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Clinical Trial Results:
An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination in patients with advanced solid/metastatic tumours

Summary
EudraCT number	2018-000285-10
Trial protocol	FR ES
Global end of trial date	06 Jul 2025

Results information
Results version number	v1(current)
This version publication date	22 Jul 2026
First version publication date	22 Jul 2026
Other versions

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

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Trial information

Top of page

Sponsor protocol code

CCS1477-01

ISRCTN number

US NCT number

NCT03568656

WHO universal trial number (UTN)

Sponsor organisation name

CellCentric Ltd

Sponsor organisation address

Chesterford Research Park, Little Chesterford, Cambridge, United Kingdom, CB10 1XL

Public contact

Study Director , CellCentric Ltd, +44 1799531130, clinical@cellcentric.com

Scientific contact

Study Director , CellCentric Ltd, +44 1799531130, clinical@cellcentric.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

06 Jul 2025

Is this the analysis of the primary completion data?

Yes

Primary completion date

06 Jul 2025

Global end of trial reached?

Yes

Global end of trial date

06 Jul 2025

Was the trial ended prematurely?

Main objective of the trial

To investigate the safety and tolerability of CCS1477 as monotherapy and in combination.

Protection of trial subjects

During the conduct of the study all participants were closely monitored.

Background therapy

Evidence for comparator

Actual start date of recruitment

23 Jul 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 190

Country: Number of subjects enrolled

France: 12

Country: Number of subjects enrolled

Spain: 5

Country: Number of subjects enrolled

Netherlands: 2

Country: Number of subjects enrolled

Sweden: 5

Country: Number of subjects enrolled

United States: 5

Worldwide total number of subjects

219

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

165

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

A total of 310 subjects were screened for this study. Of these, 235 subjects were assigned to a treatment group of which 219 received at least 1 dose of CCS1477 at any dose as either monotherapy or in combination with another product.

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part A: CCS1477 100mg Once Daily

Arm description

Participants with metastatic castration resistant prostate cancer (mCRPC) received 100 mg (milligrams) of CCS1477 once daily (OD) orally until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 100 mg once daily until disease progression.

Part A: CCS1477 100mg, 2/Week

Arm description

Participants with mCRPC received 100 mg of CCS1477 twice per week (2/week) orally until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 100 mg CCS1477 twice per week (2/week).

Part A: CCS1477 100mg, 3 Days on and 4 Days Off

Arm description

Participants with mCRPC received 100 mg of CCS1477 orally for 3 consecutive days, followed by 4 days (D) off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 100 mg CCS1477 for 3 consecutive days, followed by 4 days off, and continued on this schedule until disease progression.

Part A: CCS1477 100mg, 3/Week

Arm description

Participants with mCRPC received 100 mg of CCS1477 thrice per week (3/week) orally until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 100 mg CCS1477 thrice per week (3/week) until disease progression.

Part A: CCS1477 50mg BD, 3 Days on and 4 Days Off

Arm description

Participants with mCRPC received 50 mg of CCS1477 BD orally for 3 consecutive days, followed by 4Ds off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 50mg CCS1477 twice daily (BD) for 3 consecutive days, followed by 4 days off, and continued on this schedule until disease progression.

Part A: CCS1477 50mg Once Daily

Arm description

Participants with mCRPC received 50 mg of CCS1477 OD orally until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 50mg once daily until disease progression.

Part A: CCS1477 25mg BD, Daily

Arm description

Participants with mCRPC received 25 mg of CCS1477 BD orally until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 25mg twice daily (BD) until disease progression.

Part A: CCS1477 25mg Once Daily

Arm description

Participants with mCRPC received 25 mg of CCS1477 OD orally until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 25mg once daily until disease progression.

Part A: CCS1477 50mg, 4 Days on and 3 Days Off

Arm description

Participants with mCRPC received 50 mg of CCS1477 OD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 50mg once daily for 4 consecutive days, followed by 3days off, and continued on this schedule until disease progression.

Part A: CCS1477 50mg, 5 Days on and 2 Days Off

Arm description

Participants with mCRPC received 50 mg of CCS1477 OD orally for 5 consecutive days, followed by 2D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 50mg once daily for 5 consecutive days, followed by 2days off, and continued on this schedule until disease progression.

Part A: CCS1477(10mg-MF/20mg-MF) 50mg, 4 D On and 3 D Off

Arm description

Participants with mCRPC received 50 mg (10mg-Modified formulation (MF)/20mg-MF) of CCS1477 OD orally for 4 consecutive days, followed by 3) off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 50 mg (10mg-Modified formulation/20mg-Modified formulation) of CCS1477 once daily for 4 consecutive days, followed by 3 days off, and continued on this schedule until disease progression.

Part A: CCS147750 mg-MF, 4D on and 3D Off

Arm description

Participants with mCRPC received 50 mg -MF of CCS1477 OD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 50 mg-MF once daily for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression.

Part A: CCS1477 30mg-MF,4 Days on and 3D Off

Arm description

Participants with mCRPC received 30 mg -MF of CCS1477 OD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 30 mg - MF once daily for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression.

Part A: CCS1477 75mg-MF, 4Days on and 3Days Off

Arm description

Participants with mCRPC received 75 mg -MF of CCS1477 OD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 75 mg -Modified Formulation once daily for 4 consecutive days, followed by 3 days off, and continued on this schedule until disease progression.

PartA: CCS1477 50mg BD-MF, 4D on and 3D Off

Arm description

Participants with mCRPC received 50 mg -MF of CCS1477 BD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 50 mg -Modified Formulation twice daily (BD) for 4 consecutive days, followed by 3 days off, and continued on this schedule until disease progression.

PartA: CCS1477 35mg BD-MF, 10 D on and 4 D Off

Arm description

Participants with mCRPC received 35 mg -MF of CCS1477 BD orally for 10 consecutive days, followed by 4D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 35 mg - Modified Formulation twice daily (BD) for 10 consecutive days, followed by 4 days off, and continued on this schedule until disease progression.

Part A: CCS1477 50mg OD-MF, 10D on and 4D Off

Arm description

Participants with mCRPC received 50 mg -MF of CCS1477 OD orally for 10 consecutive days, followed by 4D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 50 mg -Modified Formulation once daily (OD) for 10 consecutive days, followed by 4 days off, and continued on this schedule until disease progression.

Part A and B1:CCS1477 35mg BD-MF, 4D on and 3D Off

Arm description

Participants with mCRPC received recommended Phase II dose of 35mg - MF of CCS1477 BD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study intervention.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 35 mg CCS1477 - MF BD for 4 consecutive days, followed by 3 days off, and continued on this schedule until disease progression.

Part C1: CCS1477 50mg - MF + Abiraterone, 4D on and 3D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 50mg MF, administered orally OD for 4 consecutive days followed by 3D off. In addition, participants received abiraterone 1000 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received CCS1477 50 mg- MF administered once daily for 4 consecutive days followed by 3 days off.

Investigational medicinal product name

Abiraterone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Patients received abiraterone 1000 mg once daily on a continuous schedule along with CCS1477, 50mg MF.

Part C1: CCS1477 35mg-MF BD + Abiraterone, 4D on and 3D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 35mg MF, administered orally BD for 4 consecutive days followed by 3D off. In addition, participants received abiraterone 1000 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 35mg CCS1477 MF, administered twice daily (BD) for 4 consecutive days followed by 3D off.

Investigational medicinal product name

Abiraterone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

In addition, participants received abiraterone 1000 mg once daily on a continuous schedule along with CCS1477, 35mg MF.

Part D1: CCS1477 50mg-MF + Enzalutamide, 4D on and 3D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 50mg MF, administered orally OD for 4 consecutive days followed by 3D off. In addition, participants received enzalutamide 160 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

Enzalutamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

In addition, participants received enzalutamide 160 mg once daily on a continuous schedule along with CCS1477, 50mg MF.

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

In addition, participants received 50mg CCS1477 MF, administered once daily for 4consecutive days followed by 3D off.

Part D1: CCS14777 75mg-MF + Enzalutamide, 4D on and 3D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 75mg MF, administered orally OD for 4 consecutive days followed by 3D off. In addition, participants received enzalutamide 160 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

In addition, participants received 75mg CCS1477 MF, administered once daily for 4 consecutive days followed by 3D off.

Investigational medicinal product name

Enzalutamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received enzalutamide 160 mg orally OD on a continuous schedule along with 50mg CCS1477 MF.

Part D1: CCS1477 100mg-MF + Enzalutamide, 4 D on and 3D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 100mg MF, administered orally OD for 4 consecutive days followed by 3D off. In addition, participants received enzalutamide160 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received 100mg CCS1477 MF, administered once daily for 4 consecutive days followed by 3D off.

Investigational medicinal product name

Enzalutamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received enzalutamide 160 mg orally once daily on a continuous schedule along with 100 mg CCS1477 MF.

Part D1: CCS1477 75mg-MF + Enzalutamide Daily

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 75mg MF, administered orally OD. In addition, participants received enzalutamide 160 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

Enzalutamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received enzalutamide 160 mg once daily on a continuous schedule along with 75mg CCS1477 MF.

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 75mg CCS1477 MF, administered once daily.

Part D1: CCS1477 75mg BD - MF + Enzalutamide, 4D on 3 D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 75mg MF, administered orally BD for 4 consecutive days followed by 3D off. In addition, participants received enzalutamide160 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 75mg CCS1477 MF, administered twice daily for 4 consecutive days followed by 3D off.

Investigational medicinal product name

Enzalutamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received enzalutamide 160 mg OD on a continuous schedule along with 75mg CCS1477 MF.

Part D1:CCS1477 35mg and 75mg BD-MF+Enzalutamide, 4D on/3D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 35mg and 75 mg MF, administered orally BD for 4 consecutive days followed by 3D off. In addition, participants received enzalutamide 160 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 35mg and 75mg CCS1477 MF, administered orally twice daily for 4 consecutive days followed by 3D off.

Investigational medicinal product name

Enzalutamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received enzalutamide 160 mg once daily on a continuous schedule along with CCS1477, 35mg and 75mg CCS1477 MF.

Part D1:CCS1477 50mg Daily-MF+Enzalutamide, 10 D on and 4D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 50mg MF, administered orally OD for 10 consecutive days followed by 4D off. In addition, participants received Enzalutamide 160 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 50mg CCS1477 MF, administered once daily for 10 consecutive days followed by 4D off.

Investigational medicinal product name

Enzalutamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received enzalutamide 160 mg once daily on a continuous schedule along with CCS1477, 50mg CCS1477 MF.

Part E1: CCS1477 50mg Daily, 4D on and 3D Off

Arm description

Participants with advanced solid tumours with molecular markers which may indicate potential for response to p300/CBP inhibition received 50mg of CCS1477 OD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 50 mg CCS1477 OD for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression.

Part E1: CCS1477 50mg-MF, 4D on and 3D Off

Arm description

Participants with advanced solid tumours with molecular markers which may indicate potential for response to p300/CBP inhibition received 50mg MF of CCS1477 OD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 50mg CCS1477 MF OD for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression.

Part E1: CCS1477 75mg-MF, 4D on and 3D Off

Arm description

Participants with advanced solid tumours with molecular markers which may indicate potential for response to p300/CBP inhibition received 75mg MF of CCS1477 OD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 75mg CCS1477 MF OD for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression.

Part E1 and E2: CCS1477 35mg BD-MF, 4D on and 3D Off

Arm description

Participants with advanced solid tumours with molecular markers which may indicate potential for response to p300/CBP inhibition received 35 mg - MF of CCS1477 BD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study intervention.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 35mg CCS1477 MF BD for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression.

Part F1: CCS1477 25mg BD-MF + Darolutamide, 4D on and 3D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 25mg MF, administered BD for 4 consecutive days followed by 3D off. In addition, participants received darolutamide 600 mg BD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 25mg CCS1477 MF, administered BD for 4 consecutive days followed by 3D off.

Investigational medicinal product name

Darolutamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received darolutamide 600 mg BD on a continuous schedule along with CCS1477, 25mg CCS1477 MF.

Part F1: CCS1477 35mg BD-MF + Darolutamide, 4 D on and 3D Off

Arm description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 35mg MF, administered BD for 4 consecutive days followed by 3D off. In addition, participants received darolutamide 600 mg BD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 35mg CCS1477 MF, administered BD for 4 consecutive days followed by 3D off.

Investigational medicinal product name

Darolutamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received darolutamide 600 mg BD on a continuous schedule along with CCS1477, 35mg CCS1477 MF.

Part H1: CCS1477 25mg BD-MF + Atezolizumab, 4D on and 3D Off

Arm description

Participants with non-small cell lung cancer (NSCLC) received the recommended Phase II dose of CCS1477, 25mg MF, administered BD for 4 consecutive days followed by 3D off. In addition, participants received Atezolizumab 840 mg (once every 2 weeks), 1200 mg (once every 3 weeks) and 1680 mg (once every 4 weeks) intravenously on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study intervention.

Arm type

Experimental

Investigational medicinal product name

CCS1477

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received 25mg CCS1477 MF, administered BD for 4 consecutive days followed by 3D off.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Participants received atezolizumab 840 mg (once every 2 weeks), 1200 mg (once every 3 weeks) and 1680 mg (once every 4 weeks) on a continuous schedule.

Number of subjects in period 1	Part A: CCS1477 100mg Once Daily	Part A: CCS1477 100mg, 2/Week	Part A: CCS1477 100mg, 3 Days on and 4 Days Off	Part A: CCS1477 100mg, 3/Week	Part A: CCS1477 50mg BD, 3 Days on and 4 Days Off	Part A: CCS1477 50mg Once Daily	Part A: CCS1477 25mg BD, Daily	Part A: CCS1477 25mg Once Daily	Part A: CCS1477 50mg, 4 Days on and 3 Days Off	Part A: CCS1477 50mg, 5 Days on and 2 Days Off	Part A: CCS1477(10mg-MF/20mg-MF) 50mg, 4 D On and 3 D Off	Part A: CCS147750 mg-MF, 4D on and 3D Off	Part A: CCS1477 30mg-MF,4 Days on and 3D Off	Part A: CCS1477 75mg-MF, 4Days on and 3Days Off	PartA: CCS1477 50mg BD-MF, 4D on and 3D Off	PartA: CCS1477 35mg BD-MF, 10 D on and 4 D Off	Part A: CCS1477 50mg OD-MF, 10D on and 4D Off	Part A and B1:CCS1477 35mg BD-MF, 4D on and 3D Off	Part C1: CCS1477 50mg - MF + Abiraterone, 4D on and 3D Off	Part C1: CCS1477 35mg-MF BD + Abiraterone, 4D on and 3D Off	Part D1: CCS1477 50mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS14777 75mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS1477 100mg-MF + Enzalutamide, 4 D on and 3D Off	Part D1: CCS1477 75mg-MF + Enzalutamide Daily	Part D1: CCS1477 75mg BD - MF + Enzalutamide, 4D on 3 D Off	Part D1:CCS1477 35mg and 75mg BD-MF+Enzalutamide, 4D on/3D Off	Part D1:CCS1477 50mg Daily-MF+Enzalutamide, 10 D on and 4D Off	Part E1: CCS1477 50mg Daily, 4D on and 3D Off	Part E1: CCS1477 50mg-MF, 4D on and 3D Off	Part E1: CCS1477 75mg-MF, 4D on and 3D Off	Part E1 and E2: CCS1477 35mg BD-MF, 4D on and 3D Off	Part F1: CCS1477 25mg BD-MF + Darolutamide, 4D on and 3D Off	Part F1: CCS1477 35mg BD-MF + Darolutamide, 4 D on and 3D Off	Part H1: CCS1477 25mg BD-MF + Atezolizumab, 4D on and 3D Off
Started	4	4	8	4	8	8	6	6	6	4	5	7	5	5	2	2	2	23	8	7	7	9	2	3	6	5	4	1	1	6	36	4	4	7
Completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Not completed	4	4	8	4	8	8	6	6	6	4	5	7	5	5	2	2	2	23	8	7	7	9	2	3	6	5	4	1	1	6	36	4	4	7
Adverse event, serious fatal	4	3	8	4	7	8	6	6	5	4	4	6	5	5	2	2	2	19	7	3	5	5	1	3	4	4	4	1	-	6	20	3	-	4
Consent withdrawn by subject	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Abiraterone/Enzalutamide Responder	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	2	3	1	-	-	-	-	-	-	-	-	-	-	-
Study terminated by sponsor	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	3	-	-	-	-	-	-	-	-	-	-	-	-	9	-	-	-
Unspecified	-	1	-	-	-	-	-	-	1	-	1	1	-	-	-	-	-	-	-	-	-	1	-	-	2	1	-	-	-	-	3	1	4	3
Lost to follow-up	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	1	1	-	-	-	-	-	-	-	-	-	-	-	4	-	-	-
Progressive disease	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	3	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Protocol deviation	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	-

Baseline characteristics

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Reporting group title

Part A: CCS1477 100mg Once Daily

Reporting group description

Reporting group title

Part A: CCS1477 100mg, 2/Week

Reporting group description

Reporting group title

Part A: CCS1477 100mg, 3 Days on and 4 Days Off

Reporting group description

Reporting group title

Part A: CCS1477 100mg, 3/Week

Reporting group description

Reporting group title

Part A: CCS1477 50mg BD, 3 Days on and 4 Days Off

Reporting group description

Reporting group title

Part A: CCS1477 50mg Once Daily

Reporting group description

Participants with mCRPC received 50 mg of CCS1477 OD orally until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Reporting group title

Part A: CCS1477 25mg BD, Daily

Reporting group description

Participants with mCRPC received 25 mg of CCS1477 BD orally until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Reporting group title

Part A: CCS1477 25mg Once Daily

Reporting group description

Participants with mCRPC received 25 mg of CCS1477 OD orally until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Reporting group title

Part A: CCS1477 50mg, 4 Days on and 3 Days Off

Reporting group description

Reporting group title

Part A: CCS1477 50mg, 5 Days on and 2 Days Off

Reporting group description

Reporting group title

Part A: CCS1477(10mg-MF/20mg-MF) 50mg, 4 D On and 3 D Off

Reporting group description

Reporting group title

Part A: CCS147750 mg-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part A: CCS1477 30mg-MF,4 Days on and 3D Off

Reporting group description

Reporting group title

Part A: CCS1477 75mg-MF, 4Days on and 3Days Off

Reporting group description

Reporting group title

PartA: CCS1477 50mg BD-MF, 4D on and 3D Off

Reporting group description

Reporting group title

PartA: CCS1477 35mg BD-MF, 10 D on and 4 D Off

Reporting group description

Reporting group title

Part A: CCS1477 50mg OD-MF, 10D on and 4D Off

Reporting group description

Reporting group title

Part A and B1:CCS1477 35mg BD-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part C1: CCS1477 50mg - MF + Abiraterone, 4D on and 3D Off

Reporting group description

Reporting group title

Part C1: CCS1477 35mg-MF BD + Abiraterone, 4D on and 3D Off

Reporting group description

Reporting group title

Part D1: CCS1477 50mg-MF + Enzalutamide, 4D on and 3D Off

Reporting group description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 50mg MF, administered orally OD for 4 consecutive days followed by 3D off. In addition, participants received enzalutamide 160 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Reporting group title

Part D1: CCS14777 75mg-MF + Enzalutamide, 4D on and 3D Off

Reporting group description

Reporting group title

Part D1: CCS1477 100mg-MF + Enzalutamide, 4 D on and 3D Off

Reporting group description

Reporting group title

Part D1: CCS1477 75mg-MF + Enzalutamide Daily

Reporting group description

Reporting group title

Part D1: CCS1477 75mg BD - MF + Enzalutamide, 4D on 3 D Off

Reporting group description

Reporting group title

Part D1:CCS1477 35mg and 75mg BD-MF+Enzalutamide, 4D on/3D Off

Reporting group description

Reporting group title

Part D1:CCS1477 50mg Daily-MF+Enzalutamide, 10 D on and 4D Off

Reporting group description

Reporting group title

Part E1: CCS1477 50mg Daily, 4D on and 3D Off

Reporting group description

Reporting group title

Part E1: CCS1477 50mg-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part E1: CCS1477 75mg-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part E1 and E2: CCS1477 35mg BD-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part F1: CCS1477 25mg BD-MF + Darolutamide, 4D on and 3D Off

Reporting group description

Reporting group title

Part F1: CCS1477 35mg BD-MF + Darolutamide, 4 D on and 3D Off

Reporting group description

Reporting group title

Part H1: CCS1477 25mg BD-MF + Atezolizumab, 4D on and 3D Off

Reporting group description

Reporting group values	Part A: CCS1477 100mg Once Daily	Part A: CCS1477 100mg, 2/Week	Part A: CCS1477 100mg, 3 Days on and 4 Days Off	Part A: CCS1477 100mg, 3/Week	Part A: CCS1477 50mg BD, 3 Days on and 4 Days Off	Part A: CCS1477 50mg Once Daily	Part A: CCS1477 25mg BD, Daily	Part A: CCS1477 25mg Once Daily	Part A: CCS1477 50mg, 4 Days on and 3 Days Off	Part A: CCS1477 50mg, 5 Days on and 2 Days Off	Part A: CCS1477(10mg-MF/20mg-MF) 50mg, 4 D On and 3 D Off	Part A: CCS147750 mg-MF, 4D on and 3D Off	Part A: CCS1477 30mg-MF,4 Days on and 3D Off	Part A: CCS1477 75mg-MF, 4Days on and 3Days Off	PartA: CCS1477 50mg BD-MF, 4D on and 3D Off	PartA: CCS1477 35mg BD-MF, 10 D on and 4 D Off	Part A: CCS1477 50mg OD-MF, 10D on and 4D Off	Part A and B1:CCS1477 35mg BD-MF, 4D on and 3D Off	Part C1: CCS1477 50mg - MF + Abiraterone, 4D on and 3D Off	Part C1: CCS1477 35mg-MF BD + Abiraterone, 4D on and 3D Off	Part D1: CCS1477 50mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS14777 75mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS1477 100mg-MF + Enzalutamide, 4 D on and 3D Off	Part D1: CCS1477 75mg-MF + Enzalutamide Daily	Part D1: CCS1477 75mg BD - MF + Enzalutamide, 4D on 3 D Off	Part D1:CCS1477 35mg and 75mg BD-MF+Enzalutamide, 4D on/3D Off	Part D1:CCS1477 50mg Daily-MF+Enzalutamide, 10 D on and 4D Off	Part E1: CCS1477 50mg Daily, 4D on and 3D Off	Part E1: CCS1477 50mg-MF, 4D on and 3D Off	Part E1: CCS1477 75mg-MF, 4D on and 3D Off	Part E1 and E2: CCS1477 35mg BD-MF, 4D on and 3D Off	Part F1: CCS1477 25mg BD-MF + Darolutamide, 4D on and 3D Off	Part F1: CCS1477 35mg BD-MF + Darolutamide, 4 D on and 3D Off	Part H1: CCS1477 25mg BD-MF + Atezolizumab, 4D on and 3D Off	Total
Number of subjects	4	4	8	4	8	8	6	6	6	4	5	7	5	5	2	2	2	23	8	7	7	9	2	3	6	5	4	1	1	6	36	4	4	7	219
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Adults (18-64 years)	1	1	3	0	0	2	2	1	0	2	2	1	0	0	0	0	0	2	1	1	1	0	0	1	2	1	3	0	1	4	20	1	0	1	54
From 65-84 years	3	3	5	4	8	6	4	5	6	2	3	6	5	5	2	2	2	21	7	6	6	9	2	2	4	4	1	1	0	2	16	3	4	6	165
85 years and over	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gender categorical
Units: Subjects
Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	4	24	0	0	4	33
Male	4	4	8	4	8	8	6	6	6	4	5	7	5	5	2	2	2	23	8	7	7	9	2	3	6	5	4	1	0	2	12	4	4	3	186
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	3	1	0	0	8
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	3
White	4	4	8	4	8	7	5	6	6	4	5	6	5	5	2	2	2	23	8	7	6	9	2	2	6	5	4	1	1	6	21	3	4	6	197
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	10	0	0	1	11

End points

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Reporting group title

Part A: CCS1477 100mg Once Daily

Reporting group description

Reporting group title

Part A: CCS1477 100mg, 2/Week

Reporting group description

Reporting group title

Part A: CCS1477 100mg, 3 Days on and 4 Days Off

Reporting group description

Reporting group title

Part A: CCS1477 100mg, 3/Week

Reporting group description

Reporting group title

Part A: CCS1477 50mg BD, 3 Days on and 4 Days Off

Reporting group description

Reporting group title

Part A: CCS1477 50mg Once Daily

Reporting group description

Participants with mCRPC received 50 mg of CCS1477 OD orally until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Reporting group title

Part A: CCS1477 25mg BD, Daily

Reporting group description

Participants with mCRPC received 25 mg of CCS1477 BD orally until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study treatment.

Reporting group title

Part A: CCS1477 25mg Once Daily

Reporting group description

Participants with mCRPC received 25 mg of CCS1477 OD orally until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.

Reporting group title

Part A: CCS1477 50mg, 4 Days on and 3 Days Off

Reporting group description

Reporting group title

Part A: CCS1477 50mg, 5 Days on and 2 Days Off

Reporting group description

Reporting group title

Part A: CCS1477(10mg-MF/20mg-MF) 50mg, 4 D On and 3 D Off

Reporting group description

Reporting group title

Part A: CCS147750 mg-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part A: CCS1477 30mg-MF,4 Days on and 3D Off

Reporting group description

Reporting group title

Part A: CCS1477 75mg-MF, 4Days on and 3Days Off

Reporting group description

Reporting group title

PartA: CCS1477 50mg BD-MF, 4D on and 3D Off

Reporting group description

Reporting group title

PartA: CCS1477 35mg BD-MF, 10 D on and 4 D Off

Reporting group description

Reporting group title

Part A: CCS1477 50mg OD-MF, 10D on and 4D Off

Reporting group description

Reporting group title

Part A and B1:CCS1477 35mg BD-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part C1: CCS1477 50mg - MF + Abiraterone, 4D on and 3D Off

Reporting group description

Reporting group title

Part C1: CCS1477 35mg-MF BD + Abiraterone, 4D on and 3D Off

Reporting group description

Reporting group title

Part D1: CCS1477 50mg-MF + Enzalutamide, 4D on and 3D Off

Reporting group description

Participants with mCRPC received the recommended Phase II dose of CCS1477, 50mg MF, administered orally OD for 4 consecutive days followed by 3D off. In addition, participants received enzalutamide 160 mg orally OD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study therapy.

Reporting group title

Part D1: CCS14777 75mg-MF + Enzalutamide, 4D on and 3D Off

Reporting group description

Reporting group title

Part D1: CCS1477 100mg-MF + Enzalutamide, 4 D on and 3D Off

Reporting group description

Reporting group title

Part D1: CCS1477 75mg-MF + Enzalutamide Daily

Reporting group description

Reporting group title

Part D1: CCS1477 75mg BD - MF + Enzalutamide, 4D on 3 D Off

Reporting group description

Reporting group title

Part D1:CCS1477 35mg and 75mg BD-MF+Enzalutamide, 4D on/3D Off

Reporting group description

Reporting group title

Part D1:CCS1477 50mg Daily-MF+Enzalutamide, 10 D on and 4D Off

Reporting group description

Reporting group title

Part E1: CCS1477 50mg Daily, 4D on and 3D Off

Reporting group description

Reporting group title

Part E1: CCS1477 50mg-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part E1: CCS1477 75mg-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part E1 and E2: CCS1477 35mg BD-MF, 4D on and 3D Off

Reporting group description

Reporting group title

Part F1: CCS1477 25mg BD-MF + Darolutamide, 4D on and 3D Off

Reporting group description

Reporting group title

Part F1: CCS1477 35mg BD-MF + Darolutamide, 4 D on and 3D Off

Reporting group description

Reporting group title

Part H1: CCS1477 25mg BD-MF + Atezolizumab, 4D on and 3D Off

Reporting group description

Subject analysis set title

Part A and B1: CCS1477 Monotherapy

Subject analysis set type

Safety analysis

Subject analysis set description

Participants with metastatic castration-resistant prostate cancer (mCRPC) received CCS1477 as monotherapy in part A and B1 of the study. CCS1477 was administered orally at 100mg OD or 100mg, 2/week or 100mg, 3 days on and 4 days off or 100mg, 3/week or 50mg BD, 3D on and 4D off or 50mg OD or 25mg BD, daily or 25mg OD or 50mg, 4D on and 3D off or 50mg, 5D on and 2D off or (10mg-MF/20mg-MF) 50mg, 4D on and 3D off or 50mg-MF, 4 days on and 3D off or30mg - MF, 4D on and 3D off or 75mg -MF, 4D on and 3D off or 35mg BD-MF, 4D on and 3D off or 50mg BD-MF, 4D on and 3D off or 35mg BD-MF, 10D on and 4D off or 50mg OD-MF, 10D on and 4D off or 35mg BD-MF, 4D on and 3D off. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study intervention.

Subject analysis set title

Part C1: CCS1477 in Combination With Abiraterone

Subject analysis set type

Safety analysis

Subject analysis set description

Participants with metastatic castration‑resistant prostate cancer (mCRPC) received the recommended Phase II dose of CCS1477, 50 mg MF OD or 35 mg MF, administered orally BD, for 4 consecutive days followed by 3 days off. In addition, participants received abiraterone 1000 mg orally OD. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study intervention.

Subject analysis set title

Part D1: CCS1477 in Combination With Enzalutamide

Subject analysis set type

Safety analysis

Subject analysis set description

Participants with metastatic castration resistant prostate cancer (mCRPC) received the recommended Phase II dose of CCS1477: OD at 50mg, 75 mg, or 100 mg for 4 days on/3 days off; 75 mg OD continuously; 75 mg BD continuously; or BD at 35 mg or 75 mg for 4D on/3D off or 50 mg 10 day on/4 day off. In addition, participants received enzalutamide 160 mg orally once daily. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study intervention.

Subject analysis set title

Part E1 and E2: CCS1477 Monotherapy

Subject analysis set type

Safety analysis

Subject analysis set description

Participants with advanced solid tumors with molecular markers which may indicate potential for response to p300/CBP inhibition received 50mg daily, 4D on and 3D off or 50mg MF, 4D on and 3D off, or 75mg-MF, 4D on and 3D off, 35mg BD-MF, 4D on and 3D off or 35mg BD modified formulation, 4D on and 3D off of CCS1477 OD orally for 4 consecutive days, followed by 3D off, and continued on this schedule until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study intervention.

Subject analysis set title

Part F1: CCS1477 in Combination With Darolutamide

Subject analysis set type

Safety analysis

Subject analysis set description

Participants with metastatic castration‑resistant prostate cancer (mCRPC) received the recommended Phase II dose of CCS1477, 25 mg or 35 mg MF, administered BD for 4 consecutive days followed by 3D off. In addition, participants received darolutamide 600mg BD on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study intervention.

Subject analysis set title

Part H1: CCS1477 in Combination With Atezolizumab

Subject analysis set type

Safety analysis

Subject analysis set description

Participants with non-small cell lung cancer (NSCLC) received the recommended Phase II dose of CCS1477, 25 mg MF, administered BD for 4 consecutive days followed by 3D off. In addition, participants received Atezolizumab 840 mg (once every 2 weeks), 1200 mg (once every 3 weeks) and 1680 mg (once every 4 weeks) intravenously on a continuous schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or any other criterion for discontinuation of study intervention.

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Withdrawal

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End point title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Withdrawal ^[1]

End point description

Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study intervention, which does not necessarily have a causal relationship with the treatment. Serious AE (SAE) was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs were defined as those events with onset dates/time occurring after study intervention administration or events that worsen after study intervention administration. TEAEs included serious TEAEs and non-serious TEAEs. Number of participants with TEAEs leading to withdrawal of study intervention was also reported. Safety Analysis Set (SAF) included all participants who received at least 1 dose of CCS1477.

End point type

Primary

End point timeframe

From signing informed consent until the end of the follow-up period (Up to 363 weeks)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.

End point values	Part A: CCS1477 100mg Once Daily	Part A: CCS1477 100mg, 2/Week	Part A: CCS1477 100mg, 3 Days on and 4 Days Off	Part A: CCS1477 100mg, 3/Week	Part A: CCS1477 50mg BD, 3 Days on and 4 Days Off	Part A: CCS1477 50mg Once Daily	Part A: CCS1477 25mg BD, Daily	Part A: CCS1477 25mg Once Daily	Part A: CCS1477 50mg, 4 Days on and 3 Days Off	Part A: CCS1477 50mg, 5 Days on and 2 Days Off	Part A: CCS1477(10mg-MF/20mg-MF) 50mg, 4 D On and 3 D Off	Part A: CCS147750 mg-MF, 4D on and 3D Off	Part A: CCS1477 30mg-MF,4 Days on and 3D Off	Part A: CCS1477 75mg-MF, 4Days on and 3Days Off	PartA: CCS1477 50mg BD-MF, 4D on and 3D Off	PartA: CCS1477 35mg BD-MF, 10 D on and 4 D Off	Part A: CCS1477 50mg OD-MF, 10D on and 4D Off	Part A and B1:CCS1477 35mg BD-MF, 4D on and 3D Off	Part C1: CCS1477 50mg - MF + Abiraterone, 4D on and 3D Off	Part C1: CCS1477 35mg-MF BD + Abiraterone, 4D on and 3D Off	Part D1: CCS1477 50mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS14777 75mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS1477 100mg-MF + Enzalutamide, 4 D on and 3D Off	Part D1: CCS1477 75mg-MF + Enzalutamide Daily	Part D1: CCS1477 75mg BD - MF + Enzalutamide, 4D on 3 D Off	Part D1:CCS1477 35mg and 75mg BD-MF+Enzalutamide, 4D on/3D Off	Part D1:CCS1477 50mg Daily-MF+Enzalutamide, 10 D on and 4D Off	Part E1: CCS1477 50mg Daily, 4D on and 3D Off	Part E1: CCS1477 50mg-MF, 4D on and 3D Off	Part E1: CCS1477 75mg-MF, 4D on and 3D Off	Part E1 and E2: CCS1477 35mg BD-MF, 4D on and 3D Off	Part F1: CCS1477 25mg BD-MF + Darolutamide, 4D on and 3D Off	Part F1: CCS1477 35mg BD-MF + Darolutamide, 4 D on and 3D Off	Part H1: CCS1477 25mg BD-MF + Atezolizumab, 4D on and 3D Off
Number of subjects analysed	4	4	8	4	8	8	6	6	6	4	5	7	5	5	2	2	2	23	8	7	7	9	2	3	6	5	4	1	1	6	36	4	4	7
Units: participants
TEAEs	4	3	8	4	8	7	6	6	6	4	5	7	5	5	2	2	2	23	8	7	6	8	2	3	6	5	4	1	1	6	36	4	4	7
SAEs	4	1	5	3	4	4	1	1	1	2	3	3	0	4	1	1	1	6	4	3	1	1	0	2	1	1	0	0	0	0	15	0	1	5
TEAEs leading to withdrawal of CCS1477	2	0	4	1	1	3	0	0	0	0	0	0	0	0	0	0	1	1	2	3	0	1	0	0	0	0	0	0	0	0	2	0	0	2

No statistical analyses for this end point

Primary: Number of Participants With Worst Shift in Laboratory Data-Hematology According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades

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End point title

Number of Participants With Worst Shift in Laboratory Data-Hematology According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades ^[2]

End point description

Adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 = death related to the adverse event. Number of participants with worst shift in hematology according to Common Terminology Criteria for Adverse Events (CTCAE) grades were reported. SAF included all participants who received at least 1 dose of CCS1477.

End point type

Primary

End point timeframe

From first dose of study drug in Cycle 1 up to and including 28 days after last dose of study intervention (Up to 363 weeks) (Cycle length was 4 weeks for Cycles 1–6 and 6 weeks for Cycle 7 and subsequent cycles)

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: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part E1 and E2: CCS1477 Monotherapy	Part F1: CCS1477 in Combination With Darolutamide	Part H1: CCS1477 in Combination With Atezolizumab
Number of subjects analysed	109	15	36	44	8	7
Units: participants
Platelets, Grade 0 to Grade 1	24	5	2	11	0	2
Platelets, Grade 0 to Grade 2	4	0	0	2	0	0
Platelets, Grade 0 to Grade 3	3	0	0	0	0	0
Platelets, Grade 0 to Grade 4	3	0	0	0	0	0
Platelets, Grade 1 to Grade 2	2	0	0	0	0	0
Platelets, Grade 1 to Grade 3	2	0	0	0	0	0
Platelets, Grade 1 to Grade 4	1	0	0	0	0	0
Eosinophils, Grade 0 to Grade 1	21	3	12	0	3	2
Neutrophils, Grade 0 to Grade 1	4	0	0	1	1	0
Neutrophils, Grade 0 to Grade 2	1	0	0	0	0	0
Neutrophils, Grade 0 to Grade 3	1	0	0	0	0	0
Neutrophils, Grade 1 to Grade 2	1	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Participants With Worst Shift in Laboratory Data-Biochemistry According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades

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End point title

Number of Participants With Worst Shift in Laboratory Data-Biochemistry According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades ^[3]

End point description

Adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 = death related to the adverse event. Number of participants with worst shift in biochemistry according to Common Terminology Criteria for Adverse Events (CTCAE) grades were reported. SAF included all participants who received at least 1 dose of CCS1477. SAF included all participants who received at least 1 dose of CCS1477.

End point type

Primary

End point timeframe

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: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part E1 and E2: CCS1477 Monotherapy	Part F1: CCS1477 in Combination With Darolutamide	Part H1: CCS1477 in Combination With Atezolizumab
Number of subjects analysed	109	15	36	44	8	7
Units: participants
Albumin, Grade 0 to Grade 1	12	2	5	7	1	2
Albumin, Grade 0 to Grade 2	10	0	0	3	0	1
Albumin, Grade 1 to Grade 2	0	0	3	1	1	1
Alkaline Phosphatase, Grade 0 to Grade 1	25	2	7	3	2	1
Alkaline Phosphatase, Grade 0 to Grade 2	4	1	3	1	0	0
Alkaline Phosphatase, Grade 0 to Grade 3	1	0	1	0	0	1
Alanine Aminotransferase, Grade 0 to Grade 1	12	0	0	7	0	2
Alanine Aminotransferase, Grade 0 to Grade 2	0	0	0	1	0	0
Aspartate Aminotransferase, Grade 0 to Grade 1	25	4	4	11	2	2
Aspartate Aminotransferase, Grade 0 to Grade 2	1	0	0	1	0	1
Aspartate Aminotransferase, Grade 0 to Grade 3	0	0	0	1	0	0
Creatinine, Grade 0 to Grade 1	13	2	4	5	1	2
Creatinine, Grade 0 to Grade 2	18	0	1	3	1	1
Creatinine, Grade 0 to Grade 3	3	0	0	0	0	0
Creatinine, Grade 0 to Grade 4	0	0	0	1	0	0
Creatinine, Grade 1 to Grade 2	3	0	0	0	0	0
Creatinine, Grade 2 to Grade 3	1	0	0	0	0	0
Lactate Dehydrogenase, Grade 0 to Grade 1	35	6	9	9	4	2
Total Bilirubin, Grade 0 to Grade 1	7	1	4	3	0	1
Total Bilirubin, Grade 0 to Grade 2	2	0	0	2	0	0
Total Bilirubin, Grade 0 to Grade 3	2	0	1	0	0	0
Total Bilirubin, Grade 0 to Grade 4	0	0	0	2	0	0

No statistical analyses for this end point

Primary: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters - Urinalysis

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End point title

Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters - Urinalysis ^[4]

End point description

The urinalysis measurements included glucose, protein and blood. Number of participants with clinically significant changes from baseline in urinalysis values were reported. Clinically Significance was decided by investigator. SAF included all participants who received at least 1 dose of CCS1477.

End point type

Primary

End point timeframe

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: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part E1 and E2: CCS1477 Monotherapy	Part F1: CCS1477 in Combination With Darolutamide	Part H1: CCS1477 in Combination With Atezolizumab
Number of subjects analysed	109	15	36	44	8	7
Units: participants	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

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End point title

Number of Participants With Clinically Significant Change From Baseline in Vital Signs ^[5]

End point description

The vital signs measurements included blood pressure, heart rate, respiration rate and temperature. Number of participants with clinically significant changes from baseline in vital signs values were reported. Clinically Significance was decided by investigator. SAF included all participants who received at least 1 dose of CCS1477.

End point type

Primary

End point timeframe

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: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part E1 and E2: CCS1477 Monotherapy	Part F1: CCS1477 in Combination With Darolutamide	Part H1: CCS1477 in Combination With Atezolizumab
Number of subjects analysed	109	15	36	44	8	7
Units: participants	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Participants With Worst Shift in QTcF According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades

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End point title

Number of Participants With Worst Shift in QTcF According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades ^[6]

End point description

Twelve-lead Electrocardiograms (ECGs) were obtained after the participant was in semi-supine for 5 minutes. Three ECGs were taken at each timepoint at about 1-minute intervals. QTcF was calculated using the Fridericia formula: QTcF = QT ÷ RR^(1/3), where QT is the measured QT interval in milliseconds and RR is the interval between two consecutive R waves on the ECG expressed in seconds. It was categorized as less than equal to (<=) 450 milliseconds (msec), more than (>) 450 to <=480 msec, > 480 to <= 500 msec and > 500 msec. SAF included all participants who received at least 1 dose of CCS1477.

End point type

Primary

End point timeframe

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part E1 and E2: CCS1477 Monotherapy	Part F1: CCS1477 in Combination With Darolutamide	Part H1: CCS1477 in Combination With Atezolizumab
Number of subjects analysed	109	15	36	44	8	7
Units: participants
<= 450 msec to > 450 - <= 480 msec	20	2	9	4	2	2
<= 450 msec to > 480 - <= 500 msec	1	1	2	1	0	0
<= 450 msec to > 500 msec	1	0	0	4	0	0
> 450 - <= 480 msec to > 480 - <= 500 msec	1	0	2	0	0	1
> 450 - <= 480 msec to > 500 msec	2	0	2	0	0	0

No statistical analyses for this end point

Secondary: Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Response in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)

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End point title

Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Response in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)

End point description

Best percentage change from baseline was defined as the largest percentage reduction in PSA levels or the smallest percentage increase in PSA levels in the absence of a reduction. The PSA analysis set was applicable for mCRPC participants only and includes all participants who received at least one dose of CCS1477 from Cycle 1 Day 1 onwards and had a PSA measurement at baseline.

End point type

Secondary

End point timeframe

At Baseline, Cycle 1 Day 1, Day 8, Day 15, Day 22 and Day 1 of every cycle from cycle 2 onwards until treatment discontinuation (Up to 363 weeks) (Cycle length was 4 weeks for Cycles 1–6 and 6 weeks for Cycle 7 and subsequent cycles)

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part F1: CCS1477 in Combination With Darolutamide
Number of subjects analysed	108	15	36	8
Units: percentage change from baseline
arithmetic mean (standard deviation)	5.39 ( 35.650 )	-8.88 ( 39.560 )	-2.85 ( 27.712 )	-0.89 ( 30.687 )

No statistical analyses for this end point

Secondary: Number of Participants With CTC Response

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End point title

Number of Participants With CTC Response

End point description

CTC response was defined as a change from unfavourable (five or more cells per 7.5 mL of blood) at baseline to favourable (four or fewer cells per 7.5 mL) post treatment. Number of participants with overall response were reported. A participant was determined as having an overall CTC response if they had at least one post baseline assessment of 'CTC response'. The CTC analysis set included all participants who received at least one dose of CCS1477 from Cycle 1 Day 1 onwards and had measurable CTCs at baseline defined as more than equal to 5 cells per 7.5 mL of blood.

End point type

Secondary

End point timeframe

From Baseline, Cycle 1 Day 1 (Predose), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1 up to disease progression or treatment discontinuation (Up to 363 weeks) (Cycle length was 4 weeks for Cycles 1–6 and 6 weeks for Cycle 7 and subsequent cycles)

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part E1 and E2: CCS1477 Monotherapy
Number of subjects analysed	60	11	12	4
Units: participants	6	1	5	0

No statistical analyses for this end point

Secondary: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

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End point title

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

End point description

Objective response is defined as any participant with measurable disease who has a best overall response of Partial Response (PR) or Complete Response (CR). CR is defined as the disappearance of all Target Lesions (TLs) since baseline. PR is defined as At least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters. SAF included all participants who received at least 1 dose of CCS1477.

End point type

Secondary

End point timeframe

From day of study intervention in Cycle 1 until progression or censoring date in the absence of progression (Up to 363 weeks) (Cycle length was 4 weeks for Cycles 1–6 and 6 weeks for Cycle 7 and subsequent cycles)

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part E1 and E2: CCS1477 Monotherapy	Part F1: CCS1477 in Combination With Darolutamide	Part H1: CCS1477 in Combination With Atezolizumab
Number of subjects analysed	109	15	36	44	8	7
Units: participants	1	1	0	0	1	0

No statistical analyses for this end point

Secondary: Radiological Progression Free Survival (rPFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

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End point title

Radiological Progression Free Survival (rPFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

End point description

Radiological progression free survival (rPFS) was defined as the time from the start of treatment with CCS1477 in Cycle 1 until the earliest objective disease progression defined by RECIST 1.1, Prostate Cancer Clinical Trial Working Group 3 (PCWG-3) bone progression or death by any cause in the absence of progression, regardless of whether the participants withdraws from study medication or receives another anti-cancer therapy prior to progression. Kaplan - Meier estimate was used to calculate the rPFS. SAF included all participants who received at least 1 dose of CCS1477. 99999 signifies the number of events were not sufficient to calculate the upper limit of the confidence interval.

End point type

Secondary

End point timeframe

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part E1 and E2: CCS1477 Monotherapy	Part F1: CCS1477 in Combination With Darolutamide	Part H1: CCS1477 in Combination With Atezolizumab
Number of subjects analysed	109	15	36	44	8	7
Units: months
median (confidence interval 90%)	2.8 (1.9 to 3.5)	1.9 (1.6 to 3.5)	3.6 (1.9 to 5.5)	1.9 (1.7 to 2.3)	2.8 (1.9 to 8.4)	2.9 (1.7 to 99999)

No statistical analyses for this end point

Secondary: Overall Survival (OS)

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End point title

Overall Survival (OS)

End point description

Overall survival is defined as the time from the start of treatment with CCS1477 in Cycle 1 until death due to any cause. SAF included all participants who received at least 1 dose of CCS1477. 99999 signifies the number of events were not sufficient to calculate the upper limit of the confidence interval.

End point type

Secondary

End point timeframe

From start of treatment until death (Up to 363 weeks)

End point values	Part A and B1: CCS1477 Monotherapy	Part C1: CCS1477 in Combination With Abiraterone	Part D1: CCS1477 in Combination With Enzalutamide	Part E1 and E2: CCS1477 Monotherapy	Part F1: CCS1477 in Combination With Darolutamide	Part H1: CCS1477 in Combination With Atezolizumab
Number of subjects analysed	109	15	36	44	8	7
Units: months
median (confidence interval 90%)	10.5 (9.30 to 12.00)	14.2 (7.80 to 19.50)	15.4 (10.90 to 17.10)	10.2 (5.80 to 12.60)	13.8 (13.70 to 99999)	7.2 (1.80 to 99999)

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax)

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End point title

Maximum Observed Plasma Concentration (Cmax)

End point description

Cmax was obtained directly from concentration versus time curve. The Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of CCS1477 from C1D1 onwards and have at least 1 measured CCS1477 PK concentration post dose from C1D1 onwards with no important protocol deviations that would impact PK. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. 99999 signifies geometric coefficient of variation could not be calculated since the number of participants evaluable was 1. Here, "n" signifies participants evaluable at specified timepoints. For C1D1: n=4,4,8,4,8,8,6,6,5,4,5,7,5,5,2,2,2,23,8,6,7,9,2,3,6,5,4,7,9,2,3,4,4,7 and for C2D3: n=0,0,0,1,0,5,0,0,0,6,3,0,3,4,3,1,1,0,14,0,0,0,2,0,0,4,3,0,0,0,0,0,0,0,0. 88888 signifies data was not evaluable as no participant was analyzed for this timepoint.

End point type

Secondary

End point timeframe

Cycle 1 Day 1 (C1D1) and Cycle 2 Day 3 (C2D3) (Cycle length was 4 weeks)

End point values	Part A: CCS1477 100mg Once Daily	Part A: CCS1477 100mg, 2/Week	Part A: CCS1477 100mg, 3 Days on and 4 Days Off	Part A: CCS1477 100mg, 3/Week	Part A: CCS1477 50mg BD, 3 Days on and 4 Days Off	Part A: CCS1477 50mg Once Daily	Part A: CCS1477 25mg BD, Daily	Part A: CCS1477 25mg Once Daily	Part A: CCS1477 50mg, 4 Days on and 3 Days Off	Part A: CCS1477 50mg, 5 Days on and 2 Days Off	Part A: CCS1477(10mg-MF/20mg-MF) 50mg, 4 D On and 3 D Off	Part A: CCS147750 mg-MF, 4D on and 3D Off	Part A: CCS1477 30mg-MF,4 Days on and 3D Off	Part A: CCS1477 75mg-MF, 4Days on and 3Days Off	PartA: CCS1477 50mg BD-MF, 4D on and 3D Off	PartA: CCS1477 35mg BD-MF, 10 D on and 4 D Off	Part A: CCS1477 50mg OD-MF, 10D on and 4D Off	Part A and B1:CCS1477 35mg BD-MF, 4D on and 3D Off	Part C1: CCS1477 50mg - MF + Abiraterone, 4D on and 3D Off	Part C1: CCS1477 35mg-MF BD + Abiraterone, 4D on and 3D Off	Part D1: CCS1477 50mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS14777 75mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS1477 100mg-MF + Enzalutamide, 4 D on and 3D Off	Part D1: CCS1477 75mg-MF + Enzalutamide Daily	Part D1: CCS1477 75mg BD - MF + Enzalutamide, 4D on 3 D Off	Part D1:CCS1477 35mg and 75mg BD-MF+Enzalutamide, 4D on/3D Off	Part D1:CCS1477 50mg Daily-MF+Enzalutamide, 10 D on and 4D Off	Part E1: CCS1477 50mg Daily, 4D on and 3D Off	Part E1: CCS1477 50mg-MF, 4D on and 3D Off	Part E1: CCS1477 75mg-MF, 4D on and 3D Off	Part E1 and E2: CCS1477 35mg BD-MF, 4D on and 3D Off	Part F1: CCS1477 25mg BD-MF + Darolutamide, 4D on and 3D Off	Part F1: CCS1477 35mg BD-MF + Darolutamide, 4 D on and 3D Off	Part H1: CCS1477 25mg BD-MF + Atezolizumab, 4D on and 3D Off
Number of subjects analysed	4	4	8	4	8	8	6	6	6	4	5	7	5	5	2	2	2	23	8	7	7	9	2	3	6	5	4	1	1	6	36	4	4	7
Units: nanogram/milliliter (ng/ml
geometric mean (geometric coefficient of variation)
Cycle 1 - Day 1	708.4 ( 64.0 )	1434.1 ( 104.8 )	823.1 ( 29.3 )	628.5 ( 83.9 )	485.7 ( 66.6 )	375.5 ( 36.9 )	132.1 ( 31.3 )	237.6 ( 65.2 )	303.7 ( 41.5 )	351.4 ( 44.7 )	132.6 ( 68.6 )	968.6 ( 61.7 )	515.4 ( 22.7 )	1462.9 ( 56.2 )	682.9 ( 154.2 )	820.0 ( 56.5 )	893.7 ( 104.4 )	557.5 ( 69.5 )	248.0 ( 104.1 )	522.4 ( 72.5 )	13484.5 ( 68.6 )	14717.1 ( 74.1 )	15440.9 ( 23.6 )	11271.5 ( 97.0 )	15420.6 ( 20.6 )	3449.1 ( 13.2 )	17843.4 ( 6.9 )	259.1 ( 35.4 )	344.3 ( 55.4 )	301.0 ( 102.9 )	427.1 ( 67.5 )	3838.6 ( 16.8 )	6140.8 ( 29.6 )	702.8 ( 55.6 )
Cycle 2 - Day 3	88888 ( 88888 )	88888 ( 88888 )	813 ( 99999 )	88888 ( 88888 )	676.9 ( 58.5 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	531.5 ( 51.5 )	545.9 ( 51.1 )	88888 ( 88888 )	847.1 ( 55.6 )	670.5 ( 21.0 )	1515.0 ( 46.6 )	1720.0 ( 99999 )	1160.0 ( 99999 )	88888 ( 88888 )	633.6 ( 71.6 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	16240.7 ( 4.8 )	88888 ( 88888 )	88888 ( 88888 )	19770.9 ( 32.3 )	16272.2 ( 7.2 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-24)

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End point title

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-24)

End point description

AUC0-24 is defined as the area under the concentration-time curve (AUC) from time zero (= dosing time) to 24 hours. AUC0-24 was calculated using the mixed log-linear trapezoidal rule. The PK analysis set included all participants who received at least 1 dose of CCS1477 from C1D1 onwards and have at least 1 measured CCS1477 PK concentration post dose from C1D1 onwards with no important protocol deviations that would impact PK. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. 99999 signifies geometric coefficient of variation could not be calculated since the number of participants evaluable was 1. Here, "n" signifies participants evaluable at specified timepoints. For C1D1: n=4,4,8,4,8,8,6,6,5,4,5,7,5,5,2,2,2,23,8,6,7,9,2,3,6,5,4,1,1,6,28,4,4,7 and for C2D3: n=0,0,1,0,0,0,0,0,6,3,0,3,4,3,0,0,0,0,0,0,0,2,0,0,4,3,0,0,0,0,0,0,0,0. 88888 signifies data was not evaluable as no participant was analyzed for this time point.

End point type

Secondary

End point timeframe

Cycle 1 Day 1 and Cycle 2 Day 3 (Cycle length was 4 weeks)

End point values	Part A: CCS1477 100mg Once Daily	Part A: CCS1477 100mg, 2/Week	Part A: CCS1477 100mg, 3 Days on and 4 Days Off	Part A: CCS1477 100mg, 3/Week	Part A: CCS1477 50mg BD, 3 Days on and 4 Days Off	Part A: CCS1477 50mg Once Daily	Part A: CCS1477 25mg BD, Daily	Part A: CCS1477 25mg Once Daily	Part A: CCS1477 50mg, 4 Days on and 3 Days Off	Part A: CCS1477 50mg, 5 Days on and 2 Days Off	Part A: CCS1477(10mg-MF/20mg-MF) 50mg, 4 D On and 3 D Off	Part A: CCS147750 mg-MF, 4D on and 3D Off	Part A: CCS1477 30mg-MF,4 Days on and 3D Off	Part A: CCS1477 75mg-MF, 4Days on and 3Days Off	PartA: CCS1477 50mg BD-MF, 4D on and 3D Off	PartA: CCS1477 35mg BD-MF, 10 D on and 4 D Off	Part A: CCS1477 50mg OD-MF, 10D on and 4D Off	Part A and B1:CCS1477 35mg BD-MF, 4D on and 3D Off	Part C1: CCS1477 50mg - MF + Abiraterone, 4D on and 3D Off	Part C1: CCS1477 35mg-MF BD + Abiraterone, 4D on and 3D Off	Part D1: CCS1477 50mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS14777 75mg-MF + Enzalutamide, 4D on and 3D Off	Part D1: CCS1477 100mg-MF + Enzalutamide, 4 D on and 3D Off	Part D1: CCS1477 75mg-MF + Enzalutamide Daily	Part D1: CCS1477 75mg BD - MF + Enzalutamide, 4D on 3 D Off	Part D1:CCS1477 35mg and 75mg BD-MF+Enzalutamide, 4D on/3D Off	Part D1:CCS1477 50mg Daily-MF+Enzalutamide, 10 D on and 4D Off	Part E1: CCS1477 50mg Daily, 4D on and 3D Off	Part E1: CCS1477 50mg-MF, 4D on and 3D Off	Part E1: CCS1477 75mg-MF, 4D on and 3D Off	Part E1 and E2: CCS1477 35mg BD-MF, 4D on and 3D Off	Part F1: CCS1477 25mg BD-MF + Darolutamide, 4D on and 3D Off	Part F1: CCS1477 35mg BD-MF + Darolutamide, 4 D on and 3D Off	Part H1: CCS1477 25mg BD-MF + Atezolizumab, 4D on and 3D Off
Number of subjects analysed	4	4	8	4	8	8	6	6	6	4	5	7	5	5	2	2	2	23	8	7	7	9	2	3	6	5	4	1	1	6	36	4	4	7
Units: hoursnanograms per milliliter (hng/mL)
geometric mean (geometric coefficient of variation)
Cycle 1 - Day 1	5750.4 ( 197.5 )	10447.9 ( 137.3 )	6755.0 ( 47.1 )	5944.7 ( 95.7 )	3790.5 ( 141.8 )	2542.0 ( 59.4 )	829.2 ( 81.8 )	88888 ( 88888 )	1776.1 ( 42.1 )	3697.1 ( 58.3 )	646.4 ( 46.4 )	4195.7 ( 97.2 )	2096.7 ( 32.0 )	6594.1 ( 89.5 )	2873.6 ( 360.0 )	3247.1 ( 0.4 )	3732.8 ( 199.4 )	3299.2 ( 76.9 )	1218.1 ( 93.4 )	2492.1 ( 51.7 )	249370.4 ( 98.4 )	269964.2 ( 99.4 )	292439.6 ( 14.3 )	194471.6 ( 175.9 )	308618.7 ( 20.3 )	38260.0 ( 25.9 )	336943.2 ( 18.1 )	2891.8 ( 99999 )	3400.8 ( 99999 )	8460.4 ( 75.6 )	3561.3 ( 114.7 )	1334.9 ( 28.9 )	1852.9 ( 111.7 )	3686.0 ( 48.1 )
Cycle 2 - Day 3	88888 ( 88888 )	88888 ( 88888 )	9543.7 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	1572.1 ( 88.4 )	3103.8 ( 99.1 )	4385.7 ( 36.1 )	88888 ( 88888 )	3582.3 ( 88.2 )	2813.0 ( 19.2 )	8822.0 ( 119.1 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	310130.1 ( 24.6 )	88888 ( 88888 )	88888 ( 88888 )	339289.0 ( 37.0 )	296836.3 ( 1.0 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Up to end of study (Up to 363 weeks)

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

Part A: 100mg, 2/wk

Reporting group description

Reporting group title

Part A: (10mg-M/20mg-M) 50mg, 4d on/3d off

Reporting group description

Reporting group title

Part A: 100mg, 3/wk

Reporting group description

Reporting group title

Part A: 100mg, 3d on/4d off

Reporting group description

Reporting group title

Part A: 100mg, daily

Reporting group description

Reporting group title

Part A: 25mg BD, daily

Reporting group description

Reporting group title

Part A: 25mg, daily

Reporting group description

Reporting group title

Part A: 30mg-M, 4d on/3d off

Reporting group description

Reporting group title

Part A: 50mg BD, 3d on/4d off

Reporting group description

Reporting group title

Part A: 35mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part A: 35mg BD-M, 10d on/4d off

Reporting group description

Reporting group title

Part A: 50mg, 4d on/3d off

Reporting group description

Reporting group title

Part A: 50mg OD-M, 10d on/4d off

Reporting group description

Reporting group title

Part A: 50mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part A: 50mg, 5d on/2d off

Reporting group description

Reporting group title

Part A: 50mg-M, 4d on/3d off

Reporting group description

Reporting group title

Part A: 50mg, daily

Reporting group description

Reporting group title

Part A: 75mg-M, 4d on/3d off

Reporting group description

Reporting group title

Part D1: 100mg-M, 4d on/3d off

Reporting group description

Reporting group title

Part C1: 50mg-M, 4d on/3d off

Reporting group description

Reporting group title

Part C1: 35mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part B1: 35mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part D1: 35mg BD 75mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part D1: 50mg OD-M, 10d on/4d off

Reporting group description

Reporting group title

Part D1: 50mg-M, 4d on/3d off

Reporting group description

Reporting group title

Part D1: 75mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part D1: 75mg-M, 4d on/3d off

Reporting group description

Reporting group title

Part D1: 75mg-M, daily

Reporting group description

Reporting group title

Part E1: 35mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part E1: 50mg, 4d on/3d off

Reporting group description

Reporting group title

Part E1: 50mg-M, 4d on/3d off

Reporting group description

Reporting group title

Part F1: 35mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part F1: 25mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part E2: 35mg BD-M, 4d on/3d off

Reporting group description

Reporting group title

Part E1: 75mg-M, 4d on/3d off

Reporting group description

Reporting group title

Part H1: 25mg BD-M, 4d on/3d off

Reporting group description

Part A: 100mg, 2/wk

Part A: (10mg-M/20mg-M) 50mg, 4d on/3d off

Part A: 100mg, 3/wk

Part A: 100mg, 3d on/4d off

Part A: 100mg, daily

Part A: 25mg BD, daily

Part A: 25mg, daily

Part A: 30mg-M, 4d on/3d off

Part A: 50mg BD, 3d on/4d off

Part A: 35mg BD-M, 4d on/3d off

Part A: 35mg BD-M, 10d on/4d off

Part A: 50mg, 4d on/3d off

Part A: 50mg OD-M, 10d on/4d off

Part A: 50mg BD-M, 4d on/3d off

Part A: 50mg, 5d on/2d off

Part A: 50mg-M, 4d on/3d off

Part A: 50mg, daily

Part A: 75mg-M, 4d on/3d off

Part D1: 100mg-M, 4d on/3d off

Part C1: 50mg-M, 4d on/3d off

Part C1: 35mg BD-M, 4d on/3d off

Part B1: 35mg BD-M, 4d on/3d off

Part D1: 35mg BD 75mg BD-M, 4d on/3d off

Part D1: 50mg OD-M, 10d on/4d off

Part D1: 50mg-M, 4d on/3d off

Part D1: 75mg BD-M, 4d on/3d off

Part D1: 75mg-M, 4d on/3d off

Part D1: 75mg-M, daily

Part E1: 35mg BD-M, 4d on/3d off

Part E1: 50mg, 4d on/3d off

Part E1: 50mg-M, 4d on/3d off

Part F1: 35mg BD-M, 4d on/3d off

Part F1: 25mg BD-M, 4d on/3d off

Part E2: 35mg BD-M, 4d on/3d off

Part E1: 75mg-M, 4d on/3d off

Part H1: 25mg BD-M, 4d on/3d off

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 4 (25.00%)

3 / 5 (60.00%)

3 / 4 (75.00%)

5 / 8 (62.50%)

4 / 4 (100.00%)

1 / 6 (16.67%)

0 / 5 (0.00%)

4 / 8 (50.00%)

2 / 8 (25.00%)

1 / 2 (50.00%)

1 / 6 (16.67%)

1 / 2 (50.00%)

2 / 4 (50.00%)

3 / 7 (42.86%)

4 / 8 (50.00%)

4 / 5 (80.00%)

0 / 2 (0.00%)

5 / 8 (62.50%)

3 / 7 (42.86%)

4 / 15 (26.67%)

1 / 5 (20.00%)

0 / 4 (0.00%)

1 / 7 (14.29%)

1 / 6 (16.67%)

1 / 9 (11.11%)

2 / 3 (66.67%)

7 / 16 (43.75%)

0 / 1 (0.00%)

1 / 4 (25.00%)

10 / 20 (50.00%)

1 / 6 (16.67%)

5 / 7 (71.43%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

Brain neoplasm

Additional description: Brain neoplasm

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

1 / 7 (14.29%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hormone-refractory prostate cancer

Additional description: Hormone-refractory prostate cancer

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

1 / 8 (12.50%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

Tumour haemorrhage

Additional description: Tumour haemorrhage

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (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

Vascular disorders

Deep vein thrombosis

Additional description: Deep vein thrombosis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Flushing

Additional description: Flushing

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypertension

Additional description: Hypertension

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Orthostatic hypotension

Additional description: Orthostatic hypotension

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

1 / 7 (14.29%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

Fatigue

Additional description: Fatigue

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

1 / 2 (50.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Multiple organ dysfunction syndrome

Additional description: Multiple organ dysfunction syndrome

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain

Additional description: Pain

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyrexia

Additional description: Pyrexia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

1 / 6 (16.67%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

1 / 5 (20.00%)

0 / 2 (0.00%)

1 / 8 (12.50%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

1 / 16 (6.25%)

0 / 1 (0.00%)

1 / 4 (25.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

Pelvic pain

Additional description: Pelvic pain

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

1 / 2 (50.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

1 / 7 (14.29%)

1 / 15 (6.67%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

Additional description: Chronic obstructive pulmonary disease

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Dyspnoea

Additional description: Dyspnoea

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

1 / 8 (12.50%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Epistaxis

Additional description: Epistaxis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemoptysis

Additional description: Haemoptysis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pleural effusion

Additional description: Pleural effusion

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonitis

Additional description: Pneumonitis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Pneumothorax

Additional description: Pneumothorax

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary embolism

Additional description: Pulmonary embolism

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

1 / 7 (14.29%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Confusional state

Additional description: Confusional state

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

1 / 2 (50.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (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

Delirium

Additional description: Delirium

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

1 / 8 (12.50%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

Blood creatinine increased

Additional description: Blood creatinine increased

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

C-reactive protein increased

Additional description: C-reactive protein increased

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

Femoral neck fracture

Additional description: Femoral neck fracture

subjects affected / exposed

0 / 4 (0.00%)

1 / 5 (20.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

1 / 4 (25.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

Overdose

Additional description: Overdose

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pelvic fracture

Additional description: Pelvic fracture

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Rib fracture

Additional description: Rib fracture

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Transfusion-associated dyspnoea

Additional description: Transfusion-associated dyspnoea

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

1 / 8 (12.50%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Acute myocardial infarction

Additional description: Acute myocardial infarction

subjects affected / exposed

1 / 4 (25.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

1 / 7 (14.29%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial flutter

Additional description: Atrial flutter

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocardial infarction

Additional description: Myocardial infarction

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tachycardia

Additional description: Tachycardia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Cerebrovascular accident

Additional description: Cerebrovascular accident

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dizziness

Additional description: Dizziness

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Hemiparesis

Additional description: Hemiparesis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

1 / 16 (6.25%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Malignant spinal cord compression

Additional description: Malignant spinal cord compression

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

1 / 15 (6.67%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

Additional description: Anaemia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

1 / 2 (50.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Disseminated intravascular coagulation

Additional description: Disseminated intravascular coagulation

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

1 / 15 (6.67%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Febrile neutropenia

Additional description: Febrile neutropenia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Heparin-induced thrombocytopenia

Additional description: Heparin-induced thrombocytopenia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

1 / 8 (12.50%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Thrombocytopenia

Additional description: Thrombocytopenia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

1 / 8 (12.50%)

1 / 4 (25.00%)

1 / 6 (16.67%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal pain

Additional description: Abdominal pain

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

1 / 4 (25.00%)

1 / 8 (12.50%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

1 / 16 (6.25%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Constipation

Additional description: Constipation

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

1 / 2 (50.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea

Additional description: Diarrhoea

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

1 / 16 (6.25%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal haemorrhage

Additional description: Gastrointestinal haemorrhage

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Large intestinal obstruction

Additional description: Large intestinal obstruction

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

1 / 15 (6.67%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (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

Large intestine perforation

Additional description: Large intestine perforation

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Nausea

Additional description: Nausea

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

1 / 8 (12.50%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

1 / 3 (33.33%)

1 / 16 (6.25%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

0 / 1

1 / 1

0 / 0

0 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Stomatitis

Additional description: Stomatitis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

Additional description: Vomiting

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

1 / 8 (12.50%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

1 / 16 (6.25%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Hepatic haemorrhage

Additional description: Hepatic haemorrhage

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

1 / 8 (12.50%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyperbilirubinaemia

Additional description: Hyperbilirubinaemia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Acute kidney injury

Additional description: Acute kidney injury

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

2 / 8 (25.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

1 / 2 (50.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

1 / 5 (20.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematuria

Additional description: Haematuria

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

1 / 4 (25.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

Hydronephrosis

Additional description: Hydronephrosis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

1 / 16 (6.25%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal impairment

Additional description: Renal impairment

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

1 / 15 (6.67%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary retention

Additional description: Urinary retention

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

1 / 4 (25.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

Urinary tract obstruction

Additional description: Urinary tract obstruction

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (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

Arthralgia

Additional description: Arthralgia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Back pain

Additional description: Back pain

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

1 / 15 (6.67%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 9 (11.11%)

2 / 3 (66.67%)

1 / 16 (6.25%)

0 / 1 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bone pain

Additional description: Bone pain

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

1 / 6 (16.67%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain in extremity

Additional description: Pain in extremity

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

COVID-19

Additional description: COVID-19

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diverticulitis

Additional description: Diverticulitis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

1 / 15 (6.67%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Escherichia urinary tract infection

Additional description: Escherichia urinary tract infection

subjects affected / exposed

0 / 4 (0.00%)

1 / 5 (20.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Groin abscess

Additional description: Groin abscess

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

1 / 4 (25.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infection

Additional description: Infection

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

2 / 8 (25.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 6 (16.67%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Influenza

Additional description: Influenza

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower respiratory tract infection

Additional description: Lower respiratory tract infection

subjects affected / exposed

0 / 4 (0.00%)

2 / 5 (40.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

2 / 5 (40.00%)

0 / 2 (0.00%)

1 / 8 (12.50%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

2 / 7 (28.57%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

Pneumonia

Additional description: Pneumonia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 6 (16.67%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Pneumonia aspiration

Additional description: Pneumonia aspiration

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary sepsis

Additional description: Pulmonary sepsis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

1 / 7 (14.29%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyelonephritis

Additional description: Pyelonephritis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

1 / 16 (6.25%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Staphylococcal bacteraemia

Additional description: Staphylococcal bacteraemia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

1 / 5 (20.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Sepsis

Additional description: Sepsis

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

1 / 4 (25.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

1 / 8 (12.50%)

0 / 7 (0.00%)

1 / 15 (6.67%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

1 / 16 (6.25%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Upper respiratory tract infection

Additional description: Upper respiratory tract infection

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 7 (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

Urinary tract infection

Additional description: Urinary tract infection

subjects affected / exposed

0 / 4 (0.00%)

2 / 5 (40.00%)

0 / 4 (0.00%)

1 / 8 (12.50%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

1 / 6 (16.67%)

0 / 2 (0.00%)

1 / 2 (50.00%)

1 / 4 (25.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

1 / 5 (20.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urosepsis

Additional description: Urosepsis

subjects affected / exposed

0 / 4 (0.00%)

1 / 5 (20.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

1 / 6 (16.67%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Decreased appetite

Additional description: Decreased appetite

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Dehydration

Additional description: Dehydration

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

1 / 15 (6.67%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Hyperglycaemia

Additional description: Hyperglycaemia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

1 / 5 (20.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

1 / 16 (6.25%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (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

Hyperkalaemia

Additional description: Hyperkalaemia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypokalaemia

Additional description: Hypokalaemia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 8 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyponatraemia

Additional description: Hyponatraemia

subjects affected / exposed

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

1 / 8 (12.50%)

2 / 4 (50.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 8 (12.50%)

0 / 8 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 8 (0.00%)

0 / 7 (0.00%)

0 / 15 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 9 (0.00%)

0 / 3 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 4 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

2 / 2

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Part A: 100mg, 2/wk	Part A: (10mg-M/20mg-M) 50mg, 4d on/3d off	Part A: 100mg, 3/wk	Part A: 100mg, 3d on/4d off	Part A: 100mg, daily	Part A: 25mg BD, daily	Part A: 25mg, daily	Part A: 30mg-M, 4d on/3d off	Part A: 50mg BD, 3d on/4d off	Part A: 35mg BD-M, 4d on/3d off	Part A: 35mg BD-M, 10d on/4d off	Part A: 50mg, 4d on/3d off	Part A: 50mg OD-M, 10d on/4d off	Part A: 50mg BD-M, 4d on/3d off	Part A: 50mg, 5d on/2d off	Part A: 50mg-M, 4d on/3d off	Part A: 50mg, daily	Part A: 75mg-M, 4d on/3d off	Part D1: 100mg-M, 4d on/3d off	Part C1: 50mg-M, 4d on/3d off	Part C1: 35mg BD-M, 4d on/3d off	Part B1: 35mg BD-M, 4d on/3d off	Part D1: 35mg BD 75mg BD-M, 4d on/3d off	Part D1: 50mg OD-M, 10d on/4d off	Part D1: 50mg-M, 4d on/3d off	Part D1: 75mg BD-M, 4d on/3d off	Part D1: 75mg-M, 4d on/3d off	Part D1: 75mg-M, daily	Part E1: 35mg BD-M, 4d on/3d off	Part E1: 50mg, 4d on/3d off	Part E1: 50mg-M, 4d on/3d off	Part F1: 35mg BD-M, 4d on/3d off	Part F1: 25mg BD-M, 4d on/3d off	Part E2: 35mg BD-M, 4d on/3d off	Part E1: 75mg-M, 4d on/3d off	Part H1: 25mg BD-M, 4d on/3d off
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 4 (75.00%)	5 / 5 (100.00%)	4 / 4 (100.00%)	8 / 8 (100.00%)	4 / 4 (100.00%)	6 / 6 (100.00%)	6 / 6 (100.00%)	5 / 5 (100.00%)	8 / 8 (100.00%)	8 / 8 (100.00%)	2 / 2 (100.00%)	6 / 6 (100.00%)	2 / 2 (100.00%)	2 / 2 (100.00%)	4 / 4 (100.00%)	7 / 7 (100.00%)	7 / 8 (87.50%)	5 / 5 (100.00%)	2 / 2 (100.00%)	8 / 8 (100.00%)	7 / 7 (100.00%)	15 / 15 (100.00%)	5 / 5 (100.00%)	4 / 4 (100.00%)	7 / 7 (100.00%)	5 / 6 (83.33%)	8 / 9 (88.89%)	3 / 3 (100.00%)	15 / 16 (93.75%)	1 / 1 (100.00%)	1 / 1 (100.00%)	4 / 4 (100.00%)	4 / 4 (100.00%)	20 / 20 (100.00%)	6 / 6 (100.00%)	7 / 7 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
Additional description: Melanocytic naevus
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Tumour pain
Additional description: Tumour pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vascular disorders
Flushing
Additional description: Flushing
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0
Haematoma
Additional description: Haematoma
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hot flush
Additional description: Hot flush
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Hypertension
Additional description: Hypertension
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 9 (22.22%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	1	0	0	0	2	0	0	0	1	0	1	0	0	0
Hypotension
Additional description: Hypotension
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	2 / 8 (25.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	1	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0	1	0	0	3	0	0	0	0	0	0	0	0	0	0	1	0	1
Lymphoedema
Additional description: Lymphoedema
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	2 / 6 (33.33%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Orthostatic hypotension
Additional description: Orthostatic hypotension
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Peripheral coldness
Additional description: Peripheral coldness
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Varicose vein
Additional description: Varicose vein
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
White coat hypertension
Additional description: White coat hypertension
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Asthenia
Additional description: Asthenia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	2 / 16 (12.50%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	8 / 20 (40.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	2	0	0	0	0	9	0	0
Catheter site erythema
Additional description: Catheter site erythema
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Catheter site irritation
Additional description: Catheter site irritation
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Catheter site pain
Additional description: Catheter site pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Catheter site rash
Additional description: Catheter site rash
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Catheter site related reaction
Additional description: Catheter site related reaction
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Chest discomfort
Additional description: Chest discomfort
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Chest pain
Additional description: Chest pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	2 / 6 (33.33%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	1 / 5 (20.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	1	0	1	0	0	0	1	0	0	0	1	2	0	0
Chills
Additional description: Chills
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	1	1	0	1
Crepitations
Additional description: Crepitations
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Device related thrombosis
Additional description: Device related thrombosis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Early satiety
Additional description: Early satiety
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Feeling abnormal
Additional description: Feeling abnormal
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Fatigue
Additional description: Fatigue
subjects affected / exposed	1 / 4 (25.00%)	4 / 5 (80.00%)	3 / 4 (75.00%)	3 / 8 (37.50%)	1 / 4 (25.00%)	2 / 6 (33.33%)	2 / 6 (33.33%)	4 / 5 (80.00%)	3 / 8 (37.50%)	4 / 8 (50.00%)	2 / 2 (100.00%)	2 / 6 (33.33%)	1 / 2 (50.00%)	0 / 2 (0.00%)	2 / 4 (50.00%)	5 / 7 (71.43%)	4 / 8 (50.00%)	4 / 5 (80.00%)	1 / 2 (50.00%)	4 / 8 (50.00%)	6 / 7 (85.71%)	7 / 15 (46.67%)	5 / 5 (100.00%)	3 / 4 (75.00%)	3 / 7 (42.86%)	3 / 6 (50.00%)	5 / 9 (55.56%)	3 / 3 (100.00%)	4 / 16 (25.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	3 / 4 (75.00%)	3 / 4 (75.00%)	5 / 20 (25.00%)	3 / 6 (50.00%)	5 / 7 (71.43%)
occurrences all number	1	4	3	3	1	2	2	5	3	5	2	2	1	0	2	5	4	5	2	4	7	12	7	3	3	3	5	3	4	1	2	3	3	5	3	5
Feeling hot
Additional description: Feeling hot
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Feeling jittery
Additional description: Feeling jittery
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Gait disturbance
Additional description: Gait disturbance
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
General physical health deterioration
Additional description: General physical health deterioration
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Hernia pain
Additional description: Hernia pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Influenza like illness
Additional description: Influenza like illness
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Mucosal inflammation
Additional description: Mucosal inflammation
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0
Non-cardiac chest pain
Additional description: Non-cardiac chest pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Oedema peripheral
Additional description: Oedema peripheral
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	1	0	0	1	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	2	0
Pain
Additional description: Pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1	0	0	1	0	0	0	0	0	2	1	0
Peripheral swelling
Additional description: Peripheral swelling
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Pyrexia
Additional description: Pyrexia
subjects affected / exposed	1 / 4 (25.00%)	2 / 5 (40.00%)	1 / 4 (25.00%)	1 / 8 (12.50%)	1 / 4 (25.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	1 / 5 (20.00%)	1 / 8 (12.50%)	1 / 8 (12.50%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 2 (0.00%)	2 / 4 (50.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	2 / 8 (25.00%)	1 / 7 (14.29%)	2 / 15 (13.33%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	3 / 7 (42.86%)
occurrences all number	1	2	1	1	2	0	1	1	3	1	0	1	0	0	2	1	0	1	0	3	1	2	0	1	0	0	0	0	0	0	0	0	0	1	0	6
Swelling face
Additional description: Swelling face
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Thirst
Additional description: Thirst
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 4 (50.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	1	0
Vaccination site reaction
Additional description: Vaccination site reaction
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Immune system disorders
Seasonal allergy
Additional description: Seasonal allergy
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Reproductive system and breast disorders
Genital lesion
Additional description: Genital lesion
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nipple pain
Additional description: Nipple pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Oedema genital
Additional description: Oedema genital
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pelvic discomfort
Additional description: Pelvic discomfort
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Penile discharge
Additional description: Penile discharge
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Pelvic pain
Additional description: Pelvic pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Penile haemorrhage
Additional description: Penile haemorrhage
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Penile pain
Additional description: Penile pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Penile oedema
Additional description: Penile oedema
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Scrotal oedema
Additional description: Scrotal oedema
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vaginal discharge
Additional description: Vaginal discharge
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0
Vaginal haemorrhage
Additional description: Vaginal haemorrhage
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2
Respiratory, thoracic and mediastinal disorders
Bronchospasm
Additional description: Bronchospasm
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Chronic obstructive pulmonary disease
Additional description: Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Cough
Additional description: Cough
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	1 / 6 (16.67%)	1 / 6 (16.67%)	2 / 5 (40.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	2 / 16 (12.50%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	2 / 7 (28.57%)
occurrences all number	0	0	0	1	0	1	1	2	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	2	0	0	1	1	2	0	2
Dry throat
Additional description: Dry throat
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dysphonia
Additional description: Dysphonia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Dyspnoea
Additional description: Dyspnoea
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	1 / 8 (12.50%)	1 / 8 (12.50%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	2 / 7 (28.57%)	1 / 8 (12.50%)	1 / 5 (20.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	1 / 7 (14.29%)	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	4 / 16 (25.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	3 / 20 (15.00%)	0 / 6 (0.00%)	3 / 7 (42.86%)
occurrences all number	0	0	0	1	1	0	0	1	1	1	1	0	0	0	1	2	1	1	0	1	1	3	0	0	1	0	0	0	4	1	0	0	1	4	0	3
Dyspnoea exertional
Additional description: Dyspnoea exertional
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Epistaxis
Additional description: Epistaxis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	2	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	1	0	0
Haemoptysis
Additional description: Haemoptysis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hiccups
Additional description: Hiccups
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Increased bronchial secretion
Additional description: Increased bronchial secretion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 8 (25.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Increased upper airway secretion
Additional description: Increased upper airway secretion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nasal dryness
Additional description: Nasal dryness
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Oropharyngeal pain
Additional description: Oropharyngeal pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	1 / 5 (20.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Pleural effusion
Additional description: Pleural effusion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	2 / 8 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pleuritic pain
Additional description: Pleuritic pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Pneumothorax
Additional description: Pneumothorax
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0
Pulmonary embolism
Additional description: Pulmonary embolism
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Pulmonary oedema
Additional description: Pulmonary oedema
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory failure
Additional description: Respiratory failure
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Respiratory tract inflammation
Additional description: Respiratory tract inflammation
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Rhinorrhoea
Additional description: Rhinorrhoea
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	2 / 7 (28.57%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Tachypnoea
Additional description: Tachypnoea
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Wheezing
Additional description: Wheezing
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Psychiatric disorders
Agitation
Additional description: Agitation
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Anxiety
Additional description: Anxiety
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0
Confusional state
Additional description: Confusional state
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Delirium
Additional description: Delirium
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Depressed mood
Additional description: Depressed mood
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	2 / 7 (28.57%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	2 / 5 (40.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	1	0	0	0	0	0	0	2	0	0	0	0	0	0	2	0	0	0	1	0	0	0	1	0	0	0	0	0
Depression
Additional description: Depression
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	1	0
Disorientation
Additional description: Disorientation
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hallucination
Additional description: Hallucination
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Insomnia
Additional description: Insomnia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	3 / 7 (42.86%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	1	0	1	0	0	1	0	1	0	0	0	0	0	0	0	0	4
Irritability
Additional description: Irritability
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0
Mood swings
Additional description: Mood swings
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Personality change
Additional description: Personality change
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Restlessness
Additional description: Restlessness
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 8 (25.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Product issues
Device occlusion
Additional description: Device occlusion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Investigations
Activated partial thromboplastin time prolonged
Additional description: Activated partial thromboplastin time prolonged
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	1	0	0	0	0	0	0	0
Alanine aminotransferase increased
Additional description: Alanine aminotransferase increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	2 / 16 (12.50%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	4	0	1	0	0	1	0	0
Amylase increased
Additional description: Amylase increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Aspartate aminotransferase increased
Additional description: Aspartate aminotransferase increased
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	1 / 7 (14.29%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	3 / 16 (18.75%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	1	0	0	0	0	0	1	0	0	0	1	0	0	0	1	5	0	0	0	1	1	2	0	0	0	0	0	0	4	0	1	0	0	2	0	1
Blood alkaline phosphatase increased
Additional description: Blood alkaline phosphatase increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	2 / 16 (12.50%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	1	0	2	0	0	0	0	1	0	1
Blood bilirubin increased
Additional description: Blood bilirubin increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	2	0	0	1	0	0	0	0	1	0	0
Blood creatinine increased
Additional description: Blood creatinine increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	3 / 4 (75.00%)	3 / 8 (37.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	1 / 8 (12.50%)	1 / 8 (12.50%)	1 / 2 (50.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	2 / 2 (100.00%)	2 / 4 (50.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	1 / 15 (6.67%)	3 / 5 (60.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 9 (11.11%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)
occurrences all number	0	0	3	3	0	0	0	1	1	1	2	1	0	4	2	0	0	1	0	1	0	1	4	0	0	1	1	0	1	0	0	1	0	2	1	2
Blood folate decreased
Additional description: Blood folate decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Blood lactate dehydrogenase increased
Additional description: Blood lactate dehydrogenase increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	2 / 16 (12.50%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	2	0	0	0	0	0	0	0
C-reactive protein increased
Additional description: C-reactive protein increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	1 / 15 (6.67%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	1	0	0	1	0	2	1	0	0	0	0	0	1	0	0	0	1	0	0	1
Cardiac murmur
Additional description: Cardiac murmur
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Electrocardiogram QT prolonged
Additional description: Electrocardiogram QT prolonged
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	1	0	0
Electrocardiogram T wave inversion
Additional description: Electrocardiogram T wave inversion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Gamma-glutamyltransferase increased
Additional description: Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0
International normalised ratio increased
Additional description: International normalised ratio increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Lipase increased
Additional description: Lipase increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Prothrombin time prolonged
Additional description: Prothrombin time prolonged
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Troponin increased
Additional description: Troponin increased
subjects affected / exposed	2 / 4 (50.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Weight decreased
Additional description: Weight decreased
subjects affected / exposed	1 / 4 (25.00%)	1 / 5 (20.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	1 / 8 (12.50%)	2 / 8 (25.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	3 / 4 (75.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	3 / 7 (42.86%)	3 / 15 (20.00%)	2 / 5 (40.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	2 / 16 (12.50%)	0 / 1 (0.00%)	1 / 1 (100.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	2 / 6 (33.33%)	2 / 7 (28.57%)
occurrences all number	1	1	1	0	0	0	0	1	1	2	0	0	0	0	4	1	0	0	0	1	3	3	2	0	1	0	0	0	2	0	1	1	0	0	2	2
Injury, poisoning and procedural complications
Animal bite
Additional description: Animal bite
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Arthropod bite
Additional description: Arthropod bite
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Contusion
Additional description: Contusion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	3 / 8 (37.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	0	0	0	1	0	3	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	2
Fall
Additional description: Fall
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	2 / 15 (13.33%)	1 / 5 (20.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	1	0	0	0	0	0	2	0	0	0	1	0	0	0	1	0	0	4	2	1	0	1	0	1	0	0	0	0	0	0	0	0	3
Infusion related reaction
Additional description: Infusion related reaction
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nail avulsion
Additional description: Nail avulsion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Post procedural contusion
Additional description: Post procedural contusion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Procedural pain
Additional description: Procedural pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	1	0	0	1	0	0	0	0
Radiation skin injury
Additional description: Radiation skin injury
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1
Radius fracture
Additional description: Radius fracture
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Rib fracture
Additional description: Rib fracture
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Skin abrasion
Additional description: Skin abrasion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin laceration
Additional description: Skin laceration
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	1
Stoma site discharge
Additional description: Stoma site discharge
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Stoma site pain
Additional description: Stoma site pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Tooth fracture
Additional description: Tooth fracture
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Toxicity to various agents
Additional description: Toxicity to various agents
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Cardiac disorders
Atrial fibrillation
Additional description: Atrial fibrillation
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Bradycardia
Additional description: Bradycardia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Bundle branch block right
Additional description: Bundle branch block right
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Palpitations
Additional description: Palpitations
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	2	0	0
Sinus bradycardia
Additional description: Sinus bradycardia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	2 / 6 (33.33%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Sinus tachycardia
Additional description: Sinus tachycardia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0
Tachycardia
Additional description: Tachycardia
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0
Nervous system disorders
Ageusia
Additional description: Ageusia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Amnesia
Additional description: Amnesia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	1	0
Aphasia
Additional description: Aphasia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Ataxia
Additional description: Ataxia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Brain fog
Additional description: Brain fog
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Cervical cord compression
Additional description: Cervical cord compression
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Cognitive disorder
Additional description: Cognitive disorder
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Disturbance in attention
Additional description: Disturbance in attention
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Dizziness
Additional description: Dizziness
subjects affected / exposed	1 / 4 (25.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 8 (25.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	2 / 5 (40.00%)	0 / 2 (0.00%)	2 / 8 (25.00%)	2 / 7 (28.57%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	1 / 6 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	1	0	0	0	0	0	0	2	1	0	0	0	1	0	0	1	2	0	2	2	0	0	0	0	0	0	2	0	1	0	0	0	3	1	2
Dysgeusia
Additional description: Dysgeusia
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	1 / 4 (25.00%)	2 / 8 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	2 / 5 (40.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	1 / 15 (6.67%)	2 / 5 (40.00%)	2 / 4 (50.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	3 / 20 (15.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)
occurrences all number	0	1	1	2	0	0	0	2	0	0	0	0	0	1	1	1	0	0	0	0	1	1	2	2	0	0	0	0	1	0	0	1	0	3	1	1
Essential tremor
Additional description: Essential tremor
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Head discomfort
Additional description: Head discomfort
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Headache
Additional description: Headache
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	1 / 4 (25.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	1 / 5 (20.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	1 / 2 (50.00%)	1 / 8 (12.50%)	3 / 7 (42.86%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	5 / 20 (25.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	1	1	0	1	1	1	0	1	0	0	0	0	1	0	0	1	1	3	0	1	0	1	0	1	2	0	0	1	0	3	8	0	1
Hypoaesthesia
Additional description: Hypoaesthesia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lethargy
Additional description: Lethargy
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	1 / 8 (12.50%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	2 / 16 (12.50%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	1	0	0
Lumbar radiculopathy
Additional description: Lumbar radiculopathy
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Memory impairment
Additional description: Memory impairment
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	2	0	0
Neuropathy peripheral
Additional description: Neuropathy peripheral
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Neuralgia
Additional description: Neuralgia
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ophthalmic migraine
Additional description: Ophthalmic migraine
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Paraesthesia
Additional description: Paraesthesia
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	1	1	0	0	0	0	0	0	0	0
Parosmia
Additional description: Parosmia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Peripheral sensory neuropathy
Additional description: Peripheral sensory neuropathy
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Post herpetic neuralgia
Additional description: Post herpetic neuralgia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Presyncope
Additional description: Presyncope
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Restless legs syndrome
Additional description: Restless legs syndrome
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0
Sciatica
Additional description: Sciatica
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sensory loss
Additional description: Sensory loss
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Somnolence
Additional description: Somnolence
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0
Spinal cord compression
Additional description: Spinal cord compression
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Syncope
Additional description: Syncope
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Taste disorder
Additional description: Taste disorder
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Tremor
Additional description: Tremor
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	1	0	0	2	0	1
Trigeminal neuralgia
Additional description: Trigeminal neuralgia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Anaemia
Additional description: Anaemia
subjects affected / exposed	2 / 4 (50.00%)	1 / 5 (20.00%)	2 / 4 (50.00%)	6 / 8 (75.00%)	2 / 4 (50.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	1 / 5 (20.00%)	2 / 8 (25.00%)	4 / 8 (50.00%)	1 / 2 (50.00%)	2 / 6 (33.33%)	1 / 2 (50.00%)	1 / 2 (50.00%)	3 / 4 (75.00%)	1 / 7 (14.29%)	4 / 8 (50.00%)	2 / 5 (40.00%)	0 / 2 (0.00%)	2 / 8 (25.00%)	1 / 7 (14.29%)	4 / 15 (26.67%)	2 / 5 (40.00%)	2 / 4 (50.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	10 / 16 (62.50%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	6 / 20 (30.00%)	3 / 6 (50.00%)	4 / 7 (57.14%)
occurrences all number	2	1	2	6	2	1	0	1	2	5	1	2	1	2	3	1	4	2	0	2	2	4	2	2	0	0	0	0	10	0	0	1	0	8	4	8
Leukocytosis
Additional description: Leukocytosis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Leukopenia
Additional description: Leukopenia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Lymphadenopathy
Additional description: Lymphadenopathy
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lymphopenia
Additional description: Lymphopenia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Neutropenia
Additional description: Neutropenia
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	1	1	0	0	0	0	0	1	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Neutrophilia
Additional description: Neutrophilia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Thrombocytopenia
Additional description: Thrombocytopenia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	2 / 4 (50.00%)	1 / 8 (12.50%)	1 / 4 (25.00%)	2 / 6 (33.33%)	1 / 6 (16.67%)	0 / 5 (0.00%)	2 / 8 (25.00%)	6 / 8 (75.00%)	0 / 2 (0.00%)	2 / 6 (33.33%)	0 / 2 (0.00%)	1 / 2 (50.00%)	1 / 4 (25.00%)	2 / 7 (28.57%)	0 / 8 (0.00%)	2 / 5 (40.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	3 / 7 (42.86%)	3 / 15 (20.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 9 (11.11%)	0 / 3 (0.00%)	4 / 16 (25.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	1 / 6 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	2	1	1	2	3	0	3	7	0	2	0	2	2	2	0	2	0	0	3	3	1	0	0	1	1	0	4	0	3	0	0	2	1	2
Ear and labyrinth disorders
Deafness bilateral
Additional description: Deafness bilateral
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Deafness unilateral
Additional description: Deafness unilateral
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ear discomfort
Additional description: Ear discomfort
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ear pruritus
Additional description: Ear pruritus
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Hypoacusis
Additional description: Hypoacusis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Motion sickness
Additional description: Motion sickness
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Tinnitus
Additional description: Tinnitus
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0
Vertigo
Additional description: Vertigo
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0
Eye disorders
Blepharitis
Additional description: Blepharitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Cataract
Additional description: Cataract
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Conjunctival haemorrhage
Additional description: Conjunctival haemorrhage
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivitis allergic
Additional description: Conjunctivitis allergic
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dry eye
Additional description: Dry eye
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Eye swelling
Additional description: Eye swelling
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Glaucoma
Additional description: Glaucoma
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Vision blurred
Additional description: Vision blurred
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal discomfort
Additional description: Abdominal discomfort
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Abdominal distension
Additional description: Abdominal distension
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	1 / 4 (25.00%)	2 / 8 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	1	2	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Abdominal hernia
Additional description: Abdominal hernia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Abdominal pain
Additional description: Abdominal pain
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	1 / 4 (25.00%)	0 / 6 (0.00%)	3 / 6 (50.00%)	1 / 5 (20.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	1 / 15 (6.67%)	1 / 5 (20.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 3 (0.00%)	2 / 16 (12.50%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 4 (50.00%)	1 / 4 (25.00%)	3 / 20 (15.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)
occurrences all number	0	1	0	1	1	0	3	1	0	1	0	0	0	0	1	0	1	0	0	0	1	1	1	0	1	2	0	0	2	0	0	2	1	3	1	1
Abdominal pain lower
Additional description: Abdominal pain lower
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Abdominal pain upper
Additional description: Abdominal pain upper
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Anal incontinence
Additional description: Anal incontinence
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	2	0
Constipation
Additional description: Constipation
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	3 / 8 (37.50%)	4 / 4 (100.00%)	1 / 6 (16.67%)	1 / 6 (16.67%)	0 / 5 (0.00%)	2 / 8 (25.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 2 (0.00%)	0 / 2 (0.00%)	2 / 4 (50.00%)	4 / 7 (57.14%)	2 / 8 (25.00%)	2 / 5 (40.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	5 / 7 (71.43%)	6 / 15 (40.00%)	3 / 5 (60.00%)	1 / 4 (25.00%)	3 / 7 (42.86%)	0 / 6 (0.00%)	0 / 9 (0.00%)	2 / 3 (66.67%)	3 / 16 (18.75%)	1 / 1 (100.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	3 / 20 (15.00%)	1 / 6 (16.67%)	5 / 7 (71.43%)
occurrences all number	1	0	1	3	4	1	1	0	2	1	0	1	0	0	2	4	2	2	0	5	7	7	7	1	3	0	0	3	3	1	1	0	1	3	2	6
Diarrhoea
Additional description: Diarrhoea
subjects affected / exposed	0 / 4 (0.00%)	2 / 5 (40.00%)	1 / 4 (25.00%)	3 / 8 (37.50%)	1 / 4 (25.00%)	2 / 6 (33.33%)	1 / 6 (16.67%)	2 / 5 (40.00%)	1 / 8 (12.50%)	3 / 8 (37.50%)	1 / 2 (50.00%)	2 / 6 (33.33%)	0 / 2 (0.00%)	1 / 2 (50.00%)	1 / 4 (25.00%)	3 / 7 (42.86%)	1 / 8 (12.50%)	2 / 5 (40.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	2 / 7 (28.57%)	6 / 15 (40.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	4 / 7 (57.14%)	2 / 6 (33.33%)	0 / 9 (0.00%)	2 / 3 (66.67%)	5 / 16 (31.25%)	1 / 1 (100.00%)	1 / 1 (100.00%)	2 / 4 (50.00%)	1 / 4 (25.00%)	3 / 20 (15.00%)	2 / 6 (33.33%)	2 / 7 (28.57%)
occurrences all number	0	3	1	3	1	3	1	2	1	3	1	3	0	2	1	3	2	2	0	0	6	8	0	0	4	4	0	3	5	1	2	2	1	3	3	2
Dry mouth
Additional description: Dry mouth
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	1 / 6 (16.67%)	1 / 6 (16.67%)	1 / 5 (20.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	2 / 4 (50.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	1	2	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	2	1	0	0
Duodenal ulcer
Additional description: Duodenal ulcer
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dyschezia
Additional description: Dyschezia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dyspepsia
Additional description: Dyspepsia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	1 / 5 (20.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	3 / 16 (18.75%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	1	1	1	0	1	0	0	1	1	0	0	0	3	0	0	0	1	0	0	2
Dysphagia
Additional description: Dysphagia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0
Erosive duodenitis
Additional description: Erosive duodenitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Erosive oesophagitis
Additional description: Erosive oesophagitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Eructation
Additional description: Eructation
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Faeces soft
Additional description: Faeces soft
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Flatulence
Additional description: Flatulence
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Frequent bowel movements
Additional description: Frequent bowel movements
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0
Gastritis
Additional description: Gastritis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0
Gastrooesophageal reflux disease
Additional description: Gastrooesophageal reflux disease
subjects affected / exposed	1 / 4 (25.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	2 / 6 (33.33%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	1	0	0	0	1	0	0	1	0	2	0	0	1	0	0	0	0	1	1	0
Inguinal hernia
Additional description: Inguinal hernia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Lip pain
Additional description: Lip pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Lower gastrointestinal haemorrhage
Additional description: Lower gastrointestinal haemorrhage
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Mechanical ileus
Additional description: Mechanical ileus
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Mouth haemorrhage
Additional description: Mouth haemorrhage
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Nausea
Additional description: Nausea
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	4 / 8 (50.00%)	3 / 4 (75.00%)	2 / 6 (33.33%)	2 / 6 (33.33%)	4 / 5 (80.00%)	6 / 8 (75.00%)	0 / 8 (0.00%)	1 / 2 (50.00%)	2 / 6 (33.33%)	1 / 2 (50.00%)	1 / 2 (50.00%)	1 / 4 (25.00%)	3 / 7 (42.86%)	4 / 8 (50.00%)	2 / 5 (40.00%)	0 / 2 (0.00%)	2 / 8 (25.00%)	4 / 7 (57.14%)	3 / 15 (20.00%)	2 / 5 (40.00%)	4 / 4 (100.00%)	3 / 7 (42.86%)	2 / 6 (33.33%)	3 / 9 (33.33%)	1 / 3 (33.33%)	5 / 16 (31.25%)	0 / 1 (0.00%)	1 / 1 (100.00%)	2 / 4 (50.00%)	1 / 4 (25.00%)	3 / 20 (15.00%)	3 / 6 (50.00%)	5 / 7 (71.43%)
occurrences all number	0	0	0	5	3	2	2	5	6	0	2	2	1	2	1	3	4	2	0	2	6	6	3	5	3	2	3	1	6	0	1	5	3	3	3	6
Oral pain
Additional description: Oral pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	1
Paraesthesia oral
Additional description: Paraesthesia oral
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Proctalgia
Additional description: Proctalgia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Rectal discharge
Additional description: Rectal discharge
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Rectal haemorrhage
Additional description: Rectal haemorrhage
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Retching
Additional description: Retching
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Salivary hypersecretion
Additional description: Salivary hypersecretion
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Stomatitis
Additional description: Stomatitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Toothache
Additional description: Toothache
subjects affected / exposed	0 / 4 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Vomiting
Additional description: Vomiting
subjects affected / exposed	0 / 4 (0.00%)	2 / 5 (40.00%)	1 / 4 (25.00%)	2 / 8 (25.00%)	2 / 4 (50.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	3 / 8 (37.50%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	2 / 4 (50.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 5 (0.00%)	0 / 2 (0.00%)	2 / 8 (25.00%)	1 / 7 (14.29%)	3 / 15 (20.00%)	2 / 5 (40.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 3 (33.33%)	6 / 16 (37.50%)	0 / 1 (0.00%)	1 / 1 (100.00%)	1 / 4 (25.00%)	2 / 4 (50.00%)	2 / 20 (10.00%)	1 / 6 (16.67%)	4 / 7 (57.14%)
occurrences all number	0	2	1	2	2	0	0	1	3	0	0	0	0	1	2	0	1	0	0	2	1	3	2	1	1	0	1	1	7	0	2	1	4	2	1	5
Hepatobiliary disorders
Biliary colic
Additional description: Biliary colic
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Biliary tract disorder
Additional description: Biliary tract disorder
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Hepatic pain
Additional description: Hepatic pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Hyperbilirubinaemia
Additional description: Hyperbilirubinaemia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 3 (33.33%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Hypertransaminasaemia
Additional description: Hypertransaminasaemia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Actinic keratosis
Additional description: Actinic keratosis
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Alopecia
Additional description: Alopecia
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0
Blood blister
Additional description: Blood blister
subjects affected / exposed	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 15 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 3 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

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Clinical trials

Clinical Trial Results: An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination in patients with advanced solid/metastatic tumours

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Withdrawal

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Withdrawal

Primary: Number of Participants With Worst Shift in Laboratory Data-Hematology According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades

Primary: Number of Participants With Worst Shift in Laboratory Data-Hematology According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades

Primary: Number of Participants With Worst Shift in Laboratory Data-Biochemistry According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades

Primary: Number of Participants With Worst Shift in Laboratory Data-Biochemistry According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades

Primary: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters - Urinalysis

Primary: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters - Urinalysis

Primary: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Primary: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Primary: Number of Participants With Worst Shift in QTcF According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades

Primary: Number of Participants With Worst Shift in QTcF According to Common Terminology Criteria for Adverse Events (CTCAE)-Version 5 Grades

Secondary: Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Response in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Secondary: Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Response in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Secondary: Number of Participants With CTC Response

Secondary: Number of Participants With CTC Response

Secondary: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Secondary: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Secondary: Radiological Progression Free Survival (rPFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Secondary: Radiological Progression Free Survival (rPFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Secondary: Overall Survival (OS)

Secondary: Overall Survival (OS)

Secondary: Maximum Observed Plasma Concentration (Cmax)

Secondary: Maximum Observed Plasma Concentration (Cmax)

Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-24)

Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-24)

Adverse events

Clinical Trial Results:
An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination in patients with advanced solid/metastatic tumours