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Clinical Trial Results:
A multi-site, Phase I/II, 2-part, dose escalation trial investigating the safety and immunogenicity of four prophylactic SARS-CoV-2 RNA vaccines against COVID-19 using different dosing regimens in healthy and immunocompromised adults

Summary
EudraCT number	2020-001038-36
Trial protocol	DE
Global end of trial date	13 Apr 2022

Results information
Results version number	v2(current)
This version publication date	24 Jan 2025
First version publication date	27 Apr 2023
Other versions	v1
Version creation reason	New data added to full data set An explanatory sentence was added to the endpoint "Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2)" to explain why not all arms/groups were evaluated.

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

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Trial information

Top of page

Sponsor protocol code

BNT162-01

ISRCTN number

US NCT number

NCT04380701

WHO universal trial number (UTN)

U1111-1249-4220

Sponsor organisation name

BioNTech SE

Sponsor organisation address

An der Goldgrube 12, Mainz, Germany, 55131

Public contact

BioNTech clinical trials patient information, BioNTech SE, 0049 613190840, patients@biontech.de

Scientific contact

BioNTech clinical trials patient information, BioNTech SE, 0049 613190840, patients@biontech.de

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

05 Sep 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Apr 2022

Was the trial ended prematurely?

Main objective of the trial

To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after single dose (SD; prime only) or prime/boost (P/B) immunization.

Protection of trial subjects

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

Background therapy

Evidence for comparator

Actual start date of recruitment

23 Apr 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 512

Worldwide total number of subjects

512

EEA total number of subjects

512

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)

434

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Study participants were selected from the volunteer panel at the clinical CRO, volunteers who responded to either generic or study-specific advertisements in social media, or volunteers who contacted the clinical CRO via a web-based study participant recruitment portal.

Screening details

Study participants were selected from this pool of volunteers according to inclusion and exclusion criteria. The first participant was enrolled on 23 APR 2020. All enrolled participants were allocated to treatment.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg

Arm description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162a1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular (IM); upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg

Arm description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162a1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg

Arm description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee [SRC]).

Arm type

Experimental

Investigational medicinal product name

BNT162a1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the SRC).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg

Arm description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), Immunocompromised participants (ICP) expansion cohort (Cohort 13).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen), ICP expansion cohort (Cohort 13). PT = post-transplant.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), alternative posology dose group expansion cohort (Cohort 11).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), adaptive immune response dose group expansion cohort (C12 = Cohort 12).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14

Arm description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), B-cell immune response dose group expansion cohort (C14 = Cohort 14).

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg

Arm description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162c2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg

Arm description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162c2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg

Arm description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162c2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg

Arm description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162c2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. For the P/B regimens, use of the same arm for both doses was allowed. The non-dominant arm was preferred.

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD

Arm description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (single dose [SD] regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162c2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD

Arm description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162c2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD

Arm description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162c2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD

Arm description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Arm type

Experimental

Investigational medicinal product name

BNT162c2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

Number of subjects in period 1	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
Started	12	12	6	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	15	15	30	90	20	12	12	12	12	12	12	12	12
Completed end of treatment phase	12	12	6	12	12	11	10	11	11	12	12	12	12	11	12	11	12	12	12	12	12	15	15	30	89	19	12	12	12	11	12	12	11	12
Completed	12	12	6	12	12	11	10	11	11	11	12	11	12	11	12	11	11	12	12	11	11	0	0	0	0	19	12	12	12	10	12	12	11	11
Not completed	0	0	0	0	0	1	2	1	1	1	0	1	0	1	0	1	1	0	0	1	1	15	15	30	90	1	0	0	0	2	0	0	1	1
Adverse event, serious fatal	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-
Consent withdrawn by subject	-	-	-	-	-	-	1	1	-	-	-	1	-	1	-	-	1	-	-	-	-	-	2	2	1	1	-	-	-	-	-	-	-	-
Physician decision	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	2	-	-	-	-	-	-	-	-	-
Adverse event, non-fatal	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	1	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Roll-over into trial BNT162-14	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	11	11	10	31	-	-	-	-	-	-	-	-	-
Non-trial SARS-COV-2 vaccination due to COVID-19	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	4	2	16	55	-	-	-	-	-	-	-	-	-
Pregnancy	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-
Private reason(s)	-	-	-	-	-	-	1	-	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	-	1	-	-	-	-
Lost to follow-up	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	1	-	-	-	-	-	1	-	-	-	1

Baseline characteristics

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Reporting group title

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg

Reporting group description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen).

Reporting group title

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg

Reporting group description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee [SRC]).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the SRC).

Reporting group title

BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), Immunocompromised participants (ICP) expansion cohort (Cohort 13).

Reporting group title

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen), ICP expansion cohort (Cohort 13). PT = post-transplant.

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), alternative posology dose group expansion cohort (Cohort 11).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12

Reporting group description

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), B-cell immune response dose group expansion cohort (C14 = Cohort 14).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (single dose [SD] regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Reporting group values	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD	Total
Number of subjects	12	12	6	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	15	15	30	90	20	12	12	12	12	12	12	12	12	512
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	50.80 ( 2.58 )	48.31 ( 9.04 )	38.22 ( 13.87 )	38.21 ( 10.48 )	41.44 ( 11.27 )	43.62 ( 11.03 )	39.42 ( 11.41 )	35.74 ( 8.60 )	33.88 ( 10.72 )	35.81 ( 12.50 )	64.31 ( 5.89 )	65.66 ( 5.95 )	67.16 ( 6.47 )	36.65 ( 10.14 )	39.64 ( 10.14 )	35.07 ( 10.46 )	42.75 ( 9.89 )	47.21 ( 6.43 )	65.44 ( 7.42 )	65.88 ( 6.56 )	63.87 ( 5.42 )	48.04 ( 10.36 )	48.93 ( 11.87 )	51.92 ( 13.57 )	55.59 ( 16.07 )	48.45 ( 13.87 )	36.42 ( 10.33 )	39.41 ( 12.34 )	34.47 ( 10.24 )	35.42 ( 9.68 )	40.03 ( 14.67 )	35.23 ( 11.88 )	42.40 ( 12.04 )	32.60 ( 10.87 )	-
Gender categorical
Units: Subjects
Female	5	6	1	7	6	8	4	4	6	5	5	10	8	5	7	8	10	4	4	6	8	3	9	13	45	10	8	5	3	8	10	8	5	7	261
Male	7	6	5	5	6	4	8	8	6	7	7	2	4	7	5	4	2	8	8	6	4	12	6	17	45	10	4	7	9	4	2	4	7	5	251
Ethnicity
Units: Subjects
Hispanic or Latino	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	2	0	0	1	0	0	6
Not Hispanic or Latino	12	12	6	11	12	12	12	12	12	11	12	12	12	12	12	12	12	12	12	12	12	15	15	30	89	20	12	12	10	12	12	11	12	12	506
Race
Units: Subjects
Asian	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	1	0	0	0	0	1	0	0	6
Black or African American	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	2
White	12	12	5	12	12	11	11	12	12	11	12	12	12	12	12	12	12	12	12	12	12	14	15	30	89	19	11	11	12	12	12	11	12	12	502
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1
Unknown or Not Reported	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Weight
Units: kilogram(s)
arithmetic mean (standard deviation)	77.68 ( 7.59 )	72.54 ( 10.85 )	78.58 ( 14.93 )	72.99 ( 14.79 )	77.11 ( 14.07 )	71.57 ( 14.09 )	73.58 ( 11.88 )	79.84 ( 13.81 )	76.73 ( 13.32 )	78.70 ( 13.85 )	71.90 ( 10.98 )	70.38 ( 9.14 )	69.98 ( 8.06 )	80.18 ( 14.13 )	77.08 ( 10.84 )	76.11 ( 11.67 )	72.45 ( 10.97 )	77.78 ( 8.43 )	77.87 ( 9.78 )	76.91 ( 12.38 )	75.80 ( 11.98 )	73.85 ( 9.67 )	73.50 ( 10.07 )	77.79 ( 12.92 )	75.44 ( 13.02 )	79.09 ( 14.94 )	67.45 ( 13.53 )	76.41 ( 15.66 )	72.44 ( 6.86 )	70.94 ( 11.43 )	63.75 ( 6.14 )	73.26 ( 15.39 )	73.48 ( 9.51 )	68.90 ( 11.56 )	-
Body mass index
Units: kilogram(s)/square metre
arithmetic mean (standard deviation)	24.61 ( 3.14 )	24.23 ( 2.78 )	24.73 ( 2.63 )	25.17 ( 2.89 )	24.94 ( 2.68 )	24.20 ( 2.32 )	24.34 ( 2.33 )	25.68 ( 3.44 )	25.52 ( 3.50 )	25.19 ( 3.09 )	24.73 ( 2.46 )	25.59 ( 2.22 )	25.63 ( 2.22 )	25.25 ( 3.26 )	25.50 ( 2.79 )	25.13 ( 2.07 )	25.43 ( 2.34 )	25.01 ( 1.38 )	25.43 ( 2.15 )	25.62 ( 2.47 )	25.85 ( 2.75 )	23.62 ( 1.90 )	25.63 ( 2.82 )	25.53 ( 2.72 )	25.08 ( 2.73 )	26.12 ( 2.96 )	23.31 ( 2.38 )	25.02 ( 2.85 )	23.83 ( 2.39 )	25.06 ( 3.73 )	22.82 ( 1.54 )	24.97 ( 3.17 )	24.19 ( 2.04 )	24.04 ( 2.59 )	-

End points

Top of page

Reporting group title

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg

Reporting group description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen).

Reporting group title

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg

Reporting group description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee [SRC]).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the SRC).

Reporting group title

BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), Immunocompromised participants (ICP) expansion cohort (Cohort 13).

Reporting group title

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen), ICP expansion cohort (Cohort 13). PT = post-transplant.

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), alternative posology dose group expansion cohort (Cohort 11).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12

Reporting group description

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), B-cell immune response dose group expansion cohort (C14 = Cohort 14).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (single dose [SD] regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Primary: Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose

Top of page

End point title

Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose ^[1]

End point description

Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Safety Set - all participants who received at least one dose of the IMP. 'Prime to D7' below indicates Prime up to Day 7 after Prime, 'Boost to D7' below indicates Boost up to Day 7 after Boost. 999 indicates data not available as the boost immunization was withheld for the BNT162a1 3 μg cohort and the BNT162b1 60 μg younger cohort following Safety Review Committee (SRC) decision. 9999 indicates data not available as the boost immunization was not administered to the BNT162c2 SD regimen cohorts.

End point type

Primary

End point timeframe

From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)

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 statistical analysis was planned for this endpoint.

End point values	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
Number of subjects analysed	12	12	6	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	15	15	30	90	20	12	12	12	12	12	12	12	12
Units: Participants
Prime to D7: any local reaction	9	11	6	6	5	10	12	11	12	12	7	11	11	6	9	12	12	10	7	9	9	12	14	16	82	20	4	3	8	11	4	7	5	11
Prime to D7: any severe/grade ≥3 local reaction	0	0	0	0	0	1	2	4	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Boost to D7: any local reaction	3	10	999	7	5	10	11	11	11	999	8	9	9	4	8	10	10	11	7	8	10	12	11	27	79	19	3	5	7	8	9999	9999	9999	9999
Boost to D7: any severe/grade ≥3 local reaction	0	0	999	2	0	0	0	2	3	999	0	0	0	0	0	0	0	0	1	0	1	0	0	2	2	1	0	0	0	0	9999	9999	9999	9999

No statistical analyses for this end point

Primary: Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose

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End point title

Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose ^[2]

End point description

Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Safety Set - all participants who received at least one dose of the IMP. Prime to D7 below indicates Prime up to Day 7 after Prime, Boost to D7 below indicates Boost up to Day 7 after Boost. 999 indicates data not available as the boost immunization was withheld for the BNT162a1 3 μg cohort and the BNT162b1 60 μg younger cohort following SRC decision. 9999 indicates data not available as the boost immunization was not administered to the BNT162c2 SD regimen cohorts.

End point type

Primary

End point timeframe

From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint.

End point values	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
Number of subjects analysed	12	12	6	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	15	15	30	90	20	12	12	12	12	12	12	12	12
Units: Participants
Prime to D7: any local reaction	6	12	6	9	8	8	11	11	12	12	9	10	11	9	9	12	9	9	3	4	9	12	14	12	68	15	5	8	9	12	7	7	4	8
Prime to D7: any severe/grade ≥3 local reaction	1	1	5	0	0	1	2	3	5	8	1	1	2	0	0	0	1	0	1	0	0	1	0	0	5	0	0	0	1	1	0	2	0	2
Boost to D7: any local reaction	3	12	999	7	7	9	10	11	11	999	8	10	12	4	2	7	10	10	4	8	11	13	12	21	78	16	3	7	6	9	9999	9999	9999	9999
Boost to D7: any severe/grade ≥3 local reaction	0	4	999	3	1	5	5	6	5	999	2	2	4	0	0	1	1	3	1	0	2	4	1	4	14	3	1	1	0	2	9999	9999	9999	9999

No statistical analyses for this end point

Primary: The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1

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End point title

The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1 ^[3]

End point description

TEAEs without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade ≥3 TEAE) using the Safety Set. Safety Set - all participants who received at least one dose of the IMP.

End point type

Primary

End point timeframe

28 days following Dose 1 or up to Dose 2 (whichever was first)

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 statistical analysis was planned for this endpoint.

End point values	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
Number of subjects analysed	12	12	6	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	15	15	30	90	20	12	12	12	12	12	12	12	12
Units: Percentage of participants
number (not applicable)
Any TEAE	8	33	83	8	0	50	33	42	42	58	25	17	58	25	50	50	8	42	25	33	25	7	53	13	26	35	17	33	17	17	50	58	25	25
Any grade ≥3 TEAE	0	0	0	0	0	0	8	0	0	0	8	8	8	0	0	8	0	0	0	0	17	0	7	0	2	5	0	0	0	8	0	0	0	0

No statistical analyses for this end point

Primary: The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2)

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End point title

The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) ^[4] ^[5]

End point description

TEAEs, without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade ≥3 TEAE) using the Safety Set. Safety Set - all participants who received at least one dose of the IMP. Per study protocol, this endpoint was only applicable for arms planned to receive two doses.

End point type

Primary

End point timeframe

28 days following Dose 2 or Dose 1 (if no Dose 2 was given)

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint.
[5] - 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: Data for the BNT162c2 Single Dose Cohorts are not reported for this endpoint as no Boost dose was planned.

End point values	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
Number of subjects analysed	12	12	6	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	15	15	30	90	20	12	12	12	12
Units: Percentage of participants
number (not applicable)
Any TEAE	17	33	83	58	8	75	50	58	67	58	25	33	75	58	58	67	25	50	33	58	33	13	73	40	49	45	33	42	33	17
Any grade ≥3 TEAE	0	0	0	0	0	0	25	0	0	0	8	8	17	0	0	8	0	8	8	8	17	0	7	3	4	10	0	8	0	8

No statistical analyses for this end point

Secondary: Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

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End point title

Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) ^[6]

End point description

At Day 1 (Baseline) and at 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one postbaseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 and/or Day 50 were scheduled before approval of protocol version 7 which implemented these visits. 999 indicates confidence interval not calculated as values of at least 3 participants were not available.

End point type

Secondary

End point timeframe

Up to 183 days following Dose 1

Notes
[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: This endpoint only reports data for the BNT162a1, BNT162b1, BNT162b2 Dose Ranging, and BNT162c2 Prime/Boost Cohorts.

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg

BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg

BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg

BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg

BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg

BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg

BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg

BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg

Number of subjects analysed

Units: Titer

geometric mean (confidence interval 95%)

Pre-Prime Immunization (Day 1)

5.0 (5.0 to 5.0)

5.1 (4.8 to 5.5)

5.0 (5.0 to 5.0)

6.9 (3.4 to 13.8)

5.0 (5.0 to 5.0)

7 days after Prime Immunization (Day 8)

5.0 (5.0 to 5.0)

5.1 (4.8 to 5.5)

5.0 (5.0 to 5.0)

8.2 (2.8 to 24.1)

5.0 (5.0 to 5.0)

21 days after Prime Immunization (Day 22)

5.0 (5.0 to 5.0)

10.0 (6.1 to 16.3)

6.9 (4.4 to 10.7)

10.0 (5.4 to 18.5)

11.7 (6.2 to 22.1)

29.1 (13.5 to 63.0)

20.6 (11.5 to 37.0)

13.7 (7.5 to 25.3)

16.3 (7.7 to 34.5)

15.4 (7.8 to 30.4)

16.3 (8.3 to 32.3)

5.3 (4.7 to 6.0)

7.5 (5.6 to 10.1)

16.6 (9.7 to 28.3)

16.3 (8.0 to 33.5)

15.9 (9.6 to 26.2)

8.4 (5.6 to 12.6)

7.9 (5.2 to 12.1)

49.0 (18.3 to 131.4)

5.0 (5.0 to 5.0)

5.3 (4.7 to 6.0)

7.1 (4.9 to 10.2)

7 days after Boost Immunization (Day 29)

9999 (9999 to 9999)

55.0 (32.5 to 93.1)

9999 (9999 to 9999)

181.5 (107.5 to 306.3)

9999 (9999 to 9999)

320.0 (183.6 to 557.7)

169.5 (70.3 to 408.7)

207.5 (94.0 to 458.0)

38.9 (16.1 to 93.5)

134.5 (82.2 to 220.1)

40.0 (-999 to 999)

213.6 (114.7 to 397.7)

329.4 (203.2 to 533.9)

127.0 (79.2 to 203.7)

164.7 (77.0 to 352.0)

678.1 (395.9 to 1161.2)

5.0 (5.0 to 5.0)

5.3 (4.7 to 6.0)

8.0 (4.8 to 13.4)

21 days after Boost Immunization (Day 43)

5.0 (5.0 to 5.0)

8.7 (3.8 to 19.8)

5.3 (4.6 to 6.1)

69.2 (33.0 to 145.4)

95.1 (47.0 to 192.7)

62.2 (30.4 to 127.0)

160.0 (90.3 to 283.6)

184.9 (96.8 to 353.0)

282.1 (136.8 to 581.6)

8.9 (6.1 to 13.0)

293.4 (179.9 to 478.5)

95.1 (42.3 to 214.0)

134.5 (66.8 to 270.8)

49.9 (26.9 to 92.6)

109.9 (71.1 to 169.8)

187.3 (119.9 to 292.6)

164.7 (89.3 to 303.6)

300.5 (182.7 to 494.1)

134.5 (85.4 to 214.1)

169.5 (115.3 to 249.2)

452.5 (255.6 to 801.1)

5.1 (4.8 to 5.5)

5.6 (4.9 to 6.5)

5.7 (4.8 to 6.6)

6.0 (4.6 to 8.0)

28 days after Boost Immunization (Day 50)

5.0 (-999 to 999)

9999 (9999 to 9999)

80.0 (36.1 to 177.5)

9999 (9999 to 9999)

82.3 (37.4 to 181.1)

9999 (9999 to 9999)

226.3 (120.5 to 424.8)

89.8 (37.5 to 214.9)

95.1 (50.9 to 178.0)

36.4 (20.8 to 63.8)

67.3 (35.7 to 126.7)

190.3 (118.4 to 305.7)

160.0 (84.6 to 302.5)

213.6 (148.8 to 306.6)

127.0 (75.7 to 213.0)

132.4 (91.8 to 191.0)

391.7 (229.4 to 668.8)

5.0 (5.0 to 5.0)

5.9 (5.0 to 7.1)

5.0 (5.0 to 5.0)

5.3 (4.7 to 6.0)

63 days after Boost Immunization (Day 85)

5.0 (5.0 to 5.0)

7.5 (3.9 to 14.5)

5.0 (5.0 to 5.0)

25.9 (14.6 to 46.0)

31.7 (14.5 to 69.4)

40.0 (21.1 to 76.0)

134.5 (70.0 to 258.6)

102.9 (58.1 to 182.2)

120.5 (56.1 to 258.7)

7.7 (5.2 to 11.4)

46.2 (25.4 to 84.0)

33.6 (16.6 to 68.1)

69.2 (33.8 to 142.0)

36.4 (19.3 to 68.6)

33.6 (19.9 to 57.0)

145.6 (85.5 to 247.8)

146.7 (80.9 to 265.9)

160.0 (97.4 to 263.0)

21.8 (12.1 to 39.2)

27.4 (17.5 to 42.9)

80.0 (39.1 to 163.5)

5.6 (5.0 to 6.3)

5.0 (5.0 to 5.0)

5.2 (4.7 to 5.8)

162 days after Boost Immunization (Day 184)

5.0 (5.0 to 5.0)

6.9 (3.4 to 13.8)

5.0 (5.0 to 5.0)

10.0 (6.1 to 16.4)

15.0 (9.0 to 24.8)

13.7 (8.8 to 21.4)

27.4 (14.0 to 53.6)

29.2 (13.9 to 61.2)

56.6 (22.3 to 143.6)

5.2 (4.8 to 5.5)

16.8 (10.0 to 28.2)

19.4 (10.7 to 35.1)

65.4 (31.7 to 134.8)

8.5 (5.6 to 13.0)

11.2 (7.8 to 16.2)

21.3 (12.2 to 37.3)

54.8 (31.5 to 95.5)

38.9 (20.6 to 73.2)

26.7 (14.1 to 50.4)

15.5 (11.8 to 20.5)

58.4 (30.6 to 111.3)

5.0 (5.0 to 5.0)

5.8 (4.2 to 7.9)

10.4 (3.4 to 31.5)

No statistical analyses for this end point

Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

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End point title

Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) ^[7]

End point description

At 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one postbaseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 and/or Day 50 were scheduled before approval of protocol version 7 which implemented these visits. 999 indicates confidence interval not calculated as values of at least 3 participants were not available.

End point type

Secondary

End point timeframe

Up to 183 days following Dose 1

Notes
[7] - 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: This endpoint only reports data for the BNT162a1, BNT162b1, BNT162b2 Dose Ranging, and BNT162c2 Prime/Boost Cohorts.

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg

BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg

BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg

BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg

BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg

BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg

BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg

BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg

Number of subjects analysed

Units: Titer

geometric mean (confidence interval 95%)

7 days after Prime Immunization (Day 8)

1.0 (1.0 to 1.0)

1.2 (0.8 to 1.7)

1.0 (1.0 to 1.0)

21 days after Prime Immunization (Day 22)

1.0 (1.0 to 1.0)

2.0 (1.2 to 3.3)

1.4 (0.9 to 2.1)

2.0 (1.1 to 3.7)

2.3 (1.2 to 4.4)

5.8 (2.7 to 12.6)

4.0 (2.2 to 7.3)

2.7 (1.5 to 5.1)

3.3 (1.5 to 6.9)

3.1 (1.6 to 6.1)

3.3 (1.7 to 6.5)

1.1 (0.9 to 1.2)

1.5 (1.1 to 2.0)

3.3 (1.9 to 5.7)

3.3 (1.6 to 6.7)

3.2 (1.9 to 5.2)

1.7 (1.1 to 2.5)

1.6 (1.0 to 2.4)

7.1 (4.3 to 11.9)

1.0 (1.0 to 1.0)

1.1 (0.9 to 1.2)

1.4 (1.0 to 2.0)

7 days after Boost Immunization (Day 29)

9999 (9999 to 9999)

11.0 (6.5 to 18.6)

9999 (9999 to 9999)

36.3 (21.5 to 61.3)

9999 (9999 to 9999)

64.0 (36.7 to 111.5)

33.9 (14.1 to 81.7)

41.5 (18.8 to 91.6)

7.8 (3.2 to 18.7)

26.9 (16.4 to 44.0)

8.0 (-999 to 999)

42.7 (22.9 to 79.5)

65.9 (40.6 to 106.8)

25.4 (15.8 to 40.7)

32.9 (15.4 to 70.4)

98.7 (62.2 to 156.5)

1.0 (1.0 to 1.0)

1.1 (0.9 to 1.2)

1.6 (1.0 to 2.7)

21 days after Boost Immunization (Day 43)

1.0 (1.0 to 1.0)

1.7 (0.8 to 4.0)

1.1 (0.9 to 1.2)

13.8 (6.6 to 29.1)

19.0 (9.4 to 38.5)

12.4 (6.1 to 25.4)

32.0 (18.1 to 56.7)

37.0 (19.4 to 70.6)

54.7 (26.5 to 112.8)

1.8 (1.2 to 2.6)

58.7 (36.0 to 95.7)

19.0 (8.5 to 42.8)

26.9 (13.4 to 54.2)

10.0 (5.4 to 18.5)

22.0 (14.2 to 34.0)

37.5 (24.0 to 58.5)

32.9 (17.9 to 60.7)

60.1 (36.5 to 98.8)

26.9 (16.9 to 42.8)

33.9 (23.1 to 49.8)

65.9 (45.5 to 95.3)

1.0 (1.0 to 1.1)

1.1 (1.0 to 1.3)

1.2 (0.9 to 1.6)

28 days after Boost Immunization (Day 50)

1.0 (-999 to 999)

9999 (9999 to 9999)

16.0 (7.2 to 35.5)

9999 (9999 to 9999)

16.5 (7.5 to 36.2)

9999 (9999 to 9999)

45.3 (24.1 to 85.0)

18.0 (7.5 to 43.0)

19.0 (10.2 to 35.6)

7.3 (4.2 to 12.8)

13.5 (7.1 to 25.3)

38.1 (23.7 to 61.1)

32.0 (16.9 to 60.5)

42.7 (29.8 to 61.3)

25.4 (15.1 to 42.6)

26.5 (18.4 to 38.2)

57.0 (38.6 to 84.3)

1.0 (1.0 to 1.0)

1.2 (1.0 to 1.4)

1.0 (1.0 to 1.0)

1.1 (0.9 to 1.2)

63 days after Boost Immunization (Day 85)

1.0 (1.0 to 1.0)

1.5 (0.8 to 2.9)

1.0 (1.0 to 1.0)

5.2 (2.9 to 9.2)

6.3 (2.9 to 13.9)

8.0 (4.2 to 15.2)

26.9 (14.0 to 51.7)

20.6 (11.6 to 36.4)

23.4 (10.8 to 50.4)

1.5 (1.0 to 2.3)

9.2 (5.1 to 16.8)

6.7 (3.3 to 13.6)

13.8 (6.8 to 28.4)

7.3 (3.9 to 13.7)

6.7 (4.0 to 11.4)

29.1 (17.1 to 49.6)

29.3 (16.2 to 53.2)

32.0 (19.5 to 52.6)

4.4 (2.4 to 7.8)

5.5 (3.5 to 8.6)

11.6 (7.3 to 18.7)

1.1 (1.0 to 1.3)

1.0 (1.0 to 1.0)

1.0 (0.9 to 1.2)

162 days after Boost Immunization (Day 184)

1.0 (1.0 to 1.0)

1.4 (0.7 to 2.8)

1.0 (1.0 to 1.0)

2.0 (1.2 to 3.3)

3.0 (1.8 to 5.0)

2.7 (1.8 to 4.3)

5.5 (2.8 to 10.7)

5.8 (2.8 to 12.2)

11.0 (4.3 to 28.2)

1.0 (1.0 to 1.1)

3.4 (2.0 to 5.6)

3.9 (2.1 to 7.0)

13.1 (6.3 to 27.0)

1.7 (1.1 to 2.6)

2.2 (1.6 to 3.2)

4.3 (2.4 to 7.5)

11.0 (6.3 to 19.1)

7.8 (4.1 to 14.6)

5.3 (2.8 to 10.1)

3.1 (2.4 to 4.1)

11.7 (6.1 to 22.3)

1.0 (1.0 to 1.0)

1.2 (0.8 to 1.6)

2.1 (0.7 to 6.3)

No statistical analyses for this end point

Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

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End point title

Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) ^[8]

End point description

End point type

Secondary

End point timeframe

Up to 183 days following Dose 1

Notes
[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: This endpoint only reports data for the BNT162a1, BNT162b1, BNT162b2 Dose Ranging, and BNT162c2 Prime/Boost Cohorts.

End point values	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg
Number of subjects analysed	12	12	6	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12	12
Units: Participants
7 days after Prime Immunization (Day 8)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
21 days after Prime Immunization (Day 22)	0	0	0	2	1	3	3	7	7	6	5	6	3	0	0	7	5	6	2	2	10	0	0	0	1
7 days after Boost Immunization (Day 29)	9999	9999	9999	9999	11	9999	11	9999	9999	9999	12	12	11	7	12	1	12	12	12	12	12	0	0	0	2
21 days after Boost Immunization (Day 43)	0	2	0	10	11	9	10	12	11	3	12	11	12	9	12	11	12	11	12	12	12	0	0	0	0
28 days after Boost Immunization (Day 50)	0	9999	9999	9999	11	9999	11	9999	9999	9999	12	11	12	9	11	12	12	12	12	11	12	0	0	0	0
63 days after Boost Immunization (Day 85)	0	2	0	9	8	9	10	11	11	1	10	8	10	8	9	11	12	12	8	7	12	0	0	0	0
162 days after Boost Immunization (Day 184)	0	1	0	3	6	4	7	8	10	0	5	7	10	3	2	6	10	11	7	4	10	0	0	1	2

No statistical analyses for this end point

Secondary: Functional Antibody Responses (Titers) for BNT162c2 (SD)

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End point title

Functional Antibody Responses (Titers) for BNT162c2 (SD) ^[9]

End point description

At Day 1 (Baseline) and at 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one postbaseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 of cohort 0.1 μg was scheduled before approval of protocol version 7 which implemented this visit.

End point type

Secondary

End point timeframe

Up to 183 days following Dose 1

Notes
[9] - 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: This endpoint only reports data for the BNT162c2 single dose cohorts.

End point values	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
Number of subjects analysed	12	12	12	12
Units: Titer
geometric mean (confidence interval 95%)
Pre-Prime Immunization (Day 1)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)
7 days after Prime Immunization (Day 8)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)
21 days after Prime Immunization (Day 22)	5.1 (4.8 to 5.5)	5.1 (4.8 to 5.5)	5.3 (4.7 to 6.0)	5.5 (4.8 to 6.3)
28 days after Prime Immunization (Day 29)	9999 (9999 to 9999)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	5.2 (4.8 to 5.6)
42 days after Prime Immunization (Day 43)	5.1 (4.8 to 5.5)	5.1 (4.8 to 5.5)	5.5 (4.5 to 6.6)	5.1 (4.8 to 5.5)
84 days after Prime Immunization (Day 85)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	6.0 (4.0 to 9.2)	5.0 (5.0 to 5.0)
183 days after Prime Immunization (Day 184)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	5.5 (4.5 to 6.8)	6.4 (3.7 to 11.3)

No statistical analyses for this end point

Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)

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End point title

Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) ^[10]

End point description

At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one postbaseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 of cohort 0.1 μg was scheduled before approval of protocol version 7 which implemented this visit.

End point type

Secondary

End point timeframe

Up to 183 days following Dose 1

Notes
[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: This endpoint only reports data for the BNT162c2 single dose cohorts.

End point values	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
Number of subjects analysed	12	12	12	12
Units: Titer
geometric mean (confidence interval 95%)
7 days after Prime Immunization (Day 8)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)
21 days after Prime Immunization (Day 22)	1.0 (1.0 to 1.1)	1.0 (1.0 to 1.1)	1.1 (0.9 to 1.2)	1.1 (1.0 to 1.3)
28 days after Prime Immunization (Day 29)	9999 (9999 to 9999)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.1)
42 days after Prime Immunization (Day 43)	1.0 (1.0 to 1.1)	1.0 (1.0 to 1.1)	1.1 (0.9 to 1.3)	1.0 (1.0 to 1.1)
84 days after Prime Immunization (Day 85)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.2 (0.8 to 1.8)	1.0 (1.0 to 1.0)
183 days after Prime Immunization (Day 184)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.1 (0.9 to 1.4)	1.3 (0.7 to 2.3)

No statistical analyses for this end point

Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)

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End point title

Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) ^[11]

End point description

At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as Day 29 of cohort 0.1 μg was scheduled before approval of protocol version 7 which implemented this visit.

End point type

Secondary

End point timeframe

Up to 183 days following Dose 1

Notes
[11] - 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: This endpoint only reports data for the BNT162c2 single dose cohorts.

End point values	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
Number of subjects analysed	12	12	12	12
Units: Participants
7 days after Prime Immunization (Day 8)	0	0	0	0
21 days after Prime Immunization (Day 22)	0	0	0	0
28 days after Prime Immunization (Day 29)	9999	0	0	0
42 days after Prime Immunization (Day 43)	0	0	0	0
84 days after Prime Immunization (Day 85)	0	0	1	0
183 days after Prime Immunization (Day 184)	0	0	0	1

No statistical analyses for this end point

Secondary: Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

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End point title

Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B) ^[12]

End point description

At Day 1 (Baseline) and at 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as, according to the protocol, Day 15 assessment was only performed for Cohort 14, and Day 36, Day 43, Day 85, and Day 365 assessments were only performed for Cohorts 11, 12, and 13. 999 indicates confidence interval not calculated as values of at least 3 participants were not available. 99999 indicates data not available as all participants crossed-over to study BNT162-14 before reaching Day 365 or were discontinued due to the reception of a non-trial vaccination.

End point type

Secondary

End point timeframe

Up to 1 year following Dose 1

Notes
[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: This endpoint only reports data for the BNT162b2 Expansion Cohorts.

End point values	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
Number of subjects analysed	15	15	30	90	20
Units: Titer
geometric mean (confidence interval 95%)
Pre-Prime Immunization (Day 1)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	5.1 (4.9 to 5.3)	5.0 (5.0 to 5.0)
7 days after Prime Immunization (Day 8)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)	5.4 (4.8 to 6.0)	5.3 (4.7 to 6.1)	6.6 (4.2 to 10.4)
14 days after Prime Immunization (Day 15)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	9.5 (4.8 to 18.7)
21 days after Prime Immunization (Day 22)	17.4 (9.8 to 30.9)	5.2 (4.7 to 5.8)	5.7 (4.8 to 6.8)	21.9 (17.5 to 27.3)	17.9 (9.5 to 33.7)
7 days after Boost Immunization (Day 29)	167.6 (112.0 to 250.7)	12.0 (5.5 to 26.4)	30.7 (21.3 to 44.1)	348.6 (270.8 to 448.8)	286.8 (183.1 to 449.4)
14 days after Boost Immunization (Day 36)	206.3 (116.8 to 364.3)	11.5 (5.3 to 24.8)	149.3 (104.0 to 214.4)	379.1 (306.0 to 469.6)	9999 (9999 to 9999)
21 days after Boost Immunization (Day 43)	167.6 (93.8 to 299.2)	9.8 (4.8 to 19.7)	119.9 (81.5 to 176.4)	307.8 (250.0 to 378.9)	9999 (9999 to 9999)
28 days after Boost Immunization (Day 50)	136.1 (76.2 to 243.0)	11.0 (5.1 to 23.7)	87.7 (62.3 to 123.7)	266.5 (215.9 to 328.8)	103.3 (70.8 to 150.6)
63 days after Boost Immunization (Day 85)	50.4 (30.7 to 82.7)	8.3 (5.0 to 13.7)	79.1 (56.7 to 110.2)	99.9 (81.3 to 122.7)	9999 (9999 to 9999)
162 days after Boost Immunization (Day 184)	27.0 (16.3 to 44.6)	11.9 (4.0 to 35.3)	19.2 (11.9 to 30.9)	29.5 (23.5 to 37.1)	49.8 (33.3 to 74.4)
343 days after Boost Immunization (Day 365)	99999 (99999 to 99999)	99999 (99999 to 99999)	7.1 (-999 to 999)	30.2 (11.7 to 78.2)	9999 (9999 to 9999)

No statistical analyses for this end point

Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

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End point title

Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B) ^[13]

End point description

At 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization). Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. 9999 indicates data not available as, according to the protocol, Day 15 assessment was only performed for Cohort 14, and Day 36, Day 43, Day 85, and Day 365 assessments were only performed for Cohorts 11, 12, and 13. 999 indicates confidence interval not calculated as values of at least 3 participants were not available. 99999 indicates data not available as all participants crossed-over to study BNT162-14 before reaching Day 365 or were discontinued due to the reception of a non-trial vaccination.

End point type

Secondary

End point timeframe

Up to 1 year following Dose 1

Notes
[13] - 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: This endpoint only reports data for the BNT162b2 Expansion Cohorts.

End point values	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
Number of subjects analysed	15	15	30	90	20
Units: Titer
geometric mean (confidence interval 95%)
7 days after Prime Immunization (Day 8)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.1 (1.0 to 1.2)	1.0 (1.0 to 1.1)	1.3 (0.8 to 2.1)
14 days after Prime Immunization (Day 15)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	1.9 (1.0 to 3.7)
21 days after Prime Immunization (Day 22)	3.5 (2.0 to 6.2)	1.0 (0.9 to 1.2)	1.1 (1.0 to 1.4)	4.3 (3.5 to 5.3)	3.6 (1.9 to 6.7)
7 days after Boost Immunization (Day 29)	33.5 (22.4 to 50.1)	2.4 (1.1 to 5.3)	6.1 (4.3 to 8.8)	68.4 (53.3 to 87.7)	57.4 (36.6 to 89.9)
14 days after Boost Immunization (Day 36)	41.3 (23.4 to 72.9)	2.3 (1.1 to 5.0)	29.9 (20.8 to 42.9)	74.3 (60.2 to 91.8)	9999 (9999 to 9999)
21 days after Boost Immunization (Day 43)	33.5 (18.8 to 59.8)	2.0 (1.0 to 3.9)	24.0 (16.3 to 35.3)	60.4 (49.2 to 74.1)	9999 (9999 to 9999)
28 days after Boost Immunization (Day 50)	27.2 (15.2 to 48.6)	2.2 (1.0 to 4.7)	17.5 (12.5 to 24.7)	52.3 (42.7 to 64.0)	20.7 (14.2 to 30.1)
63 days after Boost Immunization (Day 85)	10.1 (6.1 to 16.5)	1.7 (1.0 to 2.7)	15.8 (11.3 to 22.0)	19.6 (16.0 to 23.9)	9999 (9999 to 9999)
162 days after Boost Immunization (Day 184)	5.4 (3.3 to 8.9)	2.4 (0.8 to 7.1)	3.8 (2.4 to 6.2)	5.8 (4.6 to 7.2)	10.0 (6.7 to 14.9)
343 days after Boost Immunization (Day 365)	99999 (99999 to 99999)	99999 (99999 to 99999)	1.4 (-999 to 999)	5.4 (2.1 to 13.8)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

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End point title

Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B) ^[14]

End point description

End point type

Secondary

End point timeframe

Up to 1 year following Dose 1

Notes
[14] - 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: This endpoint only reports data for the BNT162b2 Expansion Cohorts.

End point values	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14
Number of subjects analysed	15	15	30	90	20
Units: Participants
7 days after Prime Immunization (Day 8)	0	0	1	1	2
14 days after Prime Immunization (Day 15)	9999	9999	9999	9999	4
21 days after Prime Immunization (Day 22)	7	0	1	54	9
7 days after Boost Immunization (Day 29)	15	4	22	88	19
14 days after Boost Immunization (Day 36)	15	4	30	88	9999
21 days after Boost Immunization (Day 43)	15	3	29	89	9999
28 days after Boost Immunization (Day 50)	15	4	30	89	19
63 days after Boost Immunization (Day 85)	13	2	28	84	9999
162 days after Boost Immunization (Day 184)	12	3	12	61	18
343 days after Boost Immunization (Day 365)	99999	99999	0	10	99999

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime]) up to Day 387 (approximately 12 months after Dose 2 [Boost]); other AEs: see below in section 'AE reporting additional description'.

Adverse event reporting additional description

Timeframe for AE reporting continued: Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg

Reporting group description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen).

Reporting group title

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg

Reporting group description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee [SRC]).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the SRC).

Reporting group title

BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg

Reporting group description

BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), expansion cohort (Cohort 13). ICP = Immunocompromised participants.

Reporting group title

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen), expansion cohort (Cohort 13). ICP = Immunocompromised participants, PT = post-transplant.

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), alternative posology dose group expansion cohort (Cohort 11). .

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12

Reporting group description

Reporting group title

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14

Reporting group description

BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), B-cell immune response dose group expansion cohort (C14 = Cohort 14).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (single dose [SD] regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

Reporting group title

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD

Reporting group description

BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen).

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg

BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg

BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg

BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg

BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg

BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg

BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg

BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg

BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg

BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg

BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV

BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT

BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12

BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD

BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD

BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD

Total subjects affected by serious adverse events

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

2 / 12 (16.67%)

0 / 12 (0.00%)

1 / 12 (8.33%)

3 / 12 (25.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

3 / 15 (20.00%)

0 / 30 (0.00%)

3 / 90 (3.33%)

1 / 20 (5.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

Oesophageal carcinoma

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

0 / 90 (0.00%)

0 / 20 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Ankle fracture

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

0 / 90 (0.00%)

0 / 20 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Femur fracture

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

1 / 90 (1.11%)

0 / 20 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Surgical and medical procedures

Hip arthroplasty

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

1 / 90 (1.11%)

0 / 20 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Myocardial infarction

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

1 / 90 (1.11%)

0 / 20 (0.00%)

0 / 12 (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

Nervous system disorders

Syncope

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

0 / 90 (0.00%)

0 / 20 (0.00%)

0 / 12 (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

Pelvic mass

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

0 / 90 (0.00%)

0 / 20 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Diverticulum intestinal haemorrhagic

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

0 / 90 (0.00%)

0 / 20 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Inguinal hernia

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

0 / 90 (0.00%)

0 / 20 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Umbilical hernia

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

0 / 90 (0.00%)

1 / 20 (5.00%)

0 / 12 (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

Cystitis

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

1 / 90 (1.11%)

0 / 20 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

3 / 15 (20.00%)

0 / 30 (0.00%)

0 / 90 (0.00%)

0 / 20 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

COVID-19

subjects affected / exposed

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 30 (0.00%)

0 / 90 (0.00%)

0 / 20 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg	BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg	BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg	BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg HIV	BNT162b2 - Part A ICP Aged 18 to 85 Years - 30 μg PT	BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C12	BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg C14	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg SD	BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg SD
Total subjects affected by non serious adverse events
subjects affected / exposed	9 / 12 (75.00%)	9 / 12 (75.00%)	5 / 6 (83.33%)	9 / 12 (75.00%)	2 / 12 (16.67%)	6 / 12 (50.00%)	12 / 12 (100.00%)	12 / 12 (100.00%)	12 / 12 (100.00%)	12 / 12 (100.00%)	3 / 12 (25.00%)	4 / 12 (33.33%)	9 / 12 (75.00%)	8 / 12 (66.67%)	7 / 12 (58.33%)	12 / 12 (100.00%)	10 / 12 (83.33%)	11 / 12 (91.67%)	4 / 12 (33.33%)	7 / 12 (58.33%)	4 / 12 (33.33%)	3 / 15 (20.00%)	11 / 15 (73.33%)	13 / 30 (43.33%)	48 / 90 (53.33%)	9 / 20 (45.00%)	4 / 12 (33.33%)	5 / 12 (41.67%)	4 / 12 (33.33%)	2 / 12 (16.67%)	10 / 12 (83.33%)	9 / 12 (75.00%)	5 / 12 (41.67%)	11 / 12 (91.67%)
Vascular disorders
Hot flush
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0	0	0	0	0	1	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Haematoma
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0
Hypertension
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	5 / 90 (5.56%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6	0	0	0	0	0	0	0	0	0
Hypotension
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	1	0	0	0	0	0	0	0	0	0	0	0
Systolic hypertension
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Diastolic hypotension
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Surgical and medical procedures
Dental care
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Mole excision
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
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	0	0	0	0	0	0	0	0	0	0	0	1
Papilloma excision
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Chills
subjects affected / exposed	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	2 / 90 (2.22%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	1	0	1	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0
Fatigue
subjects affected / exposed	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 6 (16.67%)	7 / 12 (58.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	6 / 12 (50.00%)	5 / 12 (41.67%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	4 / 12 (33.33%)	5 / 12 (41.67%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	2 / 90 (2.22%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 12 (25.00%)	4 / 12 (33.33%)	2 / 12 (16.67%)	3 / 12 (25.00%)
occurrences all number	1	3	1	7	0	0	7	7	1	0	0	0	0	2	1	5	6	1	0	0	0	0	0	0	2	0	0	0	0	0	3	5	2	3
Feeling hot
subjects affected / exposed	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
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	0	0	0	0	0	0	0	0	0	0	0	1
Influenza like illness
subjects affected / exposed	3 / 12 (25.00%)	8 / 12 (66.67%)	1 / 6 (16.67%)	4 / 12 (33.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	8 / 12 (66.67%)	10 / 12 (83.33%)	11 / 12 (91.67%)	10 / 12 (83.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	7 / 12 (58.33%)	2 / 12 (16.67%)	4 / 12 (33.33%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	2 / 15 (13.33%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 12 (16.67%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	5	14	1	7	0	0	8	16	21	10	0	0	0	3	0	7	2	4	2	0	0	0	2	0	0	0	0	0	0	1	2	2	0	2
Injection site reaction
subjects affected / exposed	9 / 12 (75.00%)	8 / 12 (66.67%)	1 / 6 (16.67%)	4 / 12 (33.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	8 / 12 (66.67%)	11 / 12 (91.67%)	12 / 12 (100.00%)	6 / 12 (50.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	11 / 12 (91.67%)	9 / 12 (75.00%)	10 / 12 (83.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	3 / 12 (25.00%)	9 / 12 (75.00%)
occurrences all number	10	15	1	7	0	0	11	19	20	6	0	0	0	2	0	21	9	10	0	0	0	0	0	2	0	0	0	0	2	0	1	2	3	9
Pyrexia
subjects affected / exposed	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 12 (16.67%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	2 / 90 (2.22%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	2	2	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2	0	0	0	0	0	0	0	0	0
Vessel puncture site paraesthesia
subjects affected / exposed	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Injection site discolouration
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Injection site discomfort
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	5 / 12 (41.67%)	3 / 12 (25.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	3 / 12 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	5	3	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	3	0	0
Injection site erythema
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Injection site haematoma
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	3 / 20 (15.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0
Injection site hypersensitivity
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Injection site hypoaesthesia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Injection site induration
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Injection site pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	3 / 12 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	4 / 12 (33.33%)	3 / 12 (25.00%)	1 / 12 (8.33%)	3 / 12 (25.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	2 / 90 (2.22%)	2 / 20 (10.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 12 (25.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	4	0	0	4	3	1	3	0	3	0	0	0	0	0	0	1	0	0	0	0	0	4	2	0	0	0	0	4	2	0	1
Malaise
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Axillary pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Non-cardiac chest pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vessel puncture site erythema
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vessel puncture site haematoma
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	1	0	0	0	0	0	0	0	0	0	0	0
Vessel puncture site pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vessel puncture site swelling
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Asthenia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Medical device site erythema
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	2 / 20 (10.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Peripheral swelling
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Discomfort
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0
Immune system disorders
Seasonal allergy
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Social circumstances
Physical disability
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	2 / 90 (2.22%)	2 / 20 (10.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	2	2	0	0	0	0	0	1	1	2
Amenorrhoea
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Breast discomfort
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	1 / 20 (5.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Vaginal haemorrhage
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	2 / 90 (2.22%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	1	0	0	0	2	0	1	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0
Rhinitis allergic
subjects affected / exposed	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	1 / 20 (5.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	1	0	0	0
Dyspnoea exertional
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nasal congestion
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	1	0
Oropharyngeal pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	1	1	0	0	2	0	6	1	1	1	0	0	0	0	0	0	0	0	0	0	0	1	1	1	0	0
Rhinorrhoea
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hallucination
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sleep disorder
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0
Insomnia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Adjustment disorder with depressed mood
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	1 / 20 (5.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Nervousness
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
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	0	0	0	0	0	0	0	0	0	0	0	1
Investigations
Body temperature increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
C-reactive protein increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Lymphocyte count increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Muscle strength abnormal
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Amylase increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood pressure systolic increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lipase increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Alanine aminotransferase increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0
Aspartate aminotransferase increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	1 / 90 (1.11%)	1 / 20 (5.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	1	0	0	0	0	0	0	0	0
Hepatic enzyme increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	2 / 90 (2.22%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0
Lymphocyte count decreased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Platelet count decreased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Weight increased
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Sunburn
subjects affected / exposed	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	2	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Thermal burn
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Animal bite
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	0	0	0	0	0	0	0	0	0	0	0
Arthropod sting
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Face injury
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin abrasion
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	0	0	0	0	0	0	2	0	0	0	0	0	0	0
Wound
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Cartilage injury
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Fall
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Joint injury
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	3 / 90 (3.33%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0
Ligament sprain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Meniscus injury
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Tooth fracture
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Arthropod bite
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0
Contusion
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Nasal injury
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Cardiac disorders
Tachycardia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Palpitations
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
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	0	0	0	0	0	0	0	0	0	0	0	0
Extrasystoles
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Supraventricular tachycardia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	2 / 12 (16.67%)	1 / 12 (8.33%)	1 / 6 (16.67%)	5 / 12 (41.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	8 / 12 (66.67%)	8 / 12 (66.67%)	5 / 12 (41.67%)	2 / 12 (16.67%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	4 / 12 (33.33%)	2 / 12 (16.67%)	1 / 12 (8.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	3 / 12 (25.00%)	0 / 15 (0.00%)	2 / 15 (13.33%)	3 / 30 (10.00%)	10 / 90 (11.11%)	2 / 20 (10.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	4 / 12 (33.33%)	3 / 12 (25.00%)	1 / 12 (8.33%)	5 / 12 (41.67%)
occurrences all number	2	1	2	10	0	3	15	12	5	2	1	0	1	0	1	4	3	1	1	2	4	0	2	4	10	4	1	1	4	0	4	4	1	5
Cervicobrachial syndrome
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dizziness
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	2 / 90 (2.22%)	1 / 20 (5.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	1	1	1	2	0	0	0	1	0	1	0	0	0	3	0	0	0	0	1	6	1	0	1	0	0	0	0	0	0
Head discomfort
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperaesthesia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Migraine
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Paraesthesia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0
Presyncope
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Taste disorder
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Tension headache
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypoaesthesia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Orthostatic intolerance
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	0	0	0	0	0	0	0	0	0	0	0
Sensory disturbance
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	0	0	0	0	0	0	0	0	0	0	0
Dysaesthesia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Anaemia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Lymph node pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Lymphopenia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	2 / 15 (13.33%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0
Neutropenia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Vertigo
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
External ear inflammation
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sudden hearing loss
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Tinnitus
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Ear disorder
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
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	0	0	0	0	0	0	0	0	0	0	0	1
Eye disorders
Asthenopia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Photophobia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blepharitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Conjunctival haemorrhage
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Eye haemorrhage
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Periorbital discomfort
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 6 (33.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Aphthous ulcer
subjects affected / exposed	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Abdominal pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (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	1	0	0	0	1	0	0	0	0	0	0	1	0	0
Abdominal pain lower
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Abdominal pain upper
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	1	1	0	0	0	0	0	0	0	0	0
Diarrhoea
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	1	0	3	1	1	0	0	0	0	0	0	2	0	2	0	0	0	0	1	0	2	0	0	0	0	1	3	0	1	0
Dry mouth
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dyspepsia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Dysphagia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Flatulence
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0
Gastrointestinal disorder
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gingival pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Vomiting
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Haemorrhoids thrombosed
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nausea
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1
Toothache
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	0	0	0	1	0	0	0	1	0	0	0	0	0	0	1	0	0	0
Gastrointestinal hypermotility
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Gingival swelling
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Haematochezia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Tongue ulceration
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Gingival bleeding
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin irritation
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Erythema
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Night sweats
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	3 / 90 (3.33%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	3	0	0	0	0	0	0	0	0	0
Pruritus
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Rash
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	1	0	0	0	0
Pityriasis rosea
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Alopecia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Renal and urinary disorders
Pollakiuria
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 12 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Renal colic
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Leukocyturia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	3 / 90 (3.33%)	1 / 20 (5.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	2	0	0	0	0	0	0	0	1	4	1	0	0	0	0	0	0	0	0
Back pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 15 (0.00%)	2 / 30 (6.67%)	7 / 90 (7.78%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	1	0	1	1	0	2	7	0	0	0	0	0	0	1	1	0
Muscle tightness
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	1	0	0	0	0	0	0	0	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	1	0	0	0	0	0	0	0	2	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Myalgia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 15 (13.33%)	0 / 15 (0.00%)	0 / 30 (0.00%)	4 / 90 (4.44%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	2	0	1	0	0	0	0	0	0	1	0	1	0	0	0	2	0	0	4	0	0	0	0	0	2	0	0	0
Neck pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	1 / 30 (3.33%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0
Muscle spasms
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Musculoskeletal pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Tendon pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Bone hypertrophy
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	1 / 20 (5.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0
Musculoskeletal stiffness
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Pain in jaw
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	1 / 20 (5.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Tenosynovitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Infections and infestations
Conjunctivitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Cystitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	2 / 90 (2.22%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0
Fungal infection
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Genital herpes
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gingivitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	1 / 20 (5.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	3	0	1	1	0	0	0	0	0	0	0	0	1	1	1	0	0	1	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	1	0	0	0	1	0	0	0	0	0
Tinea pedis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Cestode infection
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	0	0	0	0	0	0	0	0	0	0	0
Tonsillitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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	0	0	0	0	0	0	0	0	0	0	0
Cellulitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Herpes zoster
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Hordeolum
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	2 / 15 (13.33%)	0 / 30 (0.00%)	3 / 90 (3.33%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	3	0	0	0	0	0	0	0	0	0
Otitis externa
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Onychomycosis
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	3 / 12 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 15 (6.67%)	0 / 30 (0.00%)	0 / 90 (0.00%)	0 / 20 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	2	0	0	0	1	3	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	1
Polydipsia
subjects affected / exposed	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 15 (0.00%)	0 / 30 (0.00%)	1 / 90 (1.11%)	0 / 20 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

17 Apr 2020

This amendment described the replacement of the product code BNT162c1 with BNT162c2 and changes made in response to feedback from the Paul-Ehrlich-Institut (PEI).

13 May 2020

This amendment described a dose adjustment for the vaccine BNT162c2 and the corrections of some inconsistencies and ambiguities.

26 May 2020

This amendment described updates in response to feedback from the PEI and the Independent Ethics Committee (IEC) following protocol amendment 02 (protocol version 4.0, dated 13 May 2020).

09 Jun 2020

This amendment described adaption of the protocol to: • Allow the assessment of additional intermediate and low dose cohorts for BNT162b modRNA vaccine candidates to support identification of a suitable dose for Phase II/III evaluation. • Allow the assessment of BNT162b1 modRNA vaccine candidate in elderly subjects, given its favorable safety, tolerability, and immunogenicity profile in younger adults to date and recently available non-human primate immunogenicity data for the BNT162b1 and other modRNA vaccine candidates. • Plan the assessment of BNT162b2 modRNA vaccine candidate in elderly subjects. • Allow the assessment of P/B cohorts for the BNT162c2 saRNA vaccine candidate. • Allow revision of safety assessment & dose limiting toxicity criteria. • Add additional for blood draws for explorative biomarker/immunogenicity research purposes.

26 Jun 2020

This amendment described updates in response to feedback from the PEI following protocol amendment 04 (protocol version 6.0, dated 09 June 2020).

21 Jul 2020

This amendment described updates in response to feedback from the PEI and the IEC following protocol amendment 04 (protocol version 7.0, dated 26 June 2020). Changes were also implemented to align data collection and reporting in this trial with the data collection and reporting in other trials with BNT162 vaccines candidates (to facilitate data merging).

05 Oct 2020

This amendment implemented three additional cohorts (Cohorts 11, 12, and 13) comprising up to additional 150 trial participants aged from 18 to 85 years receiving BNT162b2 only. This amendment also: addressed feedback obtained from the PEI and the IEC following protocol amendment 05 (protocol version 8.0, dated 21 July 2020); introduces logistical simplifications; implemented changes to align data collection and reporting in this trial with the data collection and reporting in other trials with BNT162 vaccines candidates (to facilitate data merging).

28 Oct 2020

As requested by the IEC, this update reversed the reductions of the intervals between the dosing of trial participants implemented in protocol amendment 06 (protocol version 9.0, dated 05 October 2020) for Cohorts 1 to 10 and Cohort 13.

04 Dec 2020

This update implemented: a change in the sponsor name; deletion of the participant wellbeing calls given the available clinical data for BNT162b2; addition of text to avoid under reporting of mild COVID-19 related events arising in the trial; addition of a blood draw for CD4+ T-cell counting; removal of outdated content; correction of some errors; updates for clarification; updates of outdated data.

01 Mar 2021

This update implemented one additional independent cohort (Cohort 14) comprising an additional 20 trial participants receiving BNT162b2. Biomarker data from Cohort 14 were intended to provide characterization of B cell and plasma cell immune responses induced by BNT162b2, and to allow assessment of the durability of responses induced by vaccination in addition to continued follow-up of vaccine safety. There was also a change to concomitant medication reporting to allow capture of vaccinations, e.g., SARS-CoV-2 vaccinations.

12 Jan 2022

This update implemented changes to the follow-up visits of participants in Cohorts 11 to 13 who received non-trial SARS-CoV-2 vaccinations. For these participants, blood samples for immunogenicity and cell-mediated immune testing were not collected, and they were discontinued from this trial.

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

http://www.ncbi.nlm.nih.gov/pubmed/33514629
http://www.ncbi.nlm.nih.gov/pubmed/32998157
http://www.ncbi.nlm.nih.gov/pubmed/34044428
http://www.ncbi.nlm.nih.gov/pubmed/33915773
http://www.ncbi.nlm.nih.gov/pubmed/33888900
http://www.ncbi.nlm.nih.gov/pubmed/35040667
http://www.ncbi.nlm.nih.gov/pubmed/35653438
http://www.ncbi.nlm.nih.gov/pubmed/33524990

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Clinical trials

Clinical Trial Results: A multi-site, Phase I/II, 2-part, dose escalation trial investigating the safety and immunogenicity of four prophylactic SARS-CoV-2 RNA vaccines against COVID-19 using different dosing regimens in healthy and immunocompromised adults

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose

Primary: Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose

Primary: Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose

Primary: Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose

Primary: The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1

Primary: The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1

Primary: The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2)

Primary: The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2)

Secondary: Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

Secondary: Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)

Secondary: Functional Antibody Responses (Titers) for BNT162c2 (SD)

Secondary: Functional Antibody Responses (Titers) for BNT162c2 (SD)

Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)

Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)

Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)

Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)

Secondary: Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

Secondary: Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

Secondary: Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13 and 14; P/B)

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
A multi-site, Phase I/II, 2-part, dose escalation trial investigating the safety and immunogenicity of four prophylactic SARS-CoV-2 RNA vaccines against COVID-19 using different dosing regimens in healthy and immunocompromised adults