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Clinical Trial Results:
A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies

Summary
EudraCT number	2018-003172-12
Trial protocol	GB IT HU PL
Global end of trial date	03 Oct 2024

Results information
Results version number	v1(current)
This version publication date	30 Mar 2025
First version publication date	30 Mar 2025
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

KY1044-CT01

ISRCTN number

US NCT number

NCT03829501

WHO universal trial number (UTN)

U1111-1269-6777

Other trial identifiers

Sanofi Study ID: TCD17370

Sponsor organisation name

Kymab Ltd, a Sanofi company

Sponsor organisation address

The Eddeva Building (B920) Babraham Research Campus, Cambridge, United Kingdom, CB22 3AT

Public contact

Trial Transparency, Kymab Ltd, a Sanofi company, contact-US@sanofi.com

Scientific contact

Trial Transparency, Kymab Ltd, a Sanofi company, contact-US@sanofi.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

03 Oct 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

03 Oct 2024

Was the trial ended prematurely?

Yes

Main objective of the trial

The main objective of Phase 1 was to characterize the safety and tolerability of KY1044 as single agent and in combination with atezolizumab and to identify recommended doses for future studies. The main objective of Phase 2 was to estimate the anti-tumor efficacy of KY1044 as single agent and in combination with atezolizumab.

Protection of trial subjects

Participants were fully informed of all pertinent aspects of clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the participant and considering the local culture. During the course of the trial, participants were provided with individual participant cards indicating the nature of the trial the participant is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Jan 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 46

Country: Number of subjects enrolled

United States: 93

Country: Number of subjects enrolled

Hungary: 3

Country: Number of subjects enrolled

Italy: 55

Country: Number of subjects enrolled

Taiwan: 25

Worldwide total number of subjects

222

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)

133

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

The study was conducted at 22 centers in 6 countries.

Screening details

A total of 222 participants, of which 0 were screen failures. Participants were enrolled from 28 January 2019 to 04 August 2023.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Alomfilimab 0.8 mg

Arm description

Participants received alomfilimab 0.8 mg as a single agent via intravenous (IV) infusion every 3 weeks (Q3W). The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed disease progression (PD) per immune-related (i) Response Evaluation Criteria in Solid Tumors (RECIST).

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Alomfilimab 2.4 mg

Arm description

Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Alomfilimab 8 mg

Arm description

Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. One participant was planned to receive alomfilimab 8 mg + atezolizumab; however, the actual dose received was alomfilimab 8 mg. For the Safety Analysis Set, this participant was counted under actual dose received (alomfilimab 8 mg).

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Alomfilimab 24 mg

Arm description

Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Alomfilimab 80 mg

Arm description

Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Alomfilimab 240 mg

Arm description

Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Alomfilimab 0.8 mg + Atezolizumab

Arm description

Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 2.4 mg + Atezolizumab

Arm description

Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 8 mg + Atezolizumab

Arm description

Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST. One participant was planned to receive alomfilimab 8 mg + atezolizumab; however, the actual dose received was alomfilimab 8 mg. For the Safety Analysis Set, this participant was counted under actual dose received (alomfilimab 8 mg).

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 24 mg + Atezolizumab

Arm description

Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Alomfilimab 80 mg + Atezolizumab

Arm description

Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Arm description

Anti-PD-(L)1 naïve participants with pancreatic cancer (PC) received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Arm description

Anti-PD-(L)1 naïve participants with PC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Arm description

Anti-PD-(L)1 naïve participants with triple negative breast cancer (TNBC) received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Arm description

Anti-PD-(L)1 naïve participants with TNBC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Arm description

Anti-PD-(L)1 naïve participants with Head and Neck Squamous Cell Carcinoma (HNSCC) received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Arm description

Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Arm description

Participants with pre-treated (PT) PC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Arm description

Participants with PT PC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Arm description

Participants with PT TNBC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Arm description

Participants with PT TNBC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Arm description

Participants with PT HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Arm description

Participants with PT HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Arm type

Experimental

Investigational medicinal product name

Alomfilimab

Investigational medicinal product code

KY1044

Other name

SAR445256

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

A human anti-ICOS monoclonal antibody.

Investigational medicinal product name

Atezolizumab

Investigational medicinal product code

Other name

TECENTRIQ

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

An anti-PD-L1 monoclonal antibody.

Number of subjects in period 1	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 8 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 8 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC
Started	4	5	9	8	7	5	5	43	36	9	9	15	14	7	14	5	5	2	1	1	6	3	9
Treated	4	5	9	8	7	5	5	43	36	9	9	15	14	7	14	5	5	2	1	1	6	3	8
Completed	0	1	0	0	0	0	0	3	1	0	0	0	0	1	0	0	0	0	0	0	0	1	0
Not completed	4	4	9	8	7	5	5	40	35	9	9	15	14	6	14	5	5	2	1	1	6	2	9
Withdrawal of Consent	2	-	3	-	1	1	-	10	10	3	4	4	4	-	3	-	1	1	-	-	3	-	1
Lost to Follow Up	-	-	-	-	1	-	-	2	2	-	2	1	-	1	1	-	-	-	-	-	-	-	1
PD	-	-	-	2	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	1	-	-
Death	2	4	5	6	5	4	5	24	22	6	3	10	10	5	7	2	2	1	1	1	1	2	3
Miscellaneous	-	-	1	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1
Study Terminated by Sponsor	-	-	-	-	-	-	-	3	1	-	-	-	-	-	3	2	2	-	-	-	1	-	3

Baseline characteristics

Top of page

Reporting group title

Alomfilimab 0.8 mg

Reporting group description

Reporting group title

Alomfilimab 2.4 mg

Reporting group description

Reporting group title

Alomfilimab 8 mg

Reporting group description

Reporting group title

Alomfilimab 24 mg

Reporting group description

Reporting group title

Alomfilimab 80 mg

Reporting group description

Reporting group title

Alomfilimab 240 mg

Reporting group description

Reporting group title

Alomfilimab 0.8 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 24 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 80 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Reporting group description

Reporting group title

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Reporting group description

Reporting group title

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Reporting group description

Reporting group values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 8 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 8 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Total
Number of subjects	4	5	9	8	7	5	5	43	36	9	9	15	14	7	14	5	5	2	1	1	6	3	9	222
Age categorical
Units: Subjects
>= 18 – 64 years	2	2	6	2	4	3	2	27	27	5	5	8	5	6	10	3	4	1	0	1	4	3	3	133
>= 65 to 84 years	2	3	3	6	3	1	3	16	9	4	4	7	9	1	4	2	1	1	1	0	2	0	6	88
>= 85 years	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Gender categorical
Units: Subjects
Female	3	3	2	6	3	3	3	20	20	5	4	6	6	7	14	0	1	0	0	1	6	1	4	118
Male	1	2	7	2	4	2	2	23	16	4	5	9	8	0	0	5	4	2	1	0	0	2	5	104
Race
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
Asian	0	0	1	0	1	0	0	9	6	2	3	0	0	0	1	1	1	0	0	0	2	0	1	28
Black or African American	0	0	0	0	1	0	0	1	1	1	0	0	0	0	0	0	1	0	0	0	1	2	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
White	4	5	8	8	5	5	5	30	28	6	6	14	14	7	13	4	3	2	1	1	3	1	8	181
Other	0	0	0	0	0	0	0	2	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	4
Missing	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1

End points

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Reporting group title

Alomfilimab 0.8 mg

Reporting group description

Reporting group title

Alomfilimab 2.4 mg

Reporting group description

Reporting group title

Alomfilimab 8 mg

Reporting group description

Reporting group title

Alomfilimab 24 mg

Reporting group description

Reporting group title

Alomfilimab 80 mg

Reporting group description

Reporting group title

Alomfilimab 240 mg

Reporting group description

Reporting group title

Alomfilimab 0.8 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 24 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 80 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Reporting group description

Reporting group title

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Reporting group description

Reporting group title

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Reporting group description

Subject analysis set title

Alomfilimab 8 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Alomfilimab 8 mg + Atezolizumab

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Subject analysis set type

Safety analysis

Subject analysis set description

Primary: Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

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End point title

Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) ^[1] ^[2]

End point description

An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An serious AE (SAE) was any AE that: • resulted in death; • was life-threatening; • resulted in inpatient hospitalization or prolongation of existing hospitalization; • resulted in a persistent or significant disability/incapacity; • resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs; • constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment. Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).

End point type

Primary

End point timeframe

From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 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 additional statistics were pre-specified for this endpoint.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 1 only.

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 8 mg	Alomfilimab 8 mg + Atezolizumab
Number of subjects analysed	4	5	8	7	5	5	43	9	9	10	35
Units: participants
Any TEAEs	4	4	7	7	5	4	43	9	9	8	34
Any Serious TEAEs	1	1	2	3	2	2	17	4	3	3	11

No statistical analyses for this end point

Primary: Phase 1: Number of Participants Experiencing Dose Changes

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End point title

Phase 1: Number of Participants Experiencing Dose Changes ^[3] ^[4]

End point description

Dose changes were defined as infusion interruption and dose reduction. Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).

End point type

Primary

End point timeframe

From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks

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 additional statistics were pre-specified for this endpoint.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 1 only.

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 8 mg	Alomfilimab 8 mg + Atezolizumab
Number of subjects analysed	4	5	8	7	5	5	43	9	9	10	35
Units: participants
Infusion Interruption	1	0	1	1	0	0	2	0	2	0	0
Dose Reduction	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Phase 1: Absolute Dose Intensity

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End point title

Phase 1: Absolute Dose Intensity ^[5] ^[6]

End point description

Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks). Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).

End point type

Primary

End point timeframe

From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks

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 additional statistics were pre-specified for this endpoint.
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 1 only.

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 8 mg	Alomfilimab 8 mg + Atezolizumab
Number of subjects analysed	4	5	8	7	5	5	43	9	9	10	35
Units: mg/week
arithmetic mean (standard deviation)	0.260 ( 0.0000 )	0.778 ( 0.0179 )	7.799 ( 0.2694 )	26.174 ( 0.1952 )	76.650 ( 4.8260 )	0.236 ( 0.0288 )	0.780 ( 0.0176 )	7.418 ( 1.1455 )	25.774 ( 0.9037 )	2.616 ( 0.0427 )	2.573 ( 0.1159 )

No statistical analyses for this end point

Primary: Phase 1: Relative Dose Intensity

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End point title

Phase 1: Relative Dose Intensity ^[7] ^[8]

End point description

Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration. Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).

End point type

Primary

End point timeframe

From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks

Notes
[7] - 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 additional statistics were pre-specified for this endpoint.
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 1 only.

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 8 mg	Alomfilimab 8 mg + Atezolizumab
Number of subjects analysed	4	5	8	7	5	5	43	9	9	10	35
Units: ratio
arithmetic mean (standard deviation)	0.988 ( 0.0189 )	0.978 ( 0.0179 )	1.015 ( 0.0835 )	0.980 ( 0.0058 )	0.958 ( 0.0610 )	0.884 ( 0.1071 )	0.978 ( 0.0202 )	0.928 ( 0.1422 )	0.967 ( 0.0316 )	0.979 ( 0.0179 )	0.963 ( 0.0432 )

No statistical analyses for this end point

Primary: Phase 2: Overall Response Rate (ORR) Per RECIST 1.1

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End point title

Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 ^[9] ^[10]

End point description

ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% confidence interval (CI) was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with measurable disease at baseline only.

End point type

Primary

End point timeframe

From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 162 weeks

Notes
[9] - 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 additional statistics were pre-specified for this endpoint.
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 2 only.

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

0 (0.0 to 21.8)

0 (0.0 to 28.5)

0 (0.0 to 45.9)

7.1 (0.2 to 36.0)

0 (0.0 to 60.2)

0 (0.0 to 70.8)

0 (0.0 to 97.5)

0 (0.0 to 52.2)

33.3 (0.8 to 90.6)

0 (0.0 to 41.0)

No statistical analyses for this end point

Primary: Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)

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End point title

Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) ^[11] ^[12]

End point description

A DLT was defined as a clinically relevant AE or abnormal laboratory value of Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) ≥ Grade 3 assessed as unrelated to disease, PD, inter-current illness or concomitant medications, which occurs within the first cycle (21 days) of treatment with alomfilimab as single agent or in combination with atezolizumab during the dose escalation part of the study. Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).

End point type

Primary

End point timeframe

From first dose of study treatment (Day 1) up to 21 days

Notes
[11] - 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 additional statistics were pre-specified for this endpoint.
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 1 only.

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 8 mg	Alomfilimab 8 mg + Atezolizumab
Number of subjects analysed	4	5	8	7	5	5	43	9	9	10	35
Units: participants	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Best Overall Response (BOR) Per RECIST 1.1

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End point title

Best Overall Response (BOR) Per RECIST 1.1

End point description

BOR for each participant was defined as the best confirmed response per RECIST 1.1 among all responses recorded from start of treatment until PD, initiation of new anti-cancer therapy, death, or analysis cut-off date, whichever comes first, with responses of: CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. Not evaluable (NE). Analyzed in the Full Analysis Set.

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 8 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 8 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC
Number of subjects analysed	4	5	9	8	7	5	5	43	36	9	9	15	14	7	14	5	5	2	1	1	6	3	9
Units: participants
CR	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
PR	0	0	0	0	0	0	0	3	2	1	0	0	0	0	1	0	0	0	0	0	0	1	0
SD	1	0	2	2	2	1	3	12	8	1	4	6	0	1	4	2	1	0	1	0	2	0	3
PD	3	3	7	3	4	4	1	20	22	7	2	9	11	5	8	2	2	1	0	1	3	2	4
NE	0	2	0	3	1	0	1	7	4	0	3	0	3	1	1	1	2	1	0	0	1	0	2

No statistical analyses for this end point

Secondary: Progression-free Survival (PFS) Per RECIST 1.1

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End point title

Progression-free Survival (PFS) Per RECIST 1.1

End point description

PFS was calculated as (first documented PD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. Values of "-99999" or "99999" indicate N/A. Analyzed in the Full Analysis Set.

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively

Alomfilimab 0.8 mg

Alomfilimab 2.4 mg

Alomfilimab 8 mg

Alomfilimab 24 mg

Alomfilimab 80 mg

Alomfilimab 240 mg

Alomfilimab 0.8 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab

Alomfilimab 8 mg + Atezolizumab

Alomfilimab 24 mg + Atezolizumab

Alomfilimab 80 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Number of subjects analysed

Units: months

median (confidence interval 95%)

2 (2 to 99999)

2 (1 to 99999)

2 (1 to 6)

3 (1 to 99999)

2 (1 to 99999)

1 (1 to 99999)

3 (2 to 99999)

2 (2 to 4)

2 (2 to 2)

2 (1 to 4)

4 (2 to 99999)

2 (1 to 4)

2 (2 to 2)

2 (1 to 99999)

2 (1 to 4)

4 (2 to 99999)

2 (1 to 99999)

2 (-99999 to 99999)

3 (-99999 to 99999)

2 (-99999 to 99999)

4 (2 to 99999)

2 (2 to 99999)

3 (2 to 4)

No statistical analyses for this end point

Secondary: Duration of Response per RECIST 1.1

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End point title

Duration of Response per RECIST 1.1

End point description

Duration of response was calculated as (date of the first documentation of PD or to death due to any cause in the absence of PD - date of the first documentation of unconfirmed objective response [CR or PR] + 1]/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants with no disease assessment (or only had assessments with response = NE) after first study treatment or have assessments where the RECIST criteria could not be applied had their duration of response time censored. Duration of response was obtained via Kaplan Meier estimation. Values of "-99999" or "99999" indicate N/A.

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively

Alomfilimab 0.8 mg

Alomfilimab 2.4 mg

Alomfilimab 8 mg

Alomfilimab 24 mg

Alomfilimab 80 mg

Alomfilimab 240 mg

Alomfilimab 0.8 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab

Alomfilimab 8 mg + Atezolizumab

Alomfilimab 24 mg + Atezolizumab

Alomfilimab 80 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Number of subjects analysed

0 ^[13]

0 ^[14]

0 ^[15]

0 ^[16]

0 ^[17]

0 ^[18]

1 ^[19]

5 ^[20]

2 ^[21]

1 ^[22]

0 ^[23]

1 ^[24]

0 ^[25]

0 ^[26]

1 ^[27]

0 ^[28]

0 ^[29]

0 ^[30]

0 ^[31]

0 ^[32]

0 ^[33]

1 ^[34]

0 ^[35]

Units: months

median (confidence interval 95%)

( to )

11 (-99999 to 99999)

6 (2.1 to 99999)

99999 (13.9 to 99999)

11 (-99999 to 99999)

( to )

2 (-99999 to 99999)

( to )

13 (-99999 to 99999)

( to )

99999 (99999 to 99999)

( to )

Notes
[13] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[14] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[15] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[16] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[17] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[18] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[19] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[20] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[21] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[22] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[23] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[24] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[25] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[26] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[27] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[28] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[29] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[30] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[31] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[32] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[33] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[34] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.
[35] - Inclusive of those with observed events or participants that were censored. Analyzed in the FAS.

No statistical analyses for this end point

Secondary: ORR Per iRECIST

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End point title

ORR Per iRECIST

End point description

RECIST 1.1 has been modified to take into consideration the unique response kinetics which have been observed with immunotherapy in some patients where responses to immune therapies may occur after progression has been assessed. ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete immune-response (iCR) or partial immune-response (iPR) according to iRECIST as the best response. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). iCR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis). iPR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. Analysed in the Full Analysis Set.

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively

Alomfilimab 0.8 mg

Alomfilimab 2.4 mg

Alomfilimab 8 mg

Alomfilimab 24 mg

Alomfilimab 80 mg

Alomfilimab 240 mg

Alomfilimab 0.8 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab

Alomfilimab 8 mg + Atezolizumab

Alomfilimab 24 mg + Atezolizumab

Alomfilimab 80 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

0 (0.0 to 60.2)

0 (0.0 to 70.8)

0 (0.0 to 33.6)

0 (0.0 to 52.2)

0 (0.0 to 45.9)

0 (0.0 to 52.2)

0 (0.0 to 60.2)

9.3 (3.1 to 26.1)

5.6 (0.8 to 21.4)

11.1 (0.3 to 48.2)

0 (0.0 to 45.9)

0 (0.0 to 23.2)

0 (0.0 to 30.8)

0 (0.0 to 45.9)

7.1 (0.2 to 38.5)

0 (0.0 to 60.2)

0 (0.0 to 70.8)

0 (0.0 to 97.5)

0 (0.0 to 52.2)

33.3 (2.5 to 100.0)

0 (0.0 to 41.0)

No statistical analyses for this end point

Secondary: PFS Per iRECIST

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End point title

PFS Per iRECIST

End point description

PFS was calculated as (first documented iPD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. iPD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. Values of "-99999" or "99999" indicate N/A. Analyzed in the Full Analysis Set.

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively

Alomfilimab 0.8 mg

Alomfilimab 2.4 mg

Alomfilimab 8 mg

Alomfilimab 24 mg

Alomfilimab 80 mg

Alomfilimab 240 mg

Alomfilimab 0.8 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab

Alomfilimab 8 mg + Atezolizumab

Alomfilimab 24 mg + Atezolizumab

Alomfilimab 80 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Number of subjects analysed

Units: months

median (confidence interval 95%)

7 (-99999 to 99999)

10 (4.2 to 99999)

10 (3.4 to 99999)

6 (3.3 to 99999)

6 (2.7 to 99999)

6 (3.4 to 99999)

4 (2.5 to 99999)

7 (5.5 to 10)

5 (2.8 to 9.9)

3 (1.8 to 4.0)

5 (4.6 to 99999)

5 (2.5 to 99999)

5 (2.7 to 99999)

4 (2.6 to 99999)

10 (1.7 to 99999)

5 (5.0 to 99999)

4 (1.5 to 99999)

99999 (99999 to 99999)

10 (-99999 to 99999)

17 (-99999 to 99999)

12 (-99999 to 99999)

99999 (99999 to 99999)

6 (2.6 to 99999)

No statistical analyses for this end point

Secondary: Phase 1: ORR Per RECIST 1.1

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End point title

Phase 1: ORR Per RECIST 1.1 ^[36]

End point description

ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of CR or PR according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. Inclusive of participants with measurable disease at baseline only.

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 weeks

Notes
[36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 1 only.

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 8 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 8 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab
Number of subjects analysed	4	5	8	8	7	5	4	41	36	9	9
Units: percentage of participants
number (confidence interval 95%)	0 (0.0 to 60.2)	0 (0.0 to 70.8)	0 (0.0 to 33.6)	0 (0.0 to 52.2)	0 (0.0 to 45.9)	0 (0.0 to 52.2)	0 (0.0 to 60.2)	9.3 (3.1 to 26.1)	5.6 (0.8 to 20.8)	11.1 (0.3 to 48.2)	0 (0.0 to 45.9)

No statistical analyses for this end point

Secondary: Overall Survival Rate at 12 and 24 Months

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End point title

Overall Survival Rate at 12 and 24 Months

End point description

Overall Survival rate was defined as the proportion of participants that had known survival status. Overall survival rate was obtained via Kaplan Meier estimation using the complimentary log-log transformation method. Values of "-99999" and "99999" represent N/A. Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received.

End point type

Secondary

End point timeframe

Months 12 and 24

Alomfilimab 0.8 mg

Alomfilimab 2.4 mg

Alomfilimab 8 mg

Alomfilimab 24 mg

Alomfilimab 80 mg

Alomfilimab 240 mg

Alomfilimab 0.8 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab

Alomfilimab 8 mg + Atezolizumab

Alomfilimab 24 mg + Atezolizumab

Alomfilimab 80 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Number of subjects analysed

Units: proportion of participants

number (confidence interval 95%)

12 months

0.0 (-99999 to 99999)

0.2 (0.01 to 0.58)

0.4 (0.10 to 0.73)

0.3 (0.04 to 0.56)

0.4 (0.10 to 0.73)

0.0 (-99999 to 99999)

0.4 (0.05 to 0.75)

0.4 (0.27 to 0.60)

0.4 (0.22 to 0.57)

0.2 (0.01 to 0.64)

0.5 (0.12 to 0.82)

0.2 (0.03 to 0.47)

0.0 (-99999 to 99999)

0.6 (0.17 to 0.84)

0.7 (0.38 to 0.88)

99999 (99999 to 99999)

0.0 (-99999 to 99999)

99999 (99999 to 99999)

0.3 (0.01 to 0.77)

99999 (99999 to 99999)

24 months

0.0 (-99999 to 99999)

0.2 (0.01 to 0.58)

0.3 (0.04 to 0.61)

99999 (99999 to 99999)

0.0 (-99999 to 99999)

0.3 (0.13 to 0.43)

0.3 (0.11 to 0.44)

0.0 (-99999 to 99999)

99999 (99999 to 99999)

0.0 (-99999 to 99999)

0.2 (0.01 to 0.56)

0.4 (0.13 to 0.66)

99999 (99999 to 99999)

0.0 (-99999 to 99999)

99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Phase 2: Number of Participants Experiencing TEAEs

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End point title

Phase 2: Number of Participants Experiencing TEAEs ^[37]

End point description

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An SAE was any AE that: resulted in death; - was life-threatening; - resulted in inpatient hospitalization or prolongation of existing hospitalization; - resulted in a persistent or significant disability/incapacity; - resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs; - constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment. Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks

Notes
[37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 2 only.

End point values	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC
Number of subjects analysed	15	14	7	14	5	5	2	1	1	6	3	8
Units: participants
Any TEAEs	15	13	7	14	5	5	2	1	1	6	3	8
Any Serious TEAEs	6	2	1	2	1	1	1	0	0	2	1	4

No statistical analyses for this end point

Secondary: Phase 2: Number of Participants Experiencing Dose Changes

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End point title

Phase 2: Number of Participants Experiencing Dose Changes ^[38]

End point description

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks

Notes
[38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 2 only.

End point values	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC
Number of subjects analysed	15	14	7	14	5	5	2	1	1	6	3	8
Units: participants
Infusion Interruption	0	0	0	0	1	0	0	0	0	1	1	0
Dose Reduction	0	0	0	2	0	1	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Phase 2: Absolute Dose Intensity

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End point title

Phase 2: Absolute Dose Intensity ^[39]

End point description

Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks). Values of "99999" represent N/A. Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks

Notes
[39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 2 only.

End point values	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC
Number of subjects analysed	15	14	7	14	5	5	2	1	1	6	3	8
Units: mg/week
arithmetic mean (standard deviation)	0.778 ( 0.0540 )	2.559 ( 0.1712 )	0.777 ( 0.0111 )	2.536 ( 0.1628 )	2.366 ( 0.3577 )	6.818 ( 2.3926 )	0.775 ( 0.0212 )	2.640 ( 99999 )	0.760 ( 99999 )	2.607 ( 0.0841 )	2.613 ( 0.0551 )	7.794 ( 0.1676 )

No statistical analyses for this end point

Secondary: Phase 2: Relative Dose Intensity

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End point title

Phase 2: Relative Dose Intensity ^[40]

End point description

Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration. Values of "99999" represent N/A. Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).

End point type

Secondary

End point timeframe

From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks

Notes
[40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 2 only.

End point values	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC
Number of subjects analysed	15	14	7	14	5	5	2	1	1	6	3	8
Units: ratio
arithmetic mean (standard deviation)	0.973 ( 0.0660 )	0.956 ( 0.0638 )	0.976 ( 0.0113 )	1.014 ( 0.1256 )	0.886 ( 0.1316 )	0.980 ( 0.0274 )	0.975 ( 0.0212 )	0.990 ( 99999 )	0.960 ( 99999 )	0.977 ( 0.0333 )	0.980 ( 0.0200 )	0.973 ( 0.0191 )

No statistical analyses for this end point

Secondary: Phase 1: Maximum concentration (Cmax) of Alomfilimab

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End point title

Phase 1: Maximum concentration (Cmax) of Alomfilimab ^[41]

End point description

The serum pharmacokinetics (PK) of alomfilimab were characterized using non-compartmental analysis (NCA). Nominal times of sample collections were used for the NCA. All below limit of quantification (BLQ) values were set to 0 units. PK Evaluable Set: consisted of all participants who had sufficient concentration-time data within the relevant phase to permit calculation of PK parameters for alomfilimab.

End point type

Secondary

End point timeframe

Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)

Notes
[41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 1 only.

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 8 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 8 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab
Number of subjects analysed	4	5	9	7	7	5	5	35	29	8	9
Units: ug/mL
arithmetic mean (standard deviation)
Cycle 1 (n = 4, 5, 9, 7, 7, 5, 5, 35, 29, 8, 9)	0.3022 ( 0.12476 )	0.9773 ( 0.29919 )	3.3327 ( 0.95752 )	8.7301 ( 2.84671 )	33.7844 ( 12.98646 )	124.4294 ( 79.79754 )	0.3339 ( 0.17905 )	1.1201 ( 0.66885 )	3.3476 ( 1.23416 )	8.2597 ( 2.75396 )	31.4793 ( 10.38008 )
Cycle 3 (n = 3, 2, 7, 3, 5, 2, 3, 25, 21, 5, 6)	0.2671 ( 0.06805 )	1.2029 ( 0.24583 )	3.7461 ( 0.86853 )	30.5647 ( 39.72256 )	43.8045 ( 14.07259 )	141.8131 ( 62.54794 )	0.2840 ( 0.24914 )	1.6449 ( 3.01380 )	9.5099 ( 28.23379 )	10.2883 ( 3.86029 )	51.6622 ( 41.65071 )

No statistical analyses for this end point

Secondary: Phase 1: Half-life (t1/2) of Alomfilimab

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End point title

Phase 1: Half-life (t1/2) of Alomfilimab ^[42]

End point description

The serum PK of alomfilimab were characterized using NCA. Nominal times of sample collections were used for the NCA. All BLQ values were set to 0 units. Values of "99999" represent N/A. PK Evaluable Set: consisted of all participants who had sufficient concentration-time data within the relevant phase to permit calculation of PK parameters for alomfilimab.

End point type

Secondary

End point timeframe

Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)

Notes
[42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Endpoint was applicable for phase 1 only.

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 8 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 8 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab
Number of subjects analysed	4	5	9	8	7	5	4	36	30	8	9
Units: hours
arithmetic mean (standard deviation)
Cycle 1 (n = 4, 5, 9, 8, 7, 5, 4, 36, 30, 8, 9)	42.7633 ( 20.84762 )	72.2276 ( 9.56084 )	149.0872 ( 55.14152 )	226.2922 ( 75.20291 )	377.5444 ( 126.28273 )	356.4297 ( 109.96450 )	37.4777 ( 3.96733 )	93.0339 ( 33.82676 )	165.8783 ( 89.07566 )	174.9685 ( 79.39134 )	300.0089 ( 113.49910 )
Cycle 3 (n = 0, 1, 5, 2, 5, 1, 0, 15, 14, 2, 5)	99999 ( 99999 )	80.3268 ( 99999 )	215.6472 ( 98.90118 )	358.6064 ( 143.16181 )	342.6067 ( 193.81667 )	273.6673 ( 99999 )	99999 ( 99999 )	116.0599 ( 42.16269 )	202.0099 ( 78.48781 )	230.5514 ( 103.13822 )	440.0235 ( 236.99886 )

No statistical analyses for this end point

Secondary: Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime

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End point title

Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime

End point description

Detection of ADA was assessed from blood samples taken during the study using validated bioanalytical methods. The number of participants who developed detectable anti-alomfilimab or anti-atezolizumab antibodies during any cycle or the safety follow-up period (SFUP) was calculated. Values of "99999" represent N/A. Anti-drug Antibody Evaluable Set: consisted of all participants who received at least one dose of alomfilimab or atezolizumab and had ADA results available for analysis within the relevant phase.

End point type

Secondary

End point timeframe

Phase 1: pre-infusion at all cycles (up to 69 cycles) + 90 days SFUP; Phase 2: pre-infusion at all cycles (up to 28 cycles) + 90 day SFUP (21 day cycle length)

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 8 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 8 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC
Number of subjects analysed	4 ^[43]	3 ^[44]	8 ^[45]	8 ^[46]	7 ^[47]	5 ^[48]	5 ^[49]	36 ^[50]	34 ^[51]	8 ^[52]	6 ^[53]	13 ^[54]	11 ^[55]	6 ^[56]	12 ^[57]	5 ^[58]	3 ^[59]	1 ^[60]	1 ^[61]	0 ^[62]	6 ^[63]	3 ^[64]	7 ^[65]
Units: participants
≥ 1 Positive Anti-alomfilimab Antibodies Result	1	0	2	1	1	0	2	9	8	0	0	1	2	1	0	3	99999	1	0		0	1	99999
≥ 1 Positive Anti-atezolizumab Antibodies Result	99999	99999	99999	99999	99999	99999	1	8	8	4	1	5	2	1	0	1	0	0	0		0	1	1

Notes
[43] - Anti-alomfilimab n = 4; Anti-atezolizumab n = 0.
[44] - Anti-alomfilimab n = 3; Anti-atezolizumab n = 0.
[45] - Anti-alomfilimab n = 8; Anti-atezolizumab n = 0.
[46] - Anti-alomfilimab n = 8; Anti-atezolizumab n = 0.
[47] - Anti-alomfilimab n = 7; Anti-atezolizumab n = 0.
[48] - Anti-alomfilimab n = 5; Anti-atezolizumab n = 0.
[49] - Anti-alomfilimab n = 5; Anti-atezolizumab n = 5.
[50] - Anti-alomfilimab n = 36; Anti-atezolizumab n = 36.
[51] - Anti-alomfilimab n = 34; Anti-atezolizumab n = 34.
[52] - Anti-alomfilimab n = 8; Anti-atezolizumab n = 8.
[53] - Anti-alomfilimab n = 6; Anti-atezolizumab n = 6.
[54] - Anti-alomfilimab n = 13; Anti-atezolizumab n = 13.
[55] - Anti-alomfilimab n = 11; Anti-atezolizumab n = 11.
[56] - Anti-alomfilimab n = 6; Anti-atezolizumab n = 6.
[57] - Anti-alomfilimab n = 12; Anti-atezolizumab n = 12.
[58] - Anti-alomfilimab n = 4; Anti-atezolizumab n = 5.
[59] - Anti-alomfilimab n = 0; Anti-atezolizumab n = 3.
[60] - Anti-alomfilimab n = 1; Anti-atezolizumab n = 1.
[61] - Anti-alomfilimab n = 1; Anti-atezolizumab n = 1.
[62] - Anti-alomfilimab n = 0; Anti-atezolizumab n = 0.
[63] - Anti-alomfilimab n = 6; Anti-atezolizumab n = 6.
[64] - Anti-alomfilimab n = 3; Anti-atezolizumab n = 3.
[65] - Anti-alomfilimab n = 0; Anti-atezolizumab n = 7.

No statistical analyses for this end point

Secondary: Change from Baseline in Tumor-infiltrating Lymphocytes per mm^2 at Cycle 2 Day 8

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End point title

Change from Baseline in Tumor-infiltrating Lymphocytes per mm^2 at Cycle 2 Day 8

End point description

Biological samples (e.g., archived and fresh tumor samples or blood samples) were collected for analysis of responsive biomarkers. The summary of change in the following markers were calculated: - FOXP3-ICOS double-positive cells per mm^2 in the Tumor - CD8-positive cells per mm^2 in the tumor - CD8-positive cells per mm^2 in the invasive margin. Values of "99999" represent N/A. Biomarker Evaluable Set: consisted of all participants who received at least one dose of study drug and had at least one of ICOS, FOXP3 and CD8 cells results available for analysis within the relevant phase.

End point type

Secondary

End point timeframe

Baseline and Cycle 2 Day 8 (21 day cycle length)

End point values	Alomfilimab 0.8 mg	Alomfilimab 2.4 mg	Alomfilimab 8 mg	Alomfilimab 24 mg	Alomfilimab 80 mg	Alomfilimab 240 mg	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 8 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC
Number of subjects analysed	2 ^[66]	3 ^[67]	7 ^[68]	3 ^[69]	5 ^[70]	3 ^[71]	3 ^[72]	16 ^[73]	16 ^[74]	3 ^[75]	3 ^[76]	8 ^[77]	5 ^[78]	4 ^[79]	8 ^[80]	1 ^[81]	2 ^[82]	0 ^[83]	1 ^[84]	0 ^[85]	2 ^[86]	1 ^[87]	3 ^[88]
Units: cells per mm^2
arithmetic mean (standard deviation)
FOXP3-ICOS double-positive cells in tumor	0.275 ( 5.5649 )	21.905 ( 30.1015 )	-50.323 ( 42.9514 )	-42.210 ( 26.6714 )	-29.318 ( 28.0896 )	-67.160 ( 59.7524 )	-18.860 ( 33.2369 )	-129.334 ( 118.3340 )	-90.589 ( 115.9495 )	-117.610 ( 174.4591 )	-3.653 ( 6.5269 )	-58.865 ( 65.7823 )	-45.618 ( 34.5880 )	-51.293 ( 56.8048 )	-76.331 ( 63.0946 )	-437.660 ( 99999 )	-518.975 ( 668.5624 )	( )	-31.120 ( 99999 )	( )	-149.445 ( 137.0019 )	-197.940 ( 99999 )	-397.437 ( 307.3676 )
CD8-positive cells in tumor	-449.920 ( 99999 )	448.833 ( 443.5399 )	47.126 ( 294.7947 )	-105.110 ( 190.2826 )	-11.532 ( 169.8503 )	-371.857 ( 884.7449 )	-218.017 ( 282.9603 )	111.154 ( 939.3540 )	174.339 ( 693.8745 )	300.433 ( 325.6656 )	21.925 ( 56.3211 )	202.501 ( 588.9525 )	-63.528 ( 65.5904 )	318.470 ( 385.7782 )	320.923 ( 685.1093 )	-116.950 ( 99999 )	-1009.800 ( 99999 )	( )	-34.840 ( 99999 )	( )	181.120 ( 147.3752 )	-39.600 ( 99999 )	171.170 ( 293.3937 )
CD8-positive cells in invasive margin	99999 ( 99999 )	99999 ( 99999 )	-229.600 ( 114.8200 )	99999 ( 99999 )	336.140 ( 99999 )	99999 ( 99999 )	-422.680 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	-163.910 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )

Notes
[66] - FOXP3-ICOS n = 2; CD8-positive in tumor n = 1; CD8-positive in invasive margin n = 0.
[67] - FOXP3-ICOS n = 2; CD8-positive in tumor n = 3; CD8-positive in invasive margin n = 0.
[68] - FOXP3-ICOS n = 6; CD8-positive in tumor n = 7; CD8-positive in invasive margin n = 2.
[69] - FOXP3-ICOS n = 3; CD8-positive in tumor n = 3; CD8-positive in invasive margin n = 0.
[70] - FOXP3-ICOS n = 5; CD8-positive in tumor n = 5; CD8-positive in invasive margin n = 1.
[71] - FOXP3-ICOS n = 3; CD8-positive in tumor n = 3; CD8-positive in invasive margin n = 0.
[72] - FOXP3-ICOS n = 3; CD8-positive in tumor n = 3; CD8-positive in invasive margin n = 1.
[73] - FOXP3-ICOS n = 16; CD8-positive in tumor n = 14; CD8-positive in invasive margin n = 0.
[74] - FOXP3-ICOS n = 14; CD8-positive in tumor n = 16; CD8-positive in invasive margin n = 0.
[75] - FOXP3-ICOS n = 3; CD8-positive in tumor n = 3; CD8-positive in invasive margin n = 1.
[76] - FOXP3-ICOS n = 3; CD8-positive in tumor n = 2; CD8-positive in invasive margin n = 0.
[77] - FOXP3-ICOS n = 6; CD8-positive in tumor n = 8; CD8-positive in invasive margin n = 0.
[78] - FOXP3-ICOS n = 5; CD8-positive in tumor n = 5; CD8-positive in invasive margin n = 0.
[79] - FOXP3-ICOS n = 4; CD8-positive in tumor n = 3; CD8-positive in invasive margin n = 0.
[80] - FOXP3-ICOS n = 8; CD8-positive in tumor n = 8; CD8-positive in invasive margin n = 0.
[81] - FOXP3-ICOS n = 1; CD8-positive in tumor n = 1; CD8-positive in invasive margin n = 0.
[82] - FOXP3-ICOS n = 2; CD8-positive in tumor n = 1; CD8-positive in invasive margin n = 0.
[83] - FOXP3-ICOS n = 0; CD8-positive in tumor n = 0; CD8-positive in invasive margin n = 0.
[84] - FOXP3-ICOS n = 1; CD8-positive in tumor n = 1; CD8-positive in invasive margin n = 0.
[85] - FOXP3-ICOS n = 0; CD8-positive in tumor n = 0; CD8-positive in invasive margin n = 0.
[86] - FOXP3-ICOS n = 2; CD8-positive in tumor n = 2; CD8-positive in invasive margin n = 0.
[87] - FOXP3-ICOS n = 1; CD8-positive in tumor n = 1; CD8-positive in invasive margin n = 0.
[88] - FOXP3-ICOS n = 3; CD8-positive in tumor n = 3; CD8-positive in invasive margin n = 0.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

AEs: up to 30 days post last dose of study treatment, approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively

Adverse event reporting additional description

Presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.0

Reporting group title

Alomfilimab 8 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 24 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 0.8 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 240 mg

Reporting group description

Reporting group title

Alomfilimab 80 mg

Reporting group description

Reporting group title

Alomfilimab 24 mg

Reporting group description

Reporting group title

Alomfilimab 8 mg

Reporting group description

Reporting group title

Alomfilimab 2.4 mg

Reporting group description

Reporting group title

Alomfilimab 0.8 mg

Reporting group description

Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Reporting group description

Reporting group title

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Reporting group description

Anti-PD-(L)1 naïve participants with PC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Reporting group description

Participants with PT PC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Reporting group title

Alomfilimab 80 mg + Atezolizumab

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Reporting group description

Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Reporting group description

Reporting group title

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Reporting group description

Anti-PD-(L)1 naïve participants with TNBC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Reporting group description

Reporting group title

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Reporting group description

Reporting group title

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Reporting group description

Alomfilimab 8 mg + Atezolizumab

Alomfilimab 2.4 mg + Atezolizumab

Alomfilimab 24 mg + Atezolizumab

Alomfilimab 0.8 mg + Atezolizumab

Alomfilimab 240 mg

Alomfilimab 80 mg

Alomfilimab 24 mg

Alomfilimab 8 mg

Alomfilimab 2.4 mg

Alomfilimab 0.8 mg

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC

Alomfilimab 80 mg + Atezolizumab

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC

Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC

Total subjects affected by serious adverse events

subjects affected / exposed

11 / 35 (31.43%)

17 / 43 (39.53%)

4 / 9 (44.44%)

2 / 5 (40.00%)

3 / 7 (42.86%)

2 / 8 (25.00%)

3 / 10 (30.00%)

1 / 5 (20.00%)

1 / 4 (25.00%)

0 / 1 (0.00%)

2 / 6 (33.33%)

1 / 5 (20.00%)

6 / 15 (40.00%)

1 / 2 (50.00%)

3 / 9 (33.33%)

1 / 5 (20.00%)

2 / 14 (14.29%)

1 / 7 (14.29%)

2 / 14 (14.29%)

4 / 8 (50.00%)

1 / 3 (33.33%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

Colon cancer

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oesophageal carcinoma

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tumour associated fever

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

1 / 7 (14.29%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tumour haemorrhage

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Tumour pain

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 15 (6.67%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Embolism

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 15 (6.67%)

1 / 2 (50.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypotension

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Superior vena cava syndrome

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (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

Chills

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Chest pain

subjects affected / exposed

1 / 35 (2.86%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Death

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (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

Face oedema

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Medical device discomfort

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fatigue

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 14 (7.14%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyrexia

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

1 / 10 (10.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Dyspnoea

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 14 (7.14%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (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

Bronchial obstruction

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pleural effusion

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

2 / 6 (33.33%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 14 (7.14%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Stridor

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

1 / 5 (20.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Psychiatric disorders

Completed suicide

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

Investigations

Blood bilirubin increased

subjects affected / exposed

2 / 35 (5.71%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Infusion related reaction

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

1 / 9 (11.11%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Post procedural haemorrhage

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Procedural pain

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Wound complication

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Atrial fibrillation

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

1 / 9 (11.11%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (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

Brain oedema

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cerebrovascular accident

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dizziness

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 14 (7.14%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hemiplegia

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

1 / 9 (11.11%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Seizure

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

1 / 3 (33.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Spinal cord compression

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Syncope

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

1 / 8 (12.50%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Anaemia

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

1 / 5 (20.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal pain

subjects affected / exposed

0 / 35 (0.00%)

2 / 43 (4.65%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 5 (20.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

2 / 10 (20.00%)

1 / 5 (20.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

1 / 14 (7.14%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ascites

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 15 (6.67%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dysphagia

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

2 / 8 (25.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Mouth haemorrhage

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

1 / 5 (20.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Nausea

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (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

Obstruction gastric

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

1 / 5 (20.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oesophageal haemorrhage

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

Odynophagia

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

1 / 8 (12.50%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oesophageal stenosis

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Small intestinal obstruction

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

1 / 9 (11.11%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Upper gastrointestinal haemorrhage

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

1 / 14 (7.14%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Cholangitis

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

1 / 5 (20.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatic failure

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatic haemorrhage

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 15 (6.67%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Jaundice cholestatic

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

1 / 5 (20.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Urinary incontinence

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

1 / 8 (12.50%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract obstruction

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 5 (20.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Endocrine disorders

Inappropriate antidiuretic hormone secretion

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

1 / 5 (20.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Arthralgia

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Back pain

subjects affected / exposed

2 / 35 (5.71%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 15 (6.67%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 3

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune-mediated myositis

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neck pain

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

1 / 8 (12.50%)

0 / 3 (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

Appendicitis

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atypical pneumonia

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

1 / 7 (14.29%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Bacterial sepsis

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 15 (6.67%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

COVID-19 pneumonia

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

1 / 4 (25.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (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

Clostridium difficile infection

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Escherichia bacteraemia

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

1 / 15 (6.67%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infective exacerbation of chronic obstructive airways disease

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

2 / 9 (22.22%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

1 / 9 (11.11%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower respiratory tract infection

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia mycoplasmal

subjects affected / exposed

1 / 35 (2.86%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rhinovirus infection

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

1 / 8 (12.50%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sepsis

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Skin infection

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Soft tissue infection

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

1 / 9 (11.11%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

1 / 9 (11.11%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (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

Metabolism and nutrition disorders

Dehydration

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyponatraemia

subjects affected / exposed

0 / 35 (0.00%)

1 / 43 (2.33%)

1 / 9 (11.11%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Hypercalcaemia

subjects affected / exposed

0 / 35 (0.00%)

0 / 43 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 7 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

0 / 5 (0.00%)

0 / 4 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

0 / 5 (0.00%)

0 / 15 (0.00%)

0 / 2 (0.00%)

0 / 9 (0.00%)

0 / 5 (0.00%)

0 / 14 (0.00%)

0 / 7 (0.00%)

0 / 14 (0.00%)

0 / 8 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Alomfilimab 8 mg + Atezolizumab	Alomfilimab 2.4 mg + Atezolizumab	Alomfilimab 24 mg + Atezolizumab	Alomfilimab 0.8 mg + Atezolizumab	Alomfilimab 240 mg	Alomfilimab 80 mg	Alomfilimab 24 mg	Alomfilimab 8 mg	Alomfilimab 2.4 mg	Alomfilimab 0.8 mg	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT TNBC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 PT PC	Alomfilimab 80 mg + Atezolizumab	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve TNBC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve PC	Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC	Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 PT HNSCC
Total subjects affected by non serious adverse events
subjects affected / exposed	34 / 35 (97.14%)	39 / 43 (90.70%)	9 / 9 (100.00%)	4 / 5 (80.00%)	5 / 5 (100.00%)	7 / 7 (100.00%)	7 / 8 (87.50%)	7 / 10 (70.00%)	4 / 5 (80.00%)	4 / 4 (100.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	6 / 6 (100.00%)	5 / 5 (100.00%)	15 / 15 (100.00%)	2 / 2 (100.00%)	9 / 9 (100.00%)	5 / 5 (100.00%)	14 / 14 (100.00%)	7 / 7 (100.00%)	13 / 14 (92.86%)	8 / 8 (100.00%)	2 / 3 (66.67%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Uterine leiomyoma
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Tumour ulceration
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0
Tumour cavitation
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Tumour associated fever
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	1 / 7 (14.29%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Infected neoplasm
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0
Vascular disorders
Embolism
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0
Hypertension
subjects affected / exposed	0 / 35 (0.00%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0
Hypotension
subjects affected / exposed	1 / 35 (2.86%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	1	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Jugular vein thrombosis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Lymphoedema
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Superficial vein thrombosis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	2 / 35 (5.71%)	3 / 43 (6.98%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	2 / 7 (28.57%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	1 / 7 (14.29%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	3	0	1	0	3	1	0	0	1	0	0	0	0	0	0	1	0	0	1	0	0	0
Fatigue
subjects affected / exposed	10 / 35 (28.57%)	8 / 43 (18.60%)	1 / 9 (11.11%)	1 / 5 (20.00%)	3 / 5 (60.00%)	0 / 7 (0.00%)	2 / 8 (25.00%)	1 / 10 (10.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	1 / 2 (50.00%)	2 / 9 (22.22%)	2 / 5 (40.00%)	3 / 14 (21.43%)	1 / 7 (14.29%)	6 / 14 (42.86%)	4 / 8 (50.00%)	1 / 3 (33.33%)
occurrences all number	11	10	1	1	4	0	2	1	1	0	0	0	0	1	0	1	2	2	3	1	7	4	1
Influenza like illness
subjects affected / exposed	1 / 35 (2.86%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Malaise
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Chills
subjects affected / exposed	0 / 35 (0.00%)	3 / 43 (6.98%)	0 / 9 (0.00%)	1 / 5 (20.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	3	0	1	1	0	0	0	0	0	0	0	0	1	1	0	0	0	1	0	0	0	0
Chest pain
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Peripheral swelling
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pain
subjects affected / exposed	0 / 35 (0.00%)	2 / 43 (4.65%)	1 / 9 (11.11%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	1 / 7 (14.29%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	1	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Oedema peripheral
subjects affected / exposed	2 / 35 (5.71%)	3 / 43 (6.98%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	2 / 14 (14.29%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	3	0	1	0	0	0	0	0	0	0	0	1	0	1	0	1	0	2	0	2	0	0
Non-cardiac chest pain
subjects affected / exposed	1 / 35 (2.86%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Mucosal inflammation
subjects affected / exposed	0 / 35 (0.00%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0
Pyrexia
subjects affected / exposed	10 / 35 (28.57%)	9 / 43 (20.93%)	2 / 9 (22.22%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	1 / 5 (20.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 5 (0.00%)	3 / 14 (21.43%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	13	15	3	1	0	0	1	0	0	0	0	0	1	1	1	0	2	0	5	0	0	1	0
Swelling
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (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
Reproductive system and breast disorders
Erectile dysfunction
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Pelvic pain
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	2 / 8 (25.00%)	0 / 10 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	1	0	1	0	2	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vaginal haemorrhage
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Dysphonia
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Cough
subjects affected / exposed	5 / 35 (14.29%)	7 / 43 (16.28%)	0 / 9 (0.00%)	1 / 5 (20.00%)	1 / 5 (20.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	2 / 10 (20.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	3 / 6 (50.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	7	10	0	1	2	1	0	2	0	1	0	0	3	0	0	0	0	0	0	0	0	0	1
Epistaxis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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	2
Dyspnoea exertional
subjects affected / exposed	1 / 35 (2.86%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Dyspnoea
subjects affected / exposed	8 / 35 (22.86%)	1 / 43 (2.33%)	1 / 9 (11.11%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	2 / 10 (20.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	2 / 14 (14.29%)	0 / 7 (0.00%)	2 / 14 (14.29%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	11	1	1	1	0	0	0	2	0	1	0	0	1	0	1	0	0	0	2	0	2	0	0
Haemoptysis
subjects affected / exposed	2 / 35 (5.71%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	2 / 8 (25.00%)	0 / 3 (0.00%)
occurrences all number	2	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Immune-mediated lung disease
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0
Pulmonary embolism
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0
Pneumothorax
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Pleural effusion
subjects affected / exposed	0 / 35 (0.00%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	1	0	0	0	0
Paranasal sinus haemorrhage
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Oropharyngeal pain
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	1
Sinus congestion
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Rhinorrhoea
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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
Psychiatric disorders
Insomnia
subjects affected / exposed	2 / 35 (5.71%)	2 / 43 (4.65%)	0 / 9 (0.00%)	1 / 5 (20.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	1 / 3 (33.33%)
occurrences all number	2	2	0	1	1	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	2
Confusional state
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Depression
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Hallucination
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Terminal insomnia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (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
Anxiety
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Investigations
Amylase increased
subjects affected / exposed	1 / 35 (2.86%)	2 / 43 (4.65%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	1	3	1	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	2	0	0	1	0
Alanine aminotransferase increased
subjects affected / exposed	2 / 35 (5.71%)	3 / 43 (6.98%)	0 / 9 (0.00%)	2 / 5 (40.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	3 / 15 (20.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	3 / 14 (21.43%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	5	5	0	3	0	0	1	0	0	0	0	0	3	0	3	0	1	0	0	0	3	0	0
Activated partial thromboplastin time prolonged
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Aspartate aminotransferase increased
subjects affected / exposed	5 / 35 (14.29%)	5 / 43 (11.63%)	1 / 9 (11.11%)	2 / 5 (40.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	3 / 14 (21.43%)	0 / 7 (0.00%)	3 / 14 (21.43%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	10	6	1	4	0	0	1	0	0	0	0	0	1	0	1	0	2	0	3	0	3	0	0
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 35 (2.86%)	2 / 43 (4.65%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	2	1	0	0	0	0	0	0	0	0	0	0	0	2	1	0	0	0	0	2	0	0
Blood creatinine increased
subjects affected / exposed	2 / 35 (5.71%)	2 / 43 (4.65%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	3	1	0	0	2	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 35 (0.00%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	2 / 14 (14.29%)	1 / 7 (14.29%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	4	1	0	0	0
Blood cholesterol increased
subjects affected / exposed	2 / 35 (5.71%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood bilirubin increased
subjects affected / exposed	0 / 35 (0.00%)	2 / 43 (4.65%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	2 / 14 (14.29%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	3	0	2	0	0	1	0	0	0	0	0	0	0	1	0	1	0	0	0	2	0	0
Body temperature decreased
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Blood thyroid stimulating hormone increased
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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	1
Blood pressure increased
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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
Cardiac murmur
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Blood lactate dehydrogenase increased
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
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
Fibrin D dimer increased
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0
Gamma-glutamyltransferase
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Gamma-glutamyltransferase increased
subjects affected / exposed	2 / 35 (5.71%)	2 / 43 (4.65%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	2 / 14 (14.29%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	5	2	1	0	0	0	0	0	0	0	0	0	0	0	3	1	0	0	1	0	2	0	0
International normalised ratio increased
subjects affected / exposed	1 / 35 (2.86%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	3 / 15 (20.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	3	1	0	0	0	0	1	0	0
Lipase decreased
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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
Weight decreased
subjects affected / exposed	2 / 35 (5.71%)	0 / 43 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	0	1	0	0	1	1	0	0	0	0	0	0	0	1	0	0	1	2	0	0	0	0
Platelet count decreased
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0
Lymphocyte count decreased
subjects affected / exposed	2 / 35 (5.71%)	4 / 43 (9.30%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	3 / 14 (21.43%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	3	6	3	0	1	0	0	1	0	0	0	0	0	0	3	0	0	0	2	0	6	2	0
Lipase increased
subjects affected / exposed	2 / 35 (5.71%)	1 / 43 (2.33%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	1 / 3 (33.33%)
occurrences all number	2	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	5
White blood cell count decreased
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	2 / 14 (14.29%)	1 / 7 (14.29%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	1	0	0
Injury, poisoning and procedural complications
Post-traumatic pain
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Fall
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Post procedural haemorrhage
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Infusion related reaction
subjects affected / exposed	8 / 35 (22.86%)	9 / 43 (20.93%)	5 / 9 (55.56%)	0 / 5 (0.00%)	3 / 5 (60.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	1 / 10 (10.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	4 / 15 (26.67%)	1 / 2 (50.00%)	6 / 9 (66.67%)	1 / 5 (20.00%)	4 / 14 (28.57%)	0 / 7 (0.00%)	2 / 14 (14.29%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	8	14	5	0	3	0	1	1	0	1	0	0	0	0	7	1	6	1	4	0	3	0	0
Lumbar vertebral fracture
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Procedural pain
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0
Tooth fracture
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Stoma site inflammation
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Spinal fracture
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Procedural pneumothorax
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vascular access complication
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Palpitations
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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	2
Sinus tachycardia
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 35 (0.00%)	2 / 43 (4.65%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	3 / 8 (37.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	1 / 3 (33.33%)
occurrences all number	0	2	1	0	0	0	3	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	1
Coordination abnormal
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Aphasia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Dysgeusia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (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	1	0	0
Hemianopia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Headache
subjects affected / exposed	3 / 35 (8.57%)	2 / 43 (4.65%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	1 / 7 (14.29%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	3	4	2	0	1	1	0	1	0	0	0	2	0	0	1	0	0	0	1	2	0	0	2
Dysmetria
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Hypoaesthesia
subjects affected / exposed	2 / 35 (5.71%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Migraine
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Hemianopia homonymous
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Hypersomnia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Neuralgia
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Paraesthesia
subjects affected / exposed	1 / 35 (2.86%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	2	0
Peripheral motor neuropathy
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Peripheral sensory neuropathy
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Somnolence
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Sinus headache
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Presyncope
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Tremor
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	11 / 35 (31.43%)	9 / 43 (20.93%)	3 / 9 (33.33%)	0 / 5 (0.00%)	2 / 5 (40.00%)	1 / 7 (14.29%)	3 / 8 (37.50%)	2 / 10 (20.00%)	1 / 5 (20.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	2 / 5 (40.00%)	5 / 15 (33.33%)	1 / 2 (50.00%)	3 / 9 (33.33%)	1 / 5 (20.00%)	3 / 14 (21.43%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	20	15	3	0	3	4	3	2	1	1	0	0	1	2	8	2	5	2	6	0	2	0	2
Eosinophilia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Leukocytosis
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Iron deficiency anaemia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Leukopenia
subjects affected / exposed	1 / 35 (2.86%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	4 / 14 (28.57%)	2 / 7 (28.57%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	3	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	0	7	4	0	0	0
Lymph node pain
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Lymphopenia
subjects affected / exposed	5 / 35 (14.29%)	3 / 43 (6.98%)	2 / 9 (22.22%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	2 / 5 (40.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 5 (0.00%)	1 / 14 (7.14%)	1 / 7 (14.29%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	5	4	4	0	0	0	0	0	0	0	0	0	0	2	0	0	4	0	1	1	1	0	0
Neutropenia
subjects affected / exposed	0 / 35 (0.00%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 14 (7.14%)	1 / 7 (14.29%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	3	1	0	0	1
Neutrophilia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (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
Ear and labyrinth disorders
Tinnitus
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Hypoacusis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Vertigo
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Eye disorders
Dry eye
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0
Periorbital oedema
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Periorbital pain
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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
Vision blurred
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Abdominal distension
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	2 / 14 (14.29%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	2	0	0
Abdominal pain
subjects affected / exposed	3 / 35 (8.57%)	5 / 43 (11.63%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	2 / 8 (25.00%)	1 / 10 (10.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	1 / 2 (50.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	1 / 7 (14.29%)	2 / 14 (14.29%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	4	7	1	0	0	0	2	1	1	0	0	0	0	0	1	1	1	0	0	1	2	1	0
Abdominal pain upper
subjects affected / exposed	1 / 35 (2.86%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	1 / 7 (14.29%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	3	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	1	1	0	0
Ascites
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (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
Constipation
subjects affected / exposed	2 / 35 (5.71%)	3 / 43 (6.98%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 7 (14.29%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	1 / 2 (50.00%)	2 / 9 (22.22%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	3	1	0	1	1	1	0	0	1	0	0	0	0	2	1	2	0	1	0	0	0	0
Abdominal tenderness
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Aphthous ulcer
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Dyspepsia
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1
Dry mouth
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Diarrhoea
subjects affected / exposed	5 / 35 (14.29%)	5 / 43 (11.63%)	2 / 9 (22.22%)	0 / 5 (0.00%)	1 / 5 (20.00%)	2 / 7 (28.57%)	3 / 8 (37.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	2 / 14 (14.29%)	1 / 7 (14.29%)	1 / 14 (7.14%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	7	9	3	0	1	2	4	0	0	0	0	0	0	0	0	0	0	0	2	1	1	1	0
Dysphagia
subjects affected / exposed	4 / 35 (11.43%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	5	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Eructation
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Gastrooesophageal reflux disease
subjects affected / exposed	2 / 35 (5.71%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Flatulence
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Melaena
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Intestinal obstruction
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Nausea
subjects affected / exposed	3 / 35 (8.57%)	3 / 43 (6.98%)	0 / 9 (0.00%)	2 / 5 (40.00%)	0 / 5 (0.00%)	2 / 7 (28.57%)	3 / 8 (37.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	2 / 9 (22.22%)	1 / 5 (20.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	2 / 14 (14.29%)	2 / 8 (25.00%)	0 / 3 (0.00%)
occurrences all number	3	3	0	3	0	2	3	0	0	1	0	0	1	0	1	0	2	1	1	0	2	2	0
Toothache
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	1 / 9 (11.11%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Mouth haemorrhage
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Mouth ulceration
subjects affected / exposed	0 / 35 (0.00%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	4	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Stomatitis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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
Vomiting
subjects affected / exposed	4 / 35 (11.43%)	3 / 43 (6.98%)	3 / 9 (33.33%)	1 / 5 (20.00%)	1 / 5 (20.00%)	1 / 7 (14.29%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 5 (0.00%)	2 / 14 (14.29%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	6	4	5	1	1	1	1	0	0	0	0	0	0	0	0	0	2	0	2	0	0	1	0
Odynophagia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Hepatobiliary disorders
Hyperbilirubinaemia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (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	2	0	0
Skin and subcutaneous tissue disorders
Dry skin
subjects affected / exposed	1 / 35 (2.86%)	1 / 43 (2.33%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	1	1	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1
Dermatitis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Alopecia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Rash
subjects affected / exposed	4 / 35 (11.43%)	3 / 43 (6.98%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	3 / 7 (42.86%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	2 / 14 (14.29%)	1 / 7 (14.29%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	4	3	1	0	0	4	0	0	0	0	0	0	0	0	0	0	0	0	3	1	0	1	0
Eczema
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	2	0	0	0	0	0	0
Erythema
subjects affected / exposed	2 / 35 (5.71%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	1 / 7 (14.29%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Rash maculo-papular
subjects affected / exposed	1 / 35 (2.86%)	2 / 43 (4.65%)	0 / 9 (0.00%)	2 / 5 (40.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	1 / 7 (14.29%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	2	0	3	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	2	0	0	0
Skin plaque
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Pruritus
subjects affected / exposed	4 / 35 (11.43%)	4 / 43 (9.30%)	1 / 9 (11.11%)	2 / 5 (40.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	4	4	1	3	0	2	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	1	0
Rash vesicular
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Rash pruritic
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Rash papular
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Skin ulcer
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Renal and urinary disorders
Chromaturia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Dysuria
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0
Haematuria
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	1
Hydronephrosis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Urinary hesitation
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Endocrine disorders
Hypothyroidism
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	2 / 14 (14.29%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	3	0	0	0	1
Adrenal insufficiency
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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
Immune-mediated hypothyroidism
subjects affected / exposed	1 / 35 (2.86%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Musculoskeletal and connective tissue disorders
Flank pain
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0
Bone pain
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0
Muscle tightness
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (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
Arthralgia
subjects affected / exposed	4 / 35 (11.43%)	2 / 43 (4.65%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 7 (28.57%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	2 / 15 (13.33%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	6	3	2	0	0	2	0	0	0	0	0	0	1	0	2	1	0	0	2	0	0	1	0
Back pain
subjects affected / exposed	2 / 35 (5.71%)	5 / 43 (11.63%)	2 / 9 (22.22%)	1 / 5 (20.00%)	0 / 5 (0.00%)	2 / 7 (28.57%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	1 / 5 (20.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	6	2	1	0	2	0	0	0	0	0	0	0	0	2	0	1	1	1	0	1	0	0
Muscle spasms
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	2 / 7 (28.57%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	1	2	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0
Groin pain
subjects affected / exposed	1 / 35 (2.86%)	2 / 43 (4.65%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Muscular weakness
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Musculoskeletal pain
subjects affected / exposed	2 / 35 (5.71%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Musculoskeletal discomfort
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	1 / 7 (14.29%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	1 / 35 (2.86%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	1	2	0	0	0	2	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	1
Myalgia
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	3	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Osteoporosis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Neck pain
subjects affected / exposed	2 / 35 (5.71%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	2 / 7 (28.57%)	0 / 14 (0.00%)	2 / 8 (25.00%)	0 / 3 (0.00%)
occurrences all number	2	2	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	2	0	2	0
Rotator cuff syndrome
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Trismus
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0
Pain in extremity
subjects affected / exposed	2 / 35 (5.71%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	2	0	0	0	0	1	0	0	1	0	0	1	0	2	0	1	0	2	0	0	0	0
Pain in jaw
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (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	1	0
Rhabdomyolysis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Infections and infestations
Asymptomatic bacteriuria
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Catheter site infection
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (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
Bacteriuria
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (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
Eye infection
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Cystitis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Folliculitis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
COVID-19
subjects affected / exposed	0 / 35 (0.00%)	3 / 43 (6.98%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0	0
Candida infection
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Herpes zoster
subjects affected / exposed	1 / 35 (2.86%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0
Herpes zoster reactivation
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Mucosal infection
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Oral candidiasis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (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	1	0
Ophthalmic herpes zoster
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Nasopharyngitis
subjects affected / exposed	2 / 35 (5.71%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	1 / 3 (33.33%)
occurrences all number	2	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1
Hordeolum
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Lower respiratory tract infection
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (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
Respiratory tract infection
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Rhinitis
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	1 / 3 (33.33%)
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	1
Pneumonia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0
Sepsis
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Skin infection
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1
Sinusitis
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (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	1	0	0
Tinea pedis
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Tooth abscess
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Soft tissue infection
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Vaginal infection
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Upper respiratory tract infection
subjects affected / exposed	1 / 35 (2.86%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	2 / 8 (25.00%)	1 / 3 (33.33%)
occurrences all number	1	4	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	2	1
Tooth infection
subjects affected / exposed	0 / 35 (0.00%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	2 / 35 (5.71%)	5 / 43 (11.63%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	4	7	1	0	1	0	0	1	1	0	0	0	1	0	0	0	1	0	1	0	0	1	0
Metabolism and nutrition disorders
Hyperamylasaemia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (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
Dehydration
subjects affected / exposed	1 / 35 (2.86%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0	0	3	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0
Decreased appetite
subjects affected / exposed	7 / 35 (20.00%)	0 / 43 (0.00%)	1 / 9 (11.11%)	2 / 5 (40.00%)	2 / 5 (40.00%)	0 / 7 (0.00%)	2 / 8 (25.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	1 / 4 (25.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	5 / 14 (35.71%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	9	0	1	2	2	0	2	0	0	1	1	0	0	0	2	0	0	0	1	0	5	1	0
Hypercholesterolaemia
subjects affected / exposed	2 / 35 (5.71%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0
Hypercalcaemia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	0 / 14 (0.00%)	2 / 8 (25.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1	0	0	0	1	0	0	2	0
Cachexia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	1 / 5 (20.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0
Hyperlipasaemia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
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
Hyperkalaemia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0
Hyperglycaemia
subjects affected / exposed	2 / 35 (5.71%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	1 / 7 (14.29%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	2	1	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	0
Hypoalbuminaemia
subjects affected / exposed	2 / 35 (5.71%)	2 / 43 (4.65%)	1 / 9 (11.11%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	2	1	0	0	0	0	0	0	0	0	0	0	0	2	1	0	0	0	0	2	0	0
Hypocalcaemia
subjects affected / exposed	1 / 35 (2.86%)	0 / 43 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	1 / 15 (6.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	1 / 14 (7.14%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	1	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	1	0	1
Hypokalaemia
subjects affected / exposed	0 / 35 (0.00%)	0 / 43 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 6 (16.67%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 14 (7.14%)	0 / 7 (0.00%)	1 / 14 (7.14%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	0	0	0	1	1	0	0	2	0	0	0	0	1	0	2	0	0	0	3	0	1	1	0
Hypomagnesaemia
subjects affected / exposed	0 / 35 (0.00%)	3 / 43 (6.98%)	0 / 9 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	3	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Iron deficiency
subjects affected / exposed	2 / 35 (5.71%)	1 / 43 (2.33%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	2 / 5 (40.00%)	0 / 15 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 5 (20.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	2	0	0	0	1	0
Hyponatraemia
subjects affected / exposed	2 / 35 (5.71%)	2 / 43 (4.65%)	0 / 9 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 7 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)	0 / 5 (0.00%)	2 / 15 (13.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	2 / 5 (40.00%)	0 / 14 (0.00%)	0 / 7 (0.00%)	0 / 14 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	0	0	0	0	2	0	1	4	0	0	0	1	0

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Were there any global substantial amendments to the protocol? Yes

14 Nov 2018

Clinical Study Protocol Version 2.0.

14 Jan 2019

Clinical Study Protocol Version 3.0.

08 May 2019

Clinical Study Protocol Version 4.0.

28 Jul 2020

Clinical Study Protocol Version 5.0.

07 May 2021

Clinical Study Protocol Version 6.0.

10 Nov 2021

Clinical Study Protocol Version 7.0.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Primary: Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Primary: Phase 1: Number of Participants Experiencing Dose Changes

Primary: Phase 1: Number of Participants Experiencing Dose Changes

Primary: Phase 1: Absolute Dose Intensity

Primary: Phase 1: Absolute Dose Intensity

Primary: Phase 1: Relative Dose Intensity

Primary: Phase 1: Relative Dose Intensity

Primary: Phase 2: Overall Response Rate (ORR) Per RECIST 1.1

Primary: Phase 2: Overall Response Rate (ORR) Per RECIST 1.1

Primary: Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)

Primary: Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)

Secondary: Best Overall Response (BOR) Per RECIST 1.1

Secondary: Best Overall Response (BOR) Per RECIST 1.1

Secondary: Progression-free Survival (PFS) Per RECIST 1.1

Secondary: Progression-free Survival (PFS) Per RECIST 1.1

Secondary: Duration of Response per RECIST 1.1

Secondary: Duration of Response per RECIST 1.1

Secondary: ORR Per iRECIST

Secondary: ORR Per iRECIST

Secondary: PFS Per iRECIST

Secondary: PFS Per iRECIST

Secondary: Phase 1: ORR Per RECIST 1.1

Secondary: Phase 1: ORR Per RECIST 1.1

Secondary: Overall Survival Rate at 12 and 24 Months

Secondary: Overall Survival Rate at 12 and 24 Months

Secondary: Phase 2: Number of Participants Experiencing TEAEs

Secondary: Phase 2: Number of Participants Experiencing TEAEs

Secondary: Phase 2: Number of Participants Experiencing Dose Changes

Secondary: Phase 2: Number of Participants Experiencing Dose Changes

Secondary: Phase 2: Absolute Dose Intensity

Secondary: Phase 2: Absolute Dose Intensity

Secondary: Phase 2: Relative Dose Intensity

Secondary: Phase 2: Relative Dose Intensity

Secondary: Phase 1: Maximum concentration (Cmax) of Alomfilimab

Secondary: Phase 1: Maximum concentration (Cmax) of Alomfilimab

Secondary: Phase 1: Half-life (t1/2) of Alomfilimab

Secondary: Phase 1: Half-life (t1/2) of Alomfilimab

Secondary: Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime

Secondary: Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime

Secondary: Change from Baseline in Tumor-infiltrating Lymphocytes per mm^2 at Cycle 2 Day 8

Secondary: Change from Baseline in Tumor-infiltrating Lymphocytes per mm^2 at Cycle 2 Day 8

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies