2 / 6 (33.33%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	5 / 12 (41.67%)	2 / 10 (20.00%)	3 / 14 (21.43%)	1 / 6 (16.67%)	1 / 2 (50.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	4 / 9 (44.44%)	1 / 4 (25.00%)
occurrences all number	0	1	1	0	2	0	1	1	0	6	2	3	5	1	7	0	15	1
Defaecation urgency
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Constipation
subjects affected / exposed	2 / 3 (66.67%)	1 / 3 (33.33%)	1 / 2 (50.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	1 / 4 (25.00%)	1 / 4 (25.00%)	3 / 4 (75.00%)	5 / 12 (41.67%)	2 / 12 (16.67%)	6 / 10 (60.00%)	3 / 14 (21.43%)	2 / 6 (33.33%)	0 / 2 (0.00%)	1 / 5 (20.00%)	2 / 3 (66.67%)	4 / 9 (44.44%)	1 / 4 (25.00%)
occurrences all number	4	1	1	1	1	1	1	3	6	2	6	3	3	0	4	3	5	1
Diarrhoea haemorrhagic
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Dry mouth
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 10 (10.00%)	2 / 14 (14.29%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	1 / 3 (33.33%)	2 / 9 (22.22%)	1 / 4 (25.00%)
occurrences all number	0	0	0	2	1	0	0	0	1	0	2	2	0	0	4	1	3	2
Dyspepsia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	2 / 9 (22.22%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	1	4	1
Dysphagia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Epigastric discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Flatulence
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0
Gingival pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Mouth ulceration
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Impaired gastric emptying
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Lip blister
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Haemorrhoids
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Nausea
subjects affected / exposed	2 / 3 (66.67%)	2 / 3 (66.67%)	1 / 2 (50.00%)	1 / 3 (33.33%)	2 / 6 (33.33%)	1 / 4 (25.00%)	1 / 4 (25.00%)	4 / 4 (100.00%)	2 / 12 (16.67%)	7 / 12 (58.33%)	3 / 10 (30.00%)	5 / 14 (35.71%)	2 / 6 (33.33%)	1 / 2 (50.00%)	3 / 5 (60.00%)	1 / 3 (33.33%)	4 / 9 (44.44%)	2 / 4 (50.00%)
occurrences all number	2	2	2	1	5	1	1	4	2	9	3	8	3	2	6	1	6	5
Odynophagia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Stomatitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	2 / 14 (14.29%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	2	0	1	0	0	1	0	2	0	0	0	0	1	0
Proctitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Oral discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Swollen tongue
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Toothache
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Vomiting
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 3 (0.00%)	3 / 6 (50.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	3 / 10 (30.00%)	2 / 14 (14.29%)	2 / 6 (33.33%)	1 / 2 (50.00%)	1 / 5 (20.00%)	1 / 3 (33.33%)	4 / 9 (44.44%)	1 / 4 (25.00%)
occurrences all number	1	0	2	0	7	1	3	2	1	2	3	2	3	3	3	2	4	2
Hepatobiliary disorders
Hyperbilirubinaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Biliary colic
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 10 (10.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	3 / 9 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	1	1	0	1	0	0	0	6	0
Dermal cyst
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Dermatitis acneiform
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0	0	1	0	0	0	0
Dry skin
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 4 (50.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 10 (0.00%)	1 / 14 (7.14%)	1 / 6 (16.67%)	0 / 2 (0.00%)	3 / 5 (60.00%)	1 / 3 (33.33%)	3 / 9 (33.33%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1	0	0	2	0	2	0	1	1	0	3	1	3	2
Hyperhidrosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	3 / 12 (25.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	1	0	0
Hand dermatitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Erythema multiforme
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Erythema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0	0	0	0	1	0	2	0
Eczema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	1
Miliaria
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Nail disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Nail hypertrophy
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Night sweats
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0
Onychoclasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	2	0	0	0	0	0
Onychomadesis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Pain of skin
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0
Palmar erythema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Pemphigoid
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Petechiae
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1
Photosensitivity reaction
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Rash erythematous
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Rash
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 10 (20.00%)	2 / 14 (14.29%)	2 / 6 (33.33%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	1	0	2	2	2	0	0	0	0	0
Purpura
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Psoriasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0
Pruritus
subjects affected / exposed	3 / 3 (100.00%)	3 / 3 (100.00%)	2 / 2 (100.00%)	2 / 3 (66.67%)	6 / 6 (100.00%)	4 / 4 (100.00%)	2 / 4 (50.00%)	4 / 4 (100.00%)	12 / 12 (100.00%)	9 / 12 (75.00%)	8 / 10 (80.00%)	13 / 14 (92.86%)	5 / 6 (83.33%)	1 / 2 (50.00%)	5 / 5 (100.00%)	3 / 3 (100.00%)	9 / 9 (100.00%)	4 / 4 (100.00%)
occurrences all number	4	4	2	2	8	4	3	4	15	10	9	15	5	1	7	3	15	4
Rash papular
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Rash maculo-papular
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	3 / 12 (25.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	3	1	0	0	0	2	0	0	1
Rash macular
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	1	0	0	0	0	0	0
Rash pruritic
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Rash vesicular
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	2 / 14 (14.29%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	0	0	2	0	0	0
Skin disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Skin discolouration
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Scab
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Skin exfoliation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Skin ulcer
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Skin mass
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Skin lesion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	1	0	1	0	0	1
Urticaria
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Acute kidney injury
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1
Haematuria
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0
Hydronephrosis
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Leukocyturia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Nocturia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1
Renal failure
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Renal disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Proteinuria
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	4	0
Pollakiuria
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0
Urinary tract pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Urinary incontinence
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	3 / 9 (33.33%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	1	0	1	0	3	1
Hyperthyroidism
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	2
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 3 (66.67%)	0 / 6 (0.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	3 / 12 (25.00%)	2 / 12 (16.67%)	1 / 10 (10.00%)	1 / 14 (7.14%)	2 / 6 (33.33%)	1 / 2 (50.00%)	3 / 5 (60.00%)	1 / 3 (33.33%)	9 / 9 (100.00%)	2 / 4 (50.00%)
occurrences all number	0	0	0	2	0	1	1	1	3	2	1	1	2	1	3	1	13	2
Back pain
subjects affected / exposed	0 / 3 (0.00%)	2 / 3 (66.67%)	1 / 2 (50.00%)	1 / 3 (33.33%)	2 / 6 (33.33%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	4 / 12 (33.33%)	4 / 10 (40.00%)	2 / 14 (14.29%)	3 / 6 (50.00%)	2 / 2 (100.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	3 / 9 (33.33%)	1 / 4 (25.00%)
occurrences all number	0	2	1	3	2	0	1	0	1	4	4	2	4	2	2	0	5	2
Arthritis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0
Bone pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Bursitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Flank pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	1	0	0	0
Joint swelling
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0
Groin pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	1	0
Muscle twitching
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	1	0
Muscle spasms
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	2	0	0	2	0	2	1	0	0	0	0	0	0	0
Muscular weakness
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	1 / 10 (10.00%)	2 / 14 (14.29%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	2	1	2	0	0	0	1	1	0
Musculoskeletal disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 10 (10.00%)	1 / 14 (7.14%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	1	1	1	1	1	0	0	0	2	0
Musculoskeletal pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Myalgia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	1 / 5 (20.00%)	1 / 3 (33.33%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	3	0	0	2	0	3	1	2	0
Neck pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 3 (66.67%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	2	1	0	0	1	0	1	0	0	0	1	3	0	1	0
Osteoarthritis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Pain in extremity
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	3 / 12 (25.00%)	2 / 10 (20.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	1 / 4 (25.00%)
occurrences all number	0	0	0	1	1	1	1	0	1	3	2	1	0	0	4	0	5	1
Pain in jaw
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	2	0	0	0
Pathological fracture
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Polymyalgia rheumatica
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2
Synovial cyst
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Tendon pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0
Conjunctivitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 10 (10.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0
Cellulitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Candida infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Cystitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	2	0
Diverticulitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Gastroenteritis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1
Escherichia pyelonephritis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Folliculitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Ear infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Herpes virus infection
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hordeolum
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1
Localised infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0
Lower respiratory tract infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 10 (10.00%)	1 / 14 (7.14%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	1	1	1	0	0	0	0	0
Nail bed infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Pneumonia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Oral candidiasis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	1	2	0	0	1	0	1	0	0	0
Oral herpes
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	1	1	0	0	1	1	3	0	0	0	0	0	0	2	1
Nasopharyngitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	4 / 9 (44.44%)	2 / 4 (50.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	5	3
Pneumonia aspiration
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Pneumonia haemophilus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Skin infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Respiratory tract infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0
Sinusitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	1	1	0	1	0
Pustule
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Soft tissue infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Tooth abscess
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	3 / 9 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	1	0	0	1	0	4	0	0	9	0
Upper respiratory tract infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	2 / 14 (14.29%)	1 / 6 (16.67%)	1 / 2 (50.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	4	1	1	0	0	5	0
Tracheitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	1 / 2 (50.00%)	2 / 3 (66.67%)	2 / 6 (33.33%)	2 / 4 (50.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	6 / 12 (50.00%)	5 / 12 (41.67%)	7 / 10 (70.00%)	6 / 14 (42.86%)	2 / 6 (33.33%)	0 / 2 (0.00%)	1 / 5 (20.00%)	2 / 3 (66.67%)	1 / 9 (11.11%)	2 / 4 (50.00%)
occurrences all number	1	1	1	2	2	2	1	1	6	6	7	7	2	0	1	2	2	4
Dehydration
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 10 (0.00%)	1 / 14 (7.14%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	3	1	0	1	1	0	0	1	0	0
Fluid retention
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	0
Glucose tolerance impaired
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Hypercalcaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	3 / 12 (25.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	1	0	0	0	0	0	0
Hyperglycaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0	1	0	0	0	0	2	1
Hyperkalaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	1
Hypernatraemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypertriglyceridaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Hypoalbuminaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Hypocalcaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0
Hypokalaemia
subjects affected / exposed	0 / 3 (0.00%)	2 / 3 (66.67%)	1 / 2 (50.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)
occurrences all number	0	3	1	1	0	3	0	1	1	2	0	0	1	0	2	0	5	0
Hypomagnesaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	3 / 4 (75.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 12 (16.67%)	4 / 12 (33.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	1 / 5 (20.00%)	0 / 3 (0.00%)	3 / 9 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	3	0	0	2	5	0	0	0	1	1	0	10	0
Hypophosphataemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0
Hypophagia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Hyponatraemia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 10 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	1 / 2 (50.00%)	2 / 5 (40.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)
occurrences all number	1	0	0	0	0	1	0	0	1	2	0	0	1	3	5	0	2	4
Type 2 diabetes mellitus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 10 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 5 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0

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Were there any global substantial amendments to the protocol? Yes

17 Mar 2015

Schedule of activities updated.

18 Dec 2015

Eligibility criteria and exploratory objectives updated.

06 Jun 2016

Study design and drug update

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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Austria
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End point values

BMS 1000mg

BMS 400mg + Nivo 360mg

BMS 1000mg + Nivo 360mg

Number of subjects analysed

Units: Participants

Baseline ADA positive

ADA positive

ADA negative