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Clinical Trial Results:
An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients with Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin’s Lymphoma and in Combination with Endocrine Therapy in Patients with Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Summary
EudraCT number	2012-002042-21
Trial protocol	FR
Global end of trial date	25 Jun 2021

Results information
Results version number	v1(current)
This version publication date	10 Jul 2022
First version publication date	10 Jul 2022
Other versions

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

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Trial information

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Sponsor protocol code

PMT4979g

ISRCTN number

US NCT number

NCT01296555

WHO universal trial number (UTN)

Sponsor organisation name

F. Hoffmann-La Roche AG

Sponsor organisation address

Grenzacherstrasse 124, Basel, Switzerland, CH-4070

Public contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com

Scientific contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

25 Jun 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

25 Jun 2021

Was the trial ended prematurely?

Yes

Main objective of the trial

The primary objective of this study was to assess the clinical efficacy of the combination of GDC-0032 and fulvestrant, as measured by the clinical benefit rate and objective response rate, in all participants and participants with PIK3CA-mutated breast cancer.

Protection of trial subjects

All participants (or their parents or guardians) were required to read and sign an Informed Consent Form.

Background therapy

Evidence for comparator

Actual start date of recruitment

16 Mar 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 28

Country: Number of subjects enrolled

Spain: 136

Country: Number of subjects enrolled

France: 18

Country: Number of subjects enrolled

United States: 492

Worldwide total number of subjects

674

EEA total number of subjects

154

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)

432

From 65 to 84 years

232

85 years and over

Subject disposition

Top of page

Recruitment details

Participants took part in this study at 30 centers in Canada, France, Spain, and United States from 16 March 2011 to 25 June 2021.

Screening details

Phase I: locally advanced or metastatic solid malignancy or NHL; post-menopausal locally advanced or metastatic hormone receptor-positive breast cancer (BC) +/- HER2-negative; NHL and DLBCL regardless of PIK3CA mutation; PIK3CA-mutant tumors. Phase II: post-menopausal locally advanced or metastatic HER2-negative, hormone receptor-positive BC.

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

Phase I, Stage 1: GDC-0032 3 milligrams (mg) once daily (QD)

Arm description

Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received taselisib 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles.

Phase I, Stage 1: GDC-0032 5 mg QD

Arm description

Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles.

Phase I, Stage 1: GDC-0032 8 mg QD

Arm description

Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles.

Phase I, Stage 1: GDC-0032 12 mg QD

Arm description

Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles.

Phase I, Stage 1: GDC-0032 16 mg QD

Arm description

Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles.

Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD

Arm description

Participants with PIK3CA-mutant breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 9 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles.

Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD

Arm description

Participants with PIK3CA-mutant solid tumors other than breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 9 mg capsules, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort C -GDC-0032 9 mg QD + Mida 5 mg

Arm description

Participants with any type of solid tumors were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD on Days 2 to 29 along with midazolam 5 mg syrup, orally, once on Days 1 and 16 of Cycle 1 (Cycle 1 duration=29 days) followed by GDC-0032 9 mg capsules, orally, QD in subsequent 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Midazolam

Investigational medicinal product code

Other name

Pharmaceutical forms

Syrup

Routes of administration

Oral use

Dosage and administration details

Participants received midazolam 5 mg syrup, orally, once on Days 1 and 16 of Cycle 1 (Cycle 1 duration=29 days) and QD in subsequent 28-day cycles.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 9 mg capsules, orally, QD on Days 2 to 29 and QD in subsequent 28-day cycles.

Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD

Arm description

Participants with HER2-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, soft, Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 9 mg capsules, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort E –GDC-0032 6 mg QD + Letro 2.5 mg QD

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 6 mg capsules, orally, QD in 28-day cycles.

Investigational medicinal product name

Letrozole

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received letrozole 2.5 mg capsules, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort E -GDC-0032 9 mg QD + Letro 2.5 mg QD

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Letrozole

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received letrozole 2.5 mg capsules, orally, QD in 28-day cycles.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 9 mg capsules, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulv 500 mg

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.

Arm type

Experimental

Investigational medicinal product name

Fulvestrant

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Participants received fulvestrant 500 mg, intramuscularly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 6 mg capsules, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulv 500 mg

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 9 mg capsules, orally, QD in 28-day cycles.

Investigational medicinal product name

Fulvestrant

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Participants received fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.

Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD

Arm description

Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 9 mg capsules, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD

Arm description

Participants with PIK3CA-mutant solid tumors that are non-breast and non-colorectal cancer were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle.

Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulv 500 mg

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28-day cycle.

Investigational medicinal product name

Fulvestrant

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Participants received fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.

Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulv 500 mg

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.

Arm type

Experimental

Investigational medicinal product name

Fulvestrant

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Participants received fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally, QD on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle.

Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulv 500 mg

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally, QD on Days 1-7 and 15-21 of each 28-day cycle.

Investigational medicinal product name

Fulvestrant

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Participants received fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.

Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulv 500 mg

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle until disease progression.

Arm type

Experimental

Investigational medicinal product name

Fulvestrant

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Participants received fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 2 mg tablets, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort N -GDC-0032 2 mg QD + Letro 2.5 mg QD

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Letrozole

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received letrozole 2.5 mg capsules, orally, QD in 28-day cycles.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 2 mg tablets, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort P -GDC-0032 4 mg QD + Letro 2.5 mg QD

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Letrozole

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received letrozole 2.5 mg capsules, orally, QD in 28-day cycles.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letro 2.5 mg QD

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 in 28-day cycles.

Investigational medicinal product name

Letrozole

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received letrozole 2.5 mg capsules, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letro 2.5 mg QD

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Letrozole

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received letrozole 2.5 mg capsules, orally, QD in 28-day cycles.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle.

Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letro 2.5 mg QD

Arm description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Letrozole

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received letrozole 2.5 mg capsules, orally, QD in 28-day cycles.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally on Days 1-7 and 15-21 of each 28-day cycle.

Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD

Arm description

Participants with non-Hodgkin’s lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally QD in 28-day cycles.

Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD

Arm description

Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD

Arm description

Participants with PIK3CA-mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 4 mg tablets, orally, QD in 28-day cycles.

Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD

Arm description

Participants with PIK3CA-mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 6 mg tablets, orally QD in 28-day cycles.

Phase II: GDC-0032 6 mg QD + Fulv 500 mg

Arm description

Postmenopausal participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer who had not previously received fulvestrant were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycles until disease progression.

Arm type

Experimental

Investigational medicinal product name

Fulvestrant

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Participants received fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.

Investigational medicinal product name

Taselisib

Investigational medicinal product code

Other name

GDC-0032

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received GDC-0032 6 mg tablets, orally, QD in 28-day cycles.

Number of subjects in period 1	Phase I, Stage 1: GDC-0032 3 milligrams (mg) once daily (QD)	Phase I, Stage 1: GDC-0032 5 mg QD	Phase I, Stage 1: GDC-0032 8 mg QD	Phase I, Stage 1: GDC-0032 12 mg QD	Phase I, Stage 1: GDC-0032 16 mg QD	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort C -GDC-0032 9 mg QD + Mida 5 mg	Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort E –GDC-0032 6 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort E -GDC-0032 9 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD	Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulv 500 mg	Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulv 500 mg	Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulv 500 mg	Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort N -GDC-0032 2 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort P -GDC-0032 4 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letro 2.5 mg QD	Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letro 2.5 mg QD	Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letro 2.5 mg QD	Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD	Phase II: GDC-0032 6 mg QD + Fulv 500 mg
Started	6	3	4	10	11	20	20	13	10	20	8	21	6	21	35	20	20	19	20	27	28	20	20	20	10	10	70	122	60
Completed	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0
Not completed	6	3	4	10	11	20	20	13	10	20	8	20	6	21	35	20	20	18	20	27	28	20	20	20	10	10	70	121	60
Adverse event, serious fatal	-	-	-	2	1	-	2	-	-	1	-	1	-	2	27	15	11	11	17	12	13	12	12	13	7	7	35	92	44
Consent withdrawn by subject	-	-	-	-	1	-	1	-	-	-	1	1	-	-	3	-	2	1	-	1	1	1	3	-	-	-	8	4	2
Physician decision	-	-	-	-	1	-	-	-	-	-	-	-	-	1	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-
Use of Another Anti-Cancer Therapy	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	2	-	-	-	-	-	-	-	-	-
Adverse event, non-fatal	-	-	1	1	2	4	1	4	3	1	-	4	1	4	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-
Study Terminated By Sponsor	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-
Reason Not Specified	-	-	-	-	-	-	-	-	-	-	-	-	-	1	2	3	7	4	3	7	11	5	5	7	2	2	19	11	9
Progressive Disease	6	3	3	7	6	16	16	8	7	18	7	14	5	12	1	1	-	-	-	1	-	-	-	-	1	-	5	1	-
Non-Compliance With Study Drug	-	-	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Lost to follow-up	-	-	-	-	-	-	-	-	-	-	-	-	-	-	2	1	-	2	-	2	3	2	-	-	-	-	3	13	5
Protocol deviation	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-

Baseline characteristics

Top of page

Reporting group title

Phase I, Stage 1: GDC-0032 3 milligrams (mg) once daily (QD)

Reporting group description

Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 5 mg QD

Reporting group description

Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 8 mg QD

Reporting group description

Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 12 mg QD

Reporting group description

Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 16 mg QD

Reporting group description

Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD

Reporting group description

Participants with PIK3CA-mutant solid tumors other than breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort C -GDC-0032 9 mg QD + Mida 5 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD

Reporting group description

Participants with HER2-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort E –GDC-0032 6 mg QD + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort E -GDC-0032 9 mg QD + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD

Reporting group description

Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.

Reporting group title

Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort N -GDC-0032 2 mg QD + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort P -GDC-0032 4 mg QD + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD

Reporting group description

Reporting group title

Phase II: GDC-0032 6 mg QD + Fulv 500 mg

Reporting group description

Reporting group values	Phase I, Stage 1: GDC-0032 3 milligrams (mg) once daily (QD)	Phase I, Stage 1: GDC-0032 5 mg QD	Phase I, Stage 1: GDC-0032 8 mg QD	Phase I, Stage 1: GDC-0032 12 mg QD	Phase I, Stage 1: GDC-0032 16 mg QD	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort C -GDC-0032 9 mg QD + Mida 5 mg	Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort E –GDC-0032 6 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort E -GDC-0032 9 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD	Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulv 500 mg	Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulv 500 mg	Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulv 500 mg	Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort N -GDC-0032 2 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort P -GDC-0032 4 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letro 2.5 mg QD	Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letro 2.5 mg QD	Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letro 2.5 mg QD	Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD	Phase II: GDC-0032 6 mg QD + Fulv 500 mg	Total
Number of subjects	6	3	4	10	11	20	20	13	10	20	8	21	6	21	35	20	20	19	20	27	28	20	20	20	10	10	70	122	60	674
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	51.0 ( 9.2 )	49.0 ( 12.5 )	66.3 ( 12.8 )	60.7 ( 15.4 )	57.9 ( 11.9 )	56.8 ( 11.6 )	62.6 ( 11.9 )	61.7 ( 9.6 )	50.4 ( 9.5 )	63.5 ( 9.7 )	59.1 ( 7.6 )	59.8 ( 11.9 )	55.0 ( 9.7 )	64.4 ( 10.0 )	64.3 ( 11.8 )	61.8 ( 7.7 )	62.8 ( 9.1 )	54.3 ( 12.7 )	55.7 ( 11.9 )	63.1 ( 9.1 )	59.7 ( 12.5 )	57.2 ( 13.9 )	58.3 ( 8.9 )	59.5 ( 10.6 )	66.1 ( 7.8 )	53.9 ( 19.3 )	60.6 ( 13.4 )	58.9 ( 11.9 )	60.3 ( 12.2 )	-
Sex: Female, Male
Units: participants
Female	4	2	2	9	6	19	12	6	10	20	8	21	6	16	22	20	20	19	20	27	28	20	20	19	6	2	37	83	60	544
Male	2	1	2	1	5	1	8	7	0	0	0	0	0	5	13	0	0	0	0	0	0	0	0	1	4	8	33	39	0	130
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	2
Asian	0	0	0	1	1	0	0	0	0	0	0	1	0	0	1	0	0	1	2	1	0	1	0	0	0	0	4	3	3	19
Black or African American	0	0	0	1	0	1	0	0	0	0	0	0	0	0	1	1	0	1	0	0	1	1	2	0	0	0	2	4	3	18
Native Hawaiian or other Pacific Islande	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2
White	6	3	4	8	8	18	20	12	10	20	8	19	6	20	30	19	20	17	17	26	27	18	18	20	10	9	57	109	53	612
Other	0	0	0	0	1	1	0	1	0	0	0	1	0	0	3	0	0	0	1	0	0	0	0	0	0	0	7	5	0	20
Multiple	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1
Race/Ethnicity, Customized
Units: Subjects
Hispanic or Latino	1	0	0	1	0	1	0	0	0	0	0	1	0	2	1	2	0	1	0	0	2	1	0	0	0	2	5	6	0	26
Not Hispanic or Latino	5	3	4	7	10	19	20	12	9	18	8	20	6	18	31	17	20	17	18	24	25	18	19	20	10	8	61	108	56	611
Unknown	0	0	0	2	0	0	0	1	0	1	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	2	2	1	11
Not Reported	0	0	0	0	1	0	0	0	1	1	0	0	0	0	3	1	0	1	1	3	1	1	1	0	0	0	2	6	3	26

End points

Top of page

Reporting group title

Phase I, Stage 1: GDC-0032 3 milligrams (mg) once daily (QD)

Reporting group description

Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 5 mg QD

Reporting group description

Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 8 mg QD

Reporting group description

Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 12 mg QD

Reporting group description

Participants received GDC-0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 16 mg QD

Reporting group description

Participants received GDC-0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD

Reporting group description

Participants with PIK3CA-mutant solid tumors other than breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort C -GDC-0032 9 mg QD + Mida 5 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD

Reporting group description

Participants with HER2-positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort E –GDC-0032 6 mg QD + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort E -GDC-0032 9 mg QD + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD

Reporting group description

Participants with solid tumors with increased PIK3CA copy number were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in each 28-day cycle until disease progression.

Reporting group title

Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulv 500 mg

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort N -GDC-0032 2 mg QD + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort P -GDC-0032 4 mg QD + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letro 2.5 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD

Reporting group description

Reporting group title

Phase II: GDC-0032 6 mg QD + Fulv 500 mg

Reporting group description

Subject analysis set title

Phase I, Stage 1: GDC-0032 3 mg QD

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Subject analysis set title

All Cohorts (Except T and T2)

Subject analysis set type

Safety analysis

Subject analysis set description

Participants from Cohorts from Phase I Stage 1, Cohorts A, B, C, D, E, F, G, H, J, K, L, M, N, P, Q, R, S, X and Phase 2 were included in this analysis.

Subject analysis set title

Cohorts T and T2

Subject analysis set type

Safety analysis

Subject analysis set description

Participants from Cohorts T and T2 of Phase I, Stage 2 were included in this analysis.

Subject analysis set title

GDC-0032 Monotherapy

Subject analysis set type

Safety analysis

Subject analysis set description

Participants who received GDC-0032 as monotherapy in Stage 1, Stage 2 (Cohorts A, B, C, D, G, H, T, T2, X) of Phase 1, and in Phase 2 were included in this analysis population.

Subject analysis set title

GDC-0032 + Letrozole

Subject analysis set type

Safety analysis

Subject analysis set description

Participants who received GDC-0032 in combination with letrozole in Stage 2 (Cohorts E, N, P, Q, R, S) were included in this analysis population.

Subject analysis set title

GDC-0032 + Fulvestrant

Subject analysis set type

Safety analysis

Subject analysis set description

Participants who received GDC-0032 in combination with fulvestrant in Stage 2 (Cohorts F, J, K, L, M) of Phase 1, and in Phase 2 were included in this analysis population.

Subject analysis set title

Cohort E

Subject analysis set type

Safety analysis

Subject analysis set description

Participants from Cohort E of Phase I, Stage 2 were included in this analysis.

Primary: Phase I Stage 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0)

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End point title

Phase I Stage 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) ^[1] ^[2]

End point description

A DLT is defined as any one of the following toxicities occurring within the DLT Assessment Window (Days 1-35 of Cycle 1 in Stage 1) assessed by the investigator: Grade ≥ 3 non-hematologic, non-hepatic organ system, non-metabolic (hyperglycemia and hyperlipidemia) toxicity, excluding alopecia of any grade, Grade 3 diarrhea, Grade 3 nausea or vomiting; Grade ≥ 4 thrombocytopenia; Grade ≥ 4 neutropenia lasting > 5 days or accompanied by fever; Fasting Grade ≥ 4 hyperglycemia or ≥ 3 hyperglycemia for ≥ 1 week; Grade ≥ 4 fasting hypercholesterolemia or triglyceridemia for ≥ 2 weeks; Grade ≥ 3 serum bilirubin or hepatic transaminase (ALT or AST); For participants abnormal at baseline: hepatic transaminase ≥ 7.5 × the upper limit of normal (ULN) or total bilirubin ≥ 5 × the ULN or 10 × the ULN or alkaline phosphatase ≥ 10 times the ULN. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Primary

End point timeframe

Baseline up to 35 days of Cycle 1

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 analyses have been specified for this endpoint
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 1: GDC-0032 5 mg QD	Phase I, Stage 1: GDC-0032 8 mg QD	Phase I, Stage 1: GDC-0032 12 mg QD	Phase I, Stage 1: GDC-0032 16 mg QD	Phase I, Stage 1: GDC-0032 3 mg QD
Number of subjects analysed	3	4	10	11	6
Units: percentage of participants
number (not applicable)	0.0	0.0	10.0	18.1	0.0

No statistical analyses for this end point

Primary: Phase I Stage 2 Cohorts E and F: Percentage of Participants with DLTs as Assessed by NCI CTCAE v4.0

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End point title

Phase I Stage 2 Cohorts E and F: Percentage of Participants with DLTs as Assessed by NCI CTCAE v4.0 ^[3] ^[4]

End point description

A DLT is defined as any one of the following toxicities occurring within the DLT Assessment Window (Days 1-28 of Cycle 1 in Stage 1) assessed by the investigator: Grade ≥ 3 non-hematologic, non-hepatic organ system, non-metabolic (hyperglycemia and hyperlipidemia) toxicity, excluding alopecia of any grade, Grade 3 diarrhea, Grade 3 nausea or vomiting; Grade ≥ 4 thrombocytopenia; Grade ≥ 4 neutropenia lasting > 5 days or accompanied by fever; Fasting Grade ≥ 4 hyperglycemia or ≥ 3 hyperglycemia for ≥ 1 week; Grade ≥ 4 fasting hypercholesterolemia or triglyceridemia for ≥ 2 weeks; Grade ≥ 3 serum bilirubin or hepatic transaminase (ALT or AST); For participants abnormal at baseline: hepatic transaminase ≥ 7.5 × ULN or total bilirubin ≥ 5 × the ULN or 10 × the ULN or alkaline phosphatase ≥ 10 times the ULN. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Primary

End point timeframe

Baseline up to 28 days of Cycle 1

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 analyses have been specified for this endpoint
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 2: Cohort E –GDC-0032 6 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort E -GDC-0032 9 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulv 500 mg
Number of subjects analysed	20	8	21	6
Units: percentage of participants
number (not applicable)	0.0	0.0	0.0	0.0

No statistical analyses for this end point

Primary: Phase I: AUC From Zero to tau (AUCtau) of GDC-0032

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End point title

Phase I: AUC From Zero to tau (AUCtau) of GDC-0032 ^[5] ^[6]

End point description

The concentrations are in micromole (µM), and the molecular weight of GDC-0032 is 460.53 g/mol. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant. 'n' signifies number of participants analysed for this outcome measure at the specified timepoint.

End point type

Primary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hr

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses have been specified for this endpoint
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 1: GDC-0032 3 milligrams (mg) once daily (QD)	Phase I, Stage 1: GDC-0032 5 mg QD	Phase I, Stage 1: GDC-0032 8 mg QD	Phase I, Stage 1: GDC-0032 12 mg QD	Phase I, Stage 1: GDC-0032 16 mg QD
Number of subjects analysed	6	3	4	10	11
Units: micromolar per hour (µM*h)
arithmetic mean (standard deviation)
Day 1 (n=6, 3, 4, 10, 11)	0.441 ( 0.142 )	0.547 ( 0.233 )	1.34 ( 0.411 )	1.8 ( 0.631 )	2.26 ( 0.806 )
Day 15 (n=6, 3, 3, 10, 9)	1.79 ( 0.962 )	1.49 ( 0.786 )	3.21 ( 1.636 )	5.1 ( 2.035 )	8.1 ( 4.790 )

No statistical analyses for this end point

Primary: Phase I: Maximum Observed Plasma Concentration (Cmax) of GDC-0032

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End point title

Phase I: Maximum Observed Plasma Concentration (Cmax) of GDC-0032 ^[7] ^[8]

End point description

The concentrations are in µM, and the molecular weight of GDC-0032 is 460.53 g/mol. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant. 'n' signifies number of participants analysed for this outcome measure at the specified timepoint.

End point type

Primary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hr

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses have been specified for this endpoint
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 1: GDC-0032 5 mg QD	Phase I, Stage 1: GDC-0032 8 mg QD	Phase I, Stage 1: GDC-0032 12 mg QD	Phase I, Stage 1: GDC-0032 16 mg QD	Phase I, Stage 1: GDC-0032 3 mg QD
Number of subjects analysed	3	4	10	11	6
Units: micromolar (µM)
arithmetic mean (standard deviation)
Day 1 (n=3, 4, 10, 11, 6)	0.0304 ( 0.0122 )	0.0764 ( 0.0328 )	0.127 ( 0.0529 )	0.134 ( 0.0535 )	0.0256 ( 0.0094 )
Day 15 (n=3, 3, 10, 9, 6)	0.091 ( 0.048 )	0.188 ( 0.119 )	0.302 ( 0.100 )	0.441 ( 0.251 )	0.111 ( 0.072 )

No statistical analyses for this end point

Primary: Phase I: Time to Reach Cmax (tmax) of GDC-0032

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End point title

Phase I: Time to Reach Cmax (tmax) of GDC-0032 ^[9] ^[10]

End point description

The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Primary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hr

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses have been specified for this endpoint
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 1: GDC-0032 5 mg QD	Phase I, Stage 1: GDC-0032 8 mg QD	Phase I, Stage 1: GDC-0032 12 mg QD	Phase I, Stage 1: GDC-0032 16 mg QD	Phase I, Stage 1: GDC-0032 3 mg QD
Number of subjects analysed	3	4	10	11	6
Units: hours (hr)
median (full range (min-max))	8 (3 to 8)	4 (2 to 4)	3 (1 to 8)	4 (2 to 24)	4 (3 to 8)

No statistical analyses for this end point

Primary: Phase I: Terminal Half-life (t1/2) of GDC-0032

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End point title

Phase I: Terminal Half-life (t1/2) of GDC-0032 ^[11] ^[12]

End point description

The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Primary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hr

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses have been specified for this endpoint
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 1: GDC-0032 5 mg QD	Phase I, Stage 1: GDC-0032 8 mg QD	Phase I, Stage 1: GDC-0032 12 mg QD	Phase I, Stage 1: GDC-0032 16 mg QD	Phase I, Stage 1: GDC-0032 3 mg QD
Number of subjects analysed	3	4	10	11	6
Units: hr
arithmetic mean (standard deviation)	40 ( 21.0 )	38.2 ( 9.1 )	36.7 ( 8.3 )	39.7 ( 8.0 )	43.8 ( 11.6 )

No statistical analyses for this end point

Primary: Across All Cohorts (Except Cohorts T and T2): Percentage of Participants With Best Overall Response (BOR) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

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End point title

Across All Cohorts (Except Cohorts T and T2): Percentage of Participants With Best Overall Response (BOR) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) ^[13]

End point description

BOR was defined as having best objective response as complete response (CR) or partial response (PR), as assessed by RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Primary

End point timeframe

Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)

Notes
[13] - 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 analyses have been specified for this endpoint

End point values	All Cohorts (Except T and T2)
Number of subjects analysed	674
Units: percentage of participants
number (confidence interval 95%)	11.4 (9.1 to 14.1)

No statistical analyses for this end point

Primary: Across All Cohorts (Except Cohorts T and T2): Duration of Objective Response (DOR) as Assessed Using RECIST v1.1

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End point title

Across All Cohorts (Except Cohorts T and T2): Duration of Objective Response (DOR) as Assessed Using RECIST v1.1 ^[14]

End point description

DOR was defined as time from first occurrence of a documented objective response(OR) to progressive disease(PD) or death from any cause(whichever occurred first) as determined by investigator according to RECIST v1.1. OR=CR+PR. CR: disappearance of all target lesions. PR: At least a 30% decrease in sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in absence of CR. PD: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to relative increase of 20%, sum of diameters must also demonstrate an absolute increase of >/= 5 mm. Safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant. ‘99999’ signifies data was not estimable due to insufficient number of responders and insufficient amount of time passed to measure DOR. ‘Number of subjects analyzed’ signifies number of responders.

End point type

Primary

End point timeframe

Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)

Notes
[14] - 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 analyses have been specified for this endpoint

End point values	All Cohorts (Except T and T2)
Number of subjects analysed	77
Units: months
median (confidence interval 95%)	99999 (-99999 to 99999)

No statistical analyses for this end point

Primary: Across All Cohorts (Except Cohorts T and T2): Progression-Free Survival (PFS) as Assessed Using RECIST v1.1

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End point title

Across All Cohorts (Except Cohorts T and T2): Progression-Free Survival (PFS) as Assessed Using RECIST v1.1 ^[15]

End point description

PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm). The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Primary

End point timeframe

Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)

Notes
[15] - 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 analyses have been specified for this endpoint

End point values	All Cohorts (Except T and T2)
Number of subjects analysed	674
Units: months
median (confidence interval 95%)	3.7 (3.6 to 4.2)

No statistical analyses for this end point

Primary: Percentage of Participants With BOR in Cohort T and T2

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End point title

Percentage of Participants With BOR in Cohort T and T2 ^[16]

End point description

BOR in Cohort T was assessed using the 2007 Revised International Working Group (IWG) Response Criteria in Malignant Lymphoma while in Cohort T2, BOR was assessed using the Modified Version of 2014 Lugano Response Criteria in Malignant Lymphoma. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Primary

End point timeframe

Baseline up to disease progression or death, whichever occurs first (up to a maximum of 46 months)

Notes
[16] - 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 analyses have been specified for this endpoint

End point values	Cohorts T and T2
Number of subjects analysed	20
Units: percentage of participants
number (confidence interval 95%)	20.0 (5.7 to 43.7)

No statistical analyses for this end point

Primary: DOR in Cohort T and T2

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End point title

DOR in Cohort T and T2 ^[17]

End point description

DOR in Cohort T was assessed using the 2007 Revised IWG Response Criteria in Malignant Lymphoma while in Cohort T2, it was assessed using the Modified Version of 2014 Lugano Response Criteria in Malignant Lymphoma. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant. '99999' signifies data was not estimable due to insufficient number of responders and insufficient amount of time passed to measure DOR. 'Number of subjects analyzed' signifies the number of responders.

End point type

Primary

End point timeframe

Baseline up to disease progression or death, whichever occurs first (up to a maximum of 46 months)

Notes
[17] - 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 analyses have been specified for this endpoint

End point values	Cohorts T and T2
Number of subjects analysed	4
Units: months
median (confidence interval 95%)	99999 (-99999 to 99999)

No statistical analyses for this end point

Primary: PFS in Cohort T and T2

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End point title

PFS in Cohort T and T2 ^[18]

End point description

PFS in Cohort T was assessed using the 2007 Revised IWG Response Criteria in Malignant Lymphoma while in Cohort T2, it was assessed using the Modified Version of 2014 Lugano Response Criteria in Malignant Lymphoma. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant. '99999' signifies upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with events.

End point type

Primary

End point timeframe

Baseline up to disease progression or death, whichever occurs first (up to a maximum of 46 months)

Notes
[18] - 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 analyses have been specified for this endpoint

End point values	Cohorts T and T2
Number of subjects analysed	20
Units: months
median (confidence interval 95%)	4.2 (1.8 to 99999)

No statistical analyses for this end point

Secondary: Phase I Stage 1: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by NCI CTCAE v4.0 grade

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End point title

Phase I Stage 1: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by NCI CTCAE v4.0 grade ^[19]

End point description

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. An SAE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s) or considered a significant medical event by the investigator. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Secondary

End point timeframe

From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to a maximum of 16 months)

Notes
[19] - 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: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 1: GDC-0032 5 mg QD	Phase I, Stage 1: GDC-0032 8 mg QD	Phase I, Stage 1: GDC-0032 12 mg QD	Phase I, Stage 1: GDC-0032 16 mg QD	Phase I, Stage 1: GDC-0032 3 mg QD
Number of subjects analysed	3	4	10	11	6
Units: percentage of participants
number (not applicable)
AEs	100.0	100.0	100.0	100.0	100.0
SAEs	0	50.0	40.0	81.8	16.7

No statistical analyses for this end point

Secondary: Phase I Stage 2: Percentage of Participants with AEs and SAEs by NCI CTCAE v4.0 grade

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End point title

Phase I Stage 2: Percentage of Participants with AEs and SAEs by NCI CTCAE v4.0 grade ^[20]

End point description

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP or other protocol-imposed intervention, regardless of attribution. An SAE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s) or considered a significant medical event by the investigator. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Secondary

End point timeframe

From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to a maximum of 67 months)

Notes
[20] - 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: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort C -GDC-0032 9 mg QD + Mida 5 mg	Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort E –GDC-0032 6 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort E -GDC-0032 9 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD	Phase I, Stage 2: Cohort J - GDC-0032 4 mg + Fulv 500 mg	Phase I, Stage 2: Cohort K - GDC-0032 4 mg + Fulv 500 mg	Phase I, Stage 2: Cohort L - GDC-0032 4 mg + Fulv 500 mg	Phase I, Stage 2: Cohort M - GDC-0032 2 mg QD + Fulv 500 mg	Phase I, Stage 2: Cohort N -GDC-0032 2 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort P -GDC-0032 4 mg QD + Letro 2.5 mg QD	Phase I, Stage 2: Cohort Q - GDC-0032 4 mg + Letro 2.5 mg QD	Phase I, Stage 2: Cohort R - GDC-0032 4 mg + Letro 2.5 mg QD	Phase I, Stage 2: Cohort S - GDC-0032 4 mg + Letro 2.5 mg QD	Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Number of subjects analysed	20	20	13	10	20	8	21	6	21	35	20	20	19	20	27	28	20	20	20	10	10	70	122
Units: percentage of participants
number (not applicable)
AEs	100.0	100.0	92.3	100.0	100.0	87.5	100.0	100.0	100.0	100.0	95.0	95.0	100.0	100.0	100.0	96.4	100.0	100.0	95.0	100.0	100.0	100.0	99.2
SAEs	45.0	35.0	53.8	40.0	55.0	25.0	23.8	50.0	42.9	54.3	20.0	35.0	15.8	30.0	22.2	35.7	10.0	25.0	10.0	70.0	40.0	57.1	51.6

No statistical analyses for this end point

Secondary: Phase II: Percentage of Participants with AEs and SAEs by NCI CTCAE v4.0 grade

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End point title

Phase II: Percentage of Participants with AEs and SAEs by NCI CTCAE v4.0 grade ^[21]

End point description

End point type

Secondary

End point timeframe

From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to a maximum of 54 months)

Notes
[21] - 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: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase II: GDC-0032 6 mg QD + Fulv 500 mg
Number of subjects analysed	60
Units: percentage of participants
number (not applicable)
AEs	100.0
SAEs	31.7

No statistical analyses for this end point

Secondary: Percentage of Participants with Clinical Relevant Shifts from Baseline in Laboratory Parameters

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End point title

Percentage of Participants with Clinical Relevant Shifts from Baseline in Laboratory Parameters

End point description

Laboratory parameters such as fasting glucose, absolute neutrophil count, hemoglobin, platelet count, lymphocytes, serum creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT), leukocytes, fasting triglycerides and fasting cholesterol were assessed. A clinical relevant shift from baseline was defined as a shift from Grade 0, 1, or 2 at baseline to Grade 3 or 4 post baseline. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Secondary

End point timeframe

Baseline to a maximum of 67 months

End point values	GDC-0032 Monotherapy	GDC-0032 + Letrozole	GDC-0032 + Fulvestrant
Number of subjects analysed	365	143	166
Units: percentage of participants
number (not applicable)
High Fasting Glucose	9.3	4.9	3.0
Low Fasting Glucose	0	0	0
Low Absolute Neutrophil Count	4.8	0	0.7
High Hemoglobin	0	0	0
Low Hemoglobin	5.2	0.7	1.2
Low Platelet Count	1.5	0.7	0.6
High Lymphocytes	0	0.9	0
Low Lymphocytes	13.9	7.3	2.9
High Serum Creatinine	0.9	0	2.5
High AST	2.6	6.3	7.0
High ALT	2.0	4.2	5.2
High Leukocytes	0	0	0
Low Leukocytes	2.1	1.4	0
High Fasting Triglycerides	0.4	0.9	0.8
High Fasting Cholesterol	0	0	0

No statistical analyses for this end point

Secondary: Cmax of GDC-0032 Under Fed Conditions

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End point title

Cmax of GDC-0032 Under Fed Conditions ^[22]

End point description

For dosing under fed conditions, participant fasted overnight for >/= 10 hours before the standard high-fat meal provided at the study site. Participants started the standard high fat meal 30 minutes prior to administration of GDC-0032. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Secondary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hr), 1, 2, 3, 4, 8, and 24 hr; Day 8: Pre-dose (0-2 hr), 1, 2, 3, 4, 8 and 24 hr

Notes
[22] - 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: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
Number of subjects analysed	20
Units: µM
arithmetic mean (standard deviation)	0.082 ( 0.038 )

No statistical analyses for this end point

Secondary: AUC of GDC-0032 Under Fed Conditions

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End point title

AUC of GDC-0032 Under Fed Conditions ^[23]

End point description

End point type

Secondary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hr), 1, 2, 3, 4, 8, and 24 hr; Day 8: Pre-dose (0-2 hr), 1, 2, 3, 4, 8 and 24 hr

Notes
[23] - 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: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
Number of subjects analysed	20
Units: µM*hr
arithmetic mean (standard deviation)	1.404 ( 0.656 )

No statistical analyses for this end point

Secondary: Cmax of GDC-0032 Under Fasted Conditions

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End point title

Cmax of GDC-0032 Under Fasted Conditions ^[24]

End point description

Participants fasted overnight for at least 10 hours before dosing and 4 hours postdose. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Secondary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hr), 1, 2, 3, 4, 8, and 24 hr; Day 8: Pre-dose (0-2 hr), 1, 2, 3, 4, 8 and 24 hr

Notes
[24] - 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: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
Number of subjects analysed	20
Units: µM
arithmetic mean (standard deviation)	0.085 ( 0.046 )

No statistical analyses for this end point

Secondary: AUC of GDC-0032 Under Fasted Conditions

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End point title

AUC of GDC-0032 Under Fasted Conditions ^[25]

End point description

End point type

Secondary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hr), 1, 2, 3, 4, 8, and 24 hr; Day 8: Pre-dose (0-2 hr), 1, 2, 3, 4, 8 and 24 hr

Notes
[25] - 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: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD
Number of subjects analysed	20
Units: µM*hr
arithmetic mean (standard deviation)	1.247 ( 0.911 )

No statistical analyses for this end point

Secondary: Geometric Mean Ratio of Cmax for Midazolam plus GDC-0032 Relative to Cmax for Midazolam Alone

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End point title

Geometric Mean Ratio of Cmax for Midazolam plus GDC-0032 Relative to Cmax for Midazolam Alone ^[26]

End point description

The geometric mean ratio (90% CI) for midazolam+ GDC-0032 relative to midazolam alone was reported. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Secondary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hr), 0.5, 1, 1.5, 2, 4, 8, 24 hr; Day 16: Pre-dose (0-2 hr), 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hr

Notes
[26] - 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: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 2: Cohort C -GDC-0032 9 mg QD + Mida 5 mg
Number of subjects analysed	13
Units: geometric mean ratio
number (confidence interval 90%)	0.98 (0.70 to 1.37)

No statistical analyses for this end point

Secondary: Geometric Mean Ratio of AUC for Midazolam plus GDC-0032 Relative to AUC for Midazolam Alone

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End point title

Geometric Mean Ratio of AUC for Midazolam plus GDC-0032 Relative to AUC for Midazolam Alone ^[27]

End point description

The geometric mean ratios (90% CIs) for midazolam + GDC-0032 relative to midazolam alone were reported. The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

End point type

Secondary

End point timeframe

Cycle 1, Day 1: Pre-dose (0-2 hr), 0.5, 1, 1.5, 2, 4, 8, 24 hr; Day 16: Pre-dose (0-2 hr), 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hr

Notes
[27] - 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: The data for this endpoint was collected for the participants in Phase 1 Stage 1 only

End point values	Phase I, Stage 2: Cohort C -GDC-0032 9 mg QD + Mida 5 mg
Number of subjects analysed	13
Units: geometric mean ratio
number (confidence interval 90%)	1.04 (0.68 to 1.60)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From first dose up to 30 days after the last dose of study drug or study discontinuation/termination (Up to approximately 68 months)

Adverse event reporting additional description

The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Phase I,Stage 1: GDC-0032 3 milligrams(mg) once daily(QD)

Reporting group description

Participants received GDC-0032 3 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 5 mg QD

Reporting group description

Participants received GDC-0032 5 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 16 mg QD

Reporting group description

Participants received GDC 0032 16 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28- day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 8 mg QD

Reporting group description

Participants received GDC-0032 8 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 1: GDC-0032 12 mg QD

Reporting group description

Participants received GDC 0032 12 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD

Reporting group description

Participants with PIK3CA mutant solid tumors other than breast cancer were enrolled in this cohort to receive GDC 0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD

Reporting group description

Participants with PIK3CA mutant breast cancer were enrolled in this cohort to receive GDC 0032 9 mg capsules, orally, once on Day 1 and then QD on Days 8 to 35 of Cycle 1 (Cycle 1 duration=35 days) and in subsequent 28- day cycles until disease progression.

Reporting group title

Phase I,Stage 2:Cohort C- GDC-0032 9 mg QD+Midazolam 5 mg

Reporting group description

Participants with any type of solid tumors were enrolled in this cohort to receive GDC 0032 9 mg capsules, orally, QD on Days 2 to 29 along with midazolam 5 mg syrup, orally, once on Days 1 and 16 of Cycle 1 (Cycle 1 duration=29 days) followed by GDC-0032 9 mg capsules, orally, QD in subsequent 28- day cycles until disease progression.

Reporting group title

Phase I,Stage 2: Cohort E-GDC-0032 6mg QD+Letrozole 2.5mg QD

Reporting group description

Postmenopausal participants with hormone receptor-positive breast cancer were enrolled in this cohort to receive GDC 0032 6 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD

Reporting group description

Participants with HER2- positive breast cancer were enrolled in this cohort to receive GDC 0032 9 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I,Stage 2: Cohort E-GDC-0032 9mg QD+Letrozole 2.5mg QD

Reporting group description

Postmenop ausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I,Stage 2:Cohort F-GDC-0032 6mg QD+Fulvestrant 500mg

Reporting group description

Postmenop ausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 6 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, intramuscul arly (IM) on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28- day cycle until disease progression.

Reporting group title

Phase I, Stage 2: Cohort J-GDC-0032 4mg+Fulvestrant 500mg

Reporting group description

Postmenopausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 of each 28- day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28- day cycle until disease progression .

Reporting group title

Phase I,Stage 2:Cohort F-GDC-0032 9mg QD+Fulvestrant 500mg

Reporting group description

Postmenopausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 9 mg capsules, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28- day cycle until disease progression.

Reporting group title

Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD

Reporting group description

Participa nts with solid tumors with increase d PIK3CA copy number were enrolled in this cohort to receive GDC 0032 9 mg capsules , orally, QD in each 28- day cycle until disease progress ion

Reporting group title

Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD

Reporting group description

Participants with PIK3CA mutant solid tumors that are non breast and non colorect al cancer were enrolled in this cohort to receive GDC 0032 6 mg tablets, orally, QD on Days 1 to 21 of each 28- day cycle until disease progress ion.

Reporting group title

Phase I,Stage 2: Cohort L-GDC-0032 4mg + Fulvestrant 500mg

Reporting group description

Postmenopausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1- 7 and 15-21 of each 28- day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28- day cycle until disease progression.

Reporting group title

Phase I,Stage 2: Cohort M-GDC-0032 2mg QD+Fulvestrant 500mg

Reporting group description

Postmenopausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets, orally, QD in each 28- day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28- day cycle until disease progression.

Reporting group title

Phase I,Stage 2:Cohort N-GDC-0032 2mg QD+Letrozole 2.5mg QD

Reporting group description

Postmenopausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 2 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I,Stage 2:Cohort K-GDC-0032 4mg+Fulvestrant 500mg

Reporting group description

Postmenopausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1- 5, 8-12, 15- 19, and 22- 26 of each 28-day cycle along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28- day cycle until disease progression.

Reporting group title

Phase I,Stage 2:Cohort R-GDC-0032 4mg+Letrozole 2.5mg QD

Reporting group description

Postmenopausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally on Days 1-5, 8-12, 15- 19, and 22- 26 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I,Stage 2:Cohort P-GDC-0032 4mg QD+Letrozole 2.5mg QD

Reporting group description

Postmenopausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets and letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I,Stage 2:Cohort Q-GDC-0032 4mg+Letrozole 2.5mg QD

Reporting group description

Postmenopausal participants with hormone receptor positive breast cancer were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD on Days 1 to 21 along with letrozole 2.5 mg capsules, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I,Stage 2:Cohort S-GDC-0032 4mg+Letrozole 2.5mg QD

Reporting group description

Reporting group title

Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD

Reporting group description

Participants with non Hodgkin’s lymphoma that had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC 0032 4 mg tablets, orally QD in 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD

Reporting group description

Participants with DLBCL who had progressed or had failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC 0032 4 mg tablets, orally, QD in 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD

Reporting group description

Participants with PIK3CA mutant solid tumors that have progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 4 mg tablets, orally, QD in 28- day cycles until disease progression.

Reporting group title

Phase II: GDC-0032 6 mg QD + Fulvestrant 500 mg

Reporting group description

Postmenopausal participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer who had not previously received fulvestrant were enrolled in this cohort to receive GDC 0032 6 mg tablets, orally, QD in 28-day cycles along with fulvestrant 500 mg, IM on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycles until disease progression.

Reporting group title

Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD

Reporting group description

Participants with PIK3CA mutant solid tumors that had progressed or failed to respond to at least one prior regimen were enrolled in this cohort to receive GDC-0032 6 mg tablets, orally QD in 28- day cycles until disease progression.

Phase I,Stage 1: GDC-0032 3 milligrams(mg) once daily(QD)

Phase I, Stage 1: GDC-0032 5 mg QD

Phase I, Stage 1: GDC-0032 16 mg QD

Phase I, Stage 1: GDC-0032 8 mg QD

Phase I, Stage 1: GDC-0032 12 mg QD

Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD

Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD

Phase I,Stage 2:Cohort C- GDC-0032 9 mg QD+Midazolam 5 mg

Phase I,Stage 2: Cohort E-GDC-0032 6mg QD+Letrozole 2.5mg QD

Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD

Phase I,Stage 2: Cohort E-GDC-0032 9mg QD+Letrozole 2.5mg QD

Phase I,Stage 2:Cohort F-GDC-0032 6mg QD+Fulvestrant 500mg

Phase I, Stage 2: Cohort J-GDC-0032 4mg+Fulvestrant 500mg

Phase I,Stage 2:Cohort F-GDC-0032 9mg QD+Fulvestrant 500mg

Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD

Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD

Phase I,Stage 2: Cohort L-GDC-0032 4mg + Fulvestrant 500mg

Phase I,Stage 2: Cohort M-GDC-0032 2mg QD+Fulvestrant 500mg

Phase I,Stage 2:Cohort N-GDC-0032 2mg QD+Letrozole 2.5mg QD

Phase I,Stage 2:Cohort K-GDC-0032 4mg+Fulvestrant 500mg

Phase I,Stage 2:Cohort R-GDC-0032 4mg+Letrozole 2.5mg QD

Phase I,Stage 2:Cohort P-GDC-0032 4mg QD+Letrozole 2.5mg QD

Phase I,Stage 2:Cohort Q-GDC-0032 4mg+Letrozole 2.5mg QD

Phase I,Stage 2:Cohort S-GDC-0032 4mg+Letrozole 2.5mg QD

Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD

Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD

Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD

Phase II: GDC-0032 6 mg QD + Fulvestrant 500 mg

Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 6 (16.67%)

0 / 3 (0.00%)

9 / 11 (81.82%)

2 / 4 (50.00%)

4 / 10 (40.00%)

7 / 20 (35.00%)

9 / 20 (45.00%)

7 / 13 (53.85%)

11 / 20 (55.00%)

4 / 10 (40.00%)

2 / 8 (25.00%)

5 / 21 (23.81%)

4 / 20 (20.00%)

3 / 6 (50.00%)

9 / 21 (42.86%)

19 / 35 (54.29%)

3 / 19 (15.79%)

6 / 20 (30.00%)

6 / 27 (22.22%)

7 / 20 (35.00%)

5 / 20 (25.00%)

10 / 28 (35.71%)

2 / 20 (10.00%)

7 / 10 (70.00%)

4 / 10 (40.00%)

40 / 70 (57.14%)

19 / 60 (31.67%)

63 / 122 (51.64%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

MALIGNANT PLEURAL EFFUSION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 13 (7.69%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

HYPOTENSION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

2 / 122 (1.64%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

ARTERIAL RUPTURE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

DEEP VEIN THROMBOSIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPERTENSION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

LYMPHOEDEMA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SHOCK HAEMORRHAGIC

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

VENOUS THROMBOSIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (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

DEATH

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

ASTHENIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FATIGUE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

1 / 11 (9.09%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

MUCOSAL INFLAMMATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PAIN

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PYREXIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

2 / 28 (7.14%)

1 / 20 (5.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

2 / 70 (2.86%)

0 / 60 (0.00%)

2 / 122 (1.64%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

0 / 3

0 / 0

0 / 2

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

SOFT TISSUE INFLAMMATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

SUDDEN DEATH

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

Immune system disorders

HYPERSENSITIVITY

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

FEMALE GENITAL TRACT FISTULA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

OVARIAN CYST RUPTURED

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

PROSTATITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 10 (10.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

PNEUMONIA ASPIRATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

PULMONARY EMBOLISM

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

3 / 122 (2.46%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 3

deaths causally related to treatment / all

0 / 0

ACUTE RESPIRATORY DISTRESS SYNDROME

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ACUTE RESPIRATORY FAILURE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

2 / 70 (2.86%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

ANOXIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ASTHMA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

ATELECTASIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

COUGH

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DYSPNOEA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

2 / 35 (5.71%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

3 / 70 (4.29%)

0 / 60 (0.00%)

5 / 122 (4.10%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 2

0 / 1

0 / 0

0 / 3

0 / 0

0 / 6

deaths causally related to treatment / all

0 / 0

HAEMOPTYSIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

HYPOXIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

2 / 70 (2.86%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

LARYNGEAL HAEMORRHAGE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

LUNG INFILTRATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PLEURAL EFFUSION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

2 / 20 (10.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

1 / 60 (1.67%)

2 / 122 (1.64%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

1 / 1

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

deaths causally related to treatment / all

0 / 0

PNEUMONITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

1 / 11 (9.09%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

1 / 13 (7.69%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

2 / 21 (9.52%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

2 / 122 (1.64%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

2 / 2

0 / 0

2 / 2

0 / 0

1 / 1

0 / 0

2 / 2

deaths causally related to treatment / all

0 / 0

PNEUMOTHORAX

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

2 / 35 (5.71%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

PULMONARY OEDEMA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

PULMONARY TOXICITY

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

RESPIRATORY FAILURE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Psychiatric disorders

MENTAL STATUS CHANGES

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Investigations

AMYLASE INCREASED

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BLOOD CREATININE INCREASED

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

LIPASE INCREASED

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TRANSAMINASES INCREASED

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

FALL

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FEMUR FRACTURE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

RIB FRACTURE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

OVERDOSE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

TIBIA FRACTURE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TRACHEAL HAEMORRHAGE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

VASCULAR PSEUDOANEURYSM

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Cardiac disorders

CARDIAC ARREST

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (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

ATRIAL FIBRILLATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

2 / 122 (1.64%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

CARDIAC FAILURE CONGESTIVE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

1 / 10 (10.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

CARDIO-RESPIRATORY ARREST

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

MITRAL VALVE DISEASE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PERICARDIAL EFFUSION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

STRESS CARDIOMYOPATHY

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SUPRAVENTRICULAR TACHYCARDIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VENTRICULAR ARRHYTHMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VENTRICULAR TACHYARRHYTHMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

VENTRICULAR TACHYCARDIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Nervous system disorders

CENTRAL NERVOUS SYSTEM LESION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 10 (10.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HEADACHE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SEIZURE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SYNCOPE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ATAXIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

2 / 35 (5.71%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

BRAIN OEDEMA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DIZZINESS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ENCEPHALOPATHY

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 10 (10.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

EPILEPSY

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

1 / 6 (16.67%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FACIAL NERVE DISORDER

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

1 / 11 (9.09%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

LETHARGY

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

ANAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FEBRILE NEUTROPENIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

NEUTROPENIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Eye disorders

PAPILLOEDEMA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

COLITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

1 / 10 (10.00%)

1 / 20 (5.00%)

2 / 20 (10.00%)

1 / 13 (7.69%)

0 / 20 (0.00%)

2 / 10 (20.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

1 / 20 (5.00%)

1 / 6 (16.67%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

1 / 27 (3.70%)

2 / 20 (10.00%)

0 / 20 (0.00%)

2 / 28 (7.14%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

2 / 70 (2.86%)

6 / 60 (10.00%)

7 / 122 (5.74%)

occurrences causally related to treatment / all

0 / 0

1 / 1

2 / 2

1 / 1

0 / 0

3 / 3

0 / 0

1 / 1

0 / 0

1 / 1

3 / 3

0 / 0

2 / 2

0 / 0

0 / 1

0 / 0

1 / 2

6 / 6

7 / 7

deaths causally related to treatment / all

0 / 0

CONSTIPATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

GASTROINTESTINAL HAEMORRHAGE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

GASTROINTESTINAL VASCULAR MALFORMATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

RECTAL HAEMORRHAGE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

ABDOMINAL PAIN

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

1 / 13 (7.69%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

2 / 70 (2.86%)

0 / 60 (0.00%)

5 / 122 (4.10%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 5

deaths causally related to treatment / all

0 / 0

ASCITES

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

COLITIS MICROSCOPIC

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

CROHN'S DISEASE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DIARRHOEA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

2 / 11 (18.18%)

0 / 4 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 8 (12.50%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

3 / 28 (10.71%)

0 / 20 (0.00%)

1 / 20 (5.00%)

3 / 10 (30.00%)

0 / 10 (0.00%)

3 / 70 (4.29%)

1 / 60 (1.67%)

7 / 122 (5.74%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

1 / 1

0 / 0

1 / 1

2 / 2

0 / 0

0 / 1

0 / 0

4 / 4

0 / 0

1 / 1

4 / 4

0 / 0

3 / 3

1 / 1

7 / 7

deaths causally related to treatment / all

0 / 0

DUODENAL PERFORATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DYSPHAGIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ENTERITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

2 / 122 (1.64%)

occurrences causally related to treatment / all

0 / 0

2 / 2

deaths causally related to treatment / all

0 / 0

ENTEROCOLITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

1 / 60 (1.67%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

1 / 1

deaths causally related to treatment / all

0 / 0

GASTRITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

GASTROINTESTINAL FISTULA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

GASTROINTESTINAL NECROSIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HAEMATEMESIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

JEJUNAL PERFORATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

LARGE INTESTINAL STENOSIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

NARCOTIC BOWEL SYNDROME

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

NAUSEA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

2 / 70 (2.86%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

1 / 2

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

NEUTROPENIC COLITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PEPTIC ULCER PERFORATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SMALL INTESTINAL OBSTRUCTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

STOMATITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 8 (12.50%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

SUBILEUS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

UPPER GASTROINTESTINAL HAEMORRHAGE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VOMITING

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

1 / 6 (16.67%)

1 / 21 (4.76%)

2 / 35 (5.71%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

2 / 70 (2.86%)

0 / 60 (0.00%)

4 / 122 (3.28%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 2

0 / 0

1 / 1

0 / 0

1 / 2

0 / 0

1 / 6

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

CHOLELITHIASIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BILIARY OBSTRUCTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CHOLANGITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

CHOLECYSTITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

HEPATIC FAILURE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

JAUNDICE CHOLESTATIC

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

1 / 4 (25.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PORTAL HYPERTENSION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

EXFOLIATIVE RASH

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

1 / 11 (9.09%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PAIN OF SKIN

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

RASH

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

RASH MACULO-PAPULAR

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

RASH PRURITIC

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

ACUTE KIDNEY INJURY

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 10 (10.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

RENAL FAILURE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

URETERIC DILATATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

URETHRAL OBSTRUCTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 13 (7.69%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

URINARY TRACT OBSTRUCTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

ARTHRALGIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BACK PAIN

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 13 (7.69%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

1 / 20 (5.00%)

2 / 28 (7.14%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BONE PAIN

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

FLANK PAIN

subjects affected / exposed

1 / 6 (16.67%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

MUSCULAR WEAKNESS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PAIN IN EXTREMITY

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

APPENDICITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CELLULITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

DIVERTICULITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

PNEUMONIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

1 / 11 (9.09%)

1 / 4 (25.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 13 (7.69%)

1 / 20 (5.00%)

1 / 10 (10.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

2 / 70 (2.86%)

3 / 60 (5.00%)

5 / 122 (4.10%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 1

0 / 0

0 / 1

1 / 1

0 / 0

0 / 1

0 / 0

2 / 3

0 / 5

1 / 7

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 1

PYELONEPHRITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

URINARY TRACT INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

2 / 20 (10.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

UROSEPSIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

1 / 6 (16.67%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ABDOMINAL INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

2 / 122 (1.64%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

ABDOMINAL WALL ABSCESS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BACTERAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

2 / 10 (20.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

BRAIN ABSCESS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

BRONCHITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

CHEST WALL ABSCESS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CLOSTRIDIUM DIFFICILE COLITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CLOSTRIDIUM DIFFICILE INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

DENGUE FEVER

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DEVICE RELATED INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

ENDOCARDITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

ENTEROBACTER INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

GASTRIC INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

GASTROENTERITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

KLEBSIELLA INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

LOCALISED INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PAROTITIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

PERITONITIS BACTERIAL

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PSEUDOMONAS INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

RESPIRATORY SYNCYTIAL VIRUS INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

1 / 11 (9.09%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

RESPIRATORY TRACT INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

SEPSIS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 3

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

SEPTIC SHOCK

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

1 / 10 (10.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

1 / 1

STAPHYLOCOCCAL BACTERAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

STREPTOCOCCAL BACTERAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TOOTH ABSCESS

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VARICELLA ZOSTER VIRUS INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VASCULAR DEVICE INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

WOUND INFECTION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

1 / 6 (16.67%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

DEHYDRATION

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 13 (0.00%)

1 / 20 (5.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 27 (3.70%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

DECREASED APPETITE

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

HYPERCALCAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

1 / 70 (1.43%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

HYPERGLYCAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

2 / 11 (18.18%)

0 / 4 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

2 / 35 (5.71%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

1 / 28 (3.57%)

0 / 20 (0.00%)

0 / 10 (0.00%)

2 / 70 (2.86%)

1 / 60 (1.67%)

4 / 122 (3.28%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

1 / 1

0 / 0

1 / 1

2 / 2

0 / 0

1 / 1

0 / 0

2 / 2

0 / 1

4 / 4

deaths causally related to treatment / all

0 / 0

HYPERKALAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPOKALAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

1 / 122 (0.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

HYPOMAGNESAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPONATRAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 13 (7.69%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

1 / 60 (1.67%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPOVOLAEMIA

subjects affected / exposed

0 / 6 (0.00%)

0 / 3 (0.00%)

0 / 11 (0.00%)

0 / 4 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 13 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 8 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 27 (0.00%)

0 / 20 (0.00%)

0 / 28 (0.00%)

0 / 20 (0.00%)

0 / 10 (0.00%)

0 / 70 (0.00%)

0 / 60 (0.00%)

0 / 122 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Phase I,Stage 1: GDC-0032 3 milligrams(mg) once daily(QD)	Phase I, Stage 1: GDC-0032 5 mg QD	Phase I, Stage 1: GDC-0032 16 mg QD	Phase I, Stage 1: GDC-0032 8 mg QD	Phase I, Stage 1: GDC-0032 12 mg QD	Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD	Phase I,Stage 2:Cohort C- GDC-0032 9 mg QD+Midazolam 5 mg	Phase I,Stage 2: Cohort E-GDC-0032 6mg QD+Letrozole 2.5mg QD	Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD	Phase I,Stage 2: Cohort E-GDC-0032 9mg QD+Letrozole 2.5mg QD	Phase I,Stage 2:Cohort F-GDC-0032 6mg QD+Fulvestrant 500mg	Phase I, Stage 2: Cohort J-GDC-0032 4mg+Fulvestrant 500mg	Phase I,Stage 2:Cohort F-GDC-0032 9mg QD+Fulvestrant 500mg	Phase I, Stage 2: Cohort G - GDC-0032 9 mg QD	Phase I, Stage 2: Cohort H - GDC-0032 6 mg QD	Phase I,Stage 2: Cohort L-GDC-0032 4mg + Fulvestrant 500mg	Phase I,Stage 2: Cohort M-GDC-0032 2mg QD+Fulvestrant 500mg	Phase I,Stage 2:Cohort N-GDC-0032 2mg QD+Letrozole 2.5mg QD	Phase I,Stage 2:Cohort K-GDC-0032 4mg+Fulvestrant 500mg	Phase I,Stage 2:Cohort R-GDC-0032 4mg+Letrozole 2.5mg QD	Phase I,Stage 2:Cohort P-GDC-0032 4mg QD+Letrozole 2.5mg QD	Phase I,Stage 2:Cohort Q-GDC-0032 4mg+Letrozole 2.5mg QD	Phase I,Stage 2:Cohort S-GDC-0032 4mg+Letrozole 2.5mg QD	Phase I, Stage 2: Cohort T - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort T2 - GDC-0032 4 mg QD	Phase I, Stage 2: Cohort X - GDC-0032 4 mg QD	Phase II: GDC-0032 6 mg QD + Fulvestrant 500 mg	Phase I, Stage 2: Cohort X - GDC-0032 6 mg QD
Total subjects affected by non serious adverse events
subjects affected / exposed	6 / 6 (100.00%)	3 / 3 (100.00%)	11 / 11 (100.00%)	4 / 4 (100.00%)	10 / 10 (100.00%)	19 / 20 (95.00%)	20 / 20 (100.00%)	12 / 13 (92.31%)	20 / 20 (100.00%)	10 / 10 (100.00%)	7 / 8 (87.50%)	21 / 21 (100.00%)	19 / 20 (95.00%)	6 / 6 (100.00%)	21 / 21 (100.00%)	35 / 35 (100.00%)	19 / 19 (100.00%)	20 / 20 (100.00%)	27 / 27 (100.00%)	19 / 20 (95.00%)	20 / 20 (100.00%)	27 / 28 (96.43%)	20 / 20 (100.00%)	19 / 20 (95.00%)	10 / 10 (100.00%)	10 / 10 (100.00%)	69 / 70 (98.57%)	60 / 60 (100.00%)	117 / 122 (95.90%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
BRAIN NEOPLASM
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
HAEMANGIOMA OF SKIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
LIP NEOPLASM
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PAPILLOMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
TUMOUR FISTULISATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
TUMOUR PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	2 / 10 (20.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	2	0	1
Vascular disorders
HYPERTENSION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 19 (15.79%)	1 / 20 (5.00%)	4 / 27 (14.81%)	1 / 20 (5.00%)	1 / 20 (5.00%)	4 / 28 (14.29%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	2 / 60 (3.33%)	5 / 122 (4.10%)
occurrences all number	0	0	0	0	0	6	0	0	1	0	0	2	0	1	1	2	4	1	4	1	1	5	1	1	0	0	2	2	6
DEEP VEIN THROMBOSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	2	0	1	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	2	1	1
EMBOLISM VENOUS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
FLUSHING
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	1	1	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1
HAEMATOMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
HOT FLUSH
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 19 (15.79%)	0 / 20 (0.00%)	6 / 27 (22.22%)	2 / 20 (10.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	4 / 20 (20.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	4 / 60 (6.67%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	1	2	0	0	0	0	3	0	6	2	0	2	4	3	0	0	0	4	1
HYPOTENSION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	4 / 70 (5.71%)	0 / 60 (0.00%)	6 / 122 (4.92%)
occurrences all number	0	0	1	1	0	0	0	1	1	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	6	0	7
JUGULAR VEIN THROMBOSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
LYMPHOEDEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	1	3	0	0	1	1	0	0	1	0	0	1	0	0	0	3	0	0
General disorders and administration site conditions
ASTHENIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	3 / 20 (15.00%)	2 / 20 (10.00%)	1 / 13 (7.69%)	5 / 20 (25.00%)	0 / 10 (0.00%)	3 / 8 (37.50%)	6 / 21 (28.57%)	4 / 20 (20.00%)	2 / 6 (33.33%)	5 / 21 (23.81%)	2 / 35 (5.71%)	1 / 19 (5.26%)	4 / 20 (20.00%)	2 / 27 (7.41%)	2 / 20 (10.00%)	5 / 20 (25.00%)	3 / 28 (10.71%)	4 / 20 (20.00%)	3 / 20 (15.00%)	6 / 10 (60.00%)	2 / 10 (20.00%)	8 / 70 (11.43%)	12 / 60 (20.00%)	12 / 122 (9.84%)
occurrences all number	0	0	0	0	0	6	4	1	9	0	4	11	8	4	8	2	1	5	2	2	7	6	7	4	12	2	22	18	15
AXILLARY PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	2 / 19 (10.53%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	1	0	0	0	0	0
CATHETER SITE ERYTHEMA
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
CATHETER SITE INFLAMMATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
CATHETER SITE OEDEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
CATHETER SITE RASH
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
CHEST DISCOMFORT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	2 / 20 (10.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	2 / 60 (3.33%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	1	0	0	0	1	2	1	0	0	0	0	0	0	0	0	2	0
CHEST PAIN
subjects affected / exposed	1 / 6 (16.67%)	1 / 3 (33.33%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	4 / 60 (6.67%)	2 / 122 (1.64%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	1	0	1	0	2	1	0	0	5	0	1	1	0	1	0	0	4	2
CHILLS
subjects affected / exposed	0 / 6 (0.00%)	2 / 3 (66.67%)	0 / 11 (0.00%)	1 / 4 (25.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	3 / 20 (15.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 28 (0.00%)	2 / 20 (10.00%)	2 / 20 (10.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	5 / 70 (7.14%)	1 / 60 (1.67%)	6 / 122 (4.92%)
occurrences all number	0	2	0	1	2	0	0	1	3	2	0	1	1	0	0	1	1	1	0	0	2	0	2	2	1	0	8	1	7
DEVICE RELATED THROMBOSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
EARLY SATIETY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	2 / 122 (1.64%)
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	1	0	2
FATIGUE
subjects affected / exposed	2 / 6 (33.33%)	1 / 3 (33.33%)	8 / 11 (72.73%)	2 / 4 (50.00%)	6 / 10 (60.00%)	5 / 20 (25.00%)	12 / 20 (60.00%)	10 / 13 (76.92%)	9 / 20 (45.00%)	5 / 10 (50.00%)	2 / 8 (25.00%)	9 / 21 (42.86%)	8 / 20 (40.00%)	1 / 6 (16.67%)	6 / 21 (28.57%)	9 / 35 (25.71%)	7 / 19 (36.84%)	6 / 20 (30.00%)	11 / 27 (40.74%)	7 / 20 (35.00%)	8 / 20 (40.00%)	8 / 28 (28.57%)	7 / 20 (35.00%)	7 / 20 (35.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	25 / 70 (35.71%)	25 / 60 (41.67%)	40 / 122 (32.79%)
occurrences all number	2	1	16	3	8	7	18	13	15	5	2	20	18	1	12	12	12	11	15	10	9	18	9	12	0	1	40	39	59
GAIT DISTURBANCE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 35 (5.71%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	2	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	1	0
GENERAL PHYSICAL HEALTH DETERIORATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
GENERALISED OEDEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
INFLUENZA LIKE ILLNESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	1	0	0	0	1	0	0	0	0	2
INJECTION SITE ERYTHEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0
INJECTION SITE PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	4 / 60 (6.67%)	0 / 122 (0.00%)
occurrences all number	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	4	0
INJECTION SITE REACTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	3 / 20 (15.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	2 / 60 (3.33%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	1	3	0	0	0	0	0	0	0	0	0	2	0
MALAISE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	3 / 60 (5.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	1	0	1	2	1	0	0	0	0	1	0	0	0	0	1	3	2
MUCOSAL INFLAMMATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	2 / 10 (20.00%)	3 / 20 (15.00%)	3 / 20 (15.00%)	2 / 13 (15.38%)	4 / 20 (20.00%)	1 / 10 (10.00%)	2 / 8 (25.00%)	3 / 21 (14.29%)	6 / 20 (30.00%)	1 / 6 (16.67%)	4 / 21 (19.05%)	4 / 35 (11.43%)	1 / 19 (5.26%)	1 / 20 (5.00%)	2 / 27 (7.41%)	2 / 20 (10.00%)	1 / 20 (5.00%)	3 / 28 (10.71%)	2 / 20 (10.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	6 / 70 (8.57%)	17 / 60 (28.33%)	10 / 122 (8.20%)
occurrences all number	0	0	2	0	4	5	6	4	15	3	2	3	13	1	7	6	1	2	2	2	1	5	3	3	0	0	6	34	13
MULTIPLE ORGAN DYSFUNCTION SYNDROME
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
NON-CARDIAC CHEST PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	3	0	1	2	0	0	2	0	1
OEDEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 11 (18.18%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	3	0	2	1	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
OEDEMA PERIPHERAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	1 / 10 (10.00%)	3 / 20 (15.00%)	2 / 20 (10.00%)	3 / 13 (23.08%)	3 / 20 (15.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	1 / 21 (4.76%)	2 / 20 (10.00%)	3 / 6 (50.00%)	3 / 21 (14.29%)	4 / 35 (11.43%)	2 / 19 (10.53%)	0 / 20 (0.00%)	1 / 27 (3.70%)	3 / 20 (15.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	10 / 70 (14.29%)	3 / 60 (5.00%)	14 / 122 (11.48%)
occurrences all number	0	0	1	0	2	3	2	4	4	1	1	2	2	5	4	7	2	0	1	3	1	2	1	0	0	0	14	3	21
PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 13 (15.38%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	5 / 70 (7.14%)	2 / 60 (3.33%)	7 / 122 (5.74%)
occurrences all number	0	0	0	0	0	0	0	2	1	0	0	1	0	0	1	0	0	1	1	1	3	3	0	1	0	0	5	2	9
PERIPHERAL SWELLING
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	2 / 21 (9.52%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	1	3	0	1	0	2	0	0	0	0	0	0	0	0	0	0	1	1	3
PYREXIA
subjects affected / exposed	1 / 6 (16.67%)	1 / 3 (33.33%)	3 / 11 (27.27%)	1 / 4 (25.00%)	5 / 10 (50.00%)	2 / 20 (10.00%)	3 / 20 (15.00%)	1 / 13 (7.69%)	5 / 20 (25.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	4 / 21 (19.05%)	0 / 20 (0.00%)	2 / 6 (33.33%)	3 / 21 (14.29%)	2 / 35 (5.71%)	2 / 19 (10.53%)	4 / 20 (20.00%)	3 / 27 (11.11%)	1 / 20 (5.00%)	3 / 20 (15.00%)	3 / 28 (10.71%)	2 / 20 (10.00%)	1 / 20 (5.00%)	4 / 10 (40.00%)	0 / 10 (0.00%)	10 / 70 (14.29%)	6 / 60 (10.00%)	18 / 122 (14.75%)
occurrences all number	1	1	3	1	5	2	3	1	6	1	0	4	0	2	4	3	4	5	3	3	3	4	4	1	6	0	15	7	24
XEROSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Immune system disorders
CONTRAST MEDIA ALLERGY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
HYPERSENSITIVITY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	2 / 27 (7.41%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	3	1	0	0	1	0	0	0	0	1	0
SEASONAL ALLERGY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	1
Reproductive system and breast disorders
BREAST DISCHARGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
BREAST MASS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0
BREAST PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	3 / 20 (15.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	3 / 60 (5.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	3	0	0	1	0	0	0	0	3	0
DYSPAREUNIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
MENOPAUSAL SYMPTOMS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PELVIC PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	2
PENILE HAEMORRHAGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
UTERINE PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
VAGINAL DISCHARGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	2	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	2
VAGINAL HAEMORRHAGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	2	0	0
VULVAL DISORDER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
VULVOVAGINAL BURNING SENSATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
VULVOVAGINAL DRYNESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	5 / 60 (8.33%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	3	0	0	0	0	3	5	0
VULVOVAGINAL INFLAMMATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
VULVOVAGINAL PRURITUS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
COUGH
subjects affected / exposed	2 / 6 (33.33%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	3 / 10 (30.00%)	1 / 20 (5.00%)	2 / 20 (10.00%)	3 / 13 (23.08%)	3 / 20 (15.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	6 / 21 (28.57%)	5 / 20 (25.00%)	4 / 6 (66.67%)	4 / 21 (19.05%)	3 / 35 (8.57%)	2 / 19 (10.53%)	3 / 20 (15.00%)	3 / 27 (11.11%)	4 / 20 (20.00%)	4 / 20 (20.00%)	4 / 28 (14.29%)	5 / 20 (25.00%)	3 / 20 (15.00%)	1 / 10 (10.00%)	1 / 10 (10.00%)	13 / 70 (18.57%)	10 / 60 (16.67%)	20 / 122 (16.39%)
occurrences all number	2	0	0	1	5	1	2	5	5	1	1	6	5	5	4	3	2	4	3	4	5	4	5	7	1	1	15	12	23
DYSPHONIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	3 / 122 (2.46%)
occurrences all number	0	0	1	0	0	0	0	0	0	1	0	1	1	3	0	0	0	2	1	0	1	1	0	1	0	0	2	1	3
DYSPNOEA
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 11 (9.09%)	1 / 4 (25.00%)	3 / 10 (30.00%)	4 / 20 (20.00%)	4 / 20 (20.00%)	3 / 13 (23.08%)	4 / 20 (20.00%)	3 / 10 (30.00%)	1 / 8 (12.50%)	4 / 21 (19.05%)	3 / 20 (15.00%)	1 / 6 (16.67%)	5 / 21 (23.81%)	6 / 35 (17.14%)	0 / 19 (0.00%)	4 / 20 (20.00%)	2 / 27 (7.41%)	2 / 20 (10.00%)	5 / 20 (25.00%)	3 / 28 (10.71%)	4 / 20 (20.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	2 / 10 (20.00%)	10 / 70 (14.29%)	8 / 60 (13.33%)	12 / 122 (9.84%)
occurrences all number	1	0	1	1	3	11	5	5	6	4	1	4	5	1	9	7	0	4	5	2	7	5	4	4	0	2	11	10	15
DYSPNOEA EXERTIONAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	2 / 10 (20.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	1 / 13 (7.69%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	3	1	1	1	2	0	0	2	0	0	1	0	0	1	1	1	1	1	0	0	0	0	2	2	2
EPISTAXIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1	0	0	0	0	0	1	0	0	0	1	0	2
HAEMOPTYSIS
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
HICCUPS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	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	0	0	0
HYPOXIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	2	1	0	0	1	0	0	0	0	0	0	0	2	0	2
INCREASED UPPER AIRWAY SECRETION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
INTERSTITIAL LUNG DISEASE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
LARYNGEAL INFLAMMATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
LOWER RESPIRATORY TRACT CONGESTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
LUNG CONSOLIDATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
NASAL CONGESTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	3 / 20 (15.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	2 / 20 (10.00%)	5 / 28 (17.86%)	4 / 20 (20.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	6 / 70 (8.57%)	2 / 60 (3.33%)	2 / 122 (1.64%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	3	1	0	2	5	5	1	0	0	6	2	2
NASAL DRYNESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0
OROPHARYNGEAL DISCOMFORT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	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	0
OROPHARYNGEAL PAIN
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 19 (15.79%)	5 / 20 (25.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	4 / 28 (14.29%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	3 / 60 (5.00%)	4 / 122 (3.28%)
occurrences all number	1	0	0	1	0	0	1	0	1	0	0	0	1	1	1	1	3	6	1	0	0	5	2	0	0	0	1	3	4
PAINFUL RESPIRATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	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	0
PARANASAL SINUS DISCOMFORT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PARANASAL SINUS HYPERSECRETION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0
PLEURAL EFFUSION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	4 / 122 (3.28%)
occurrences all number	0	0	0	1	0	1	0	0	4	1	0	2	0	0	0	4	0	0	0	0	2	0	1	0	0	0	2	1	4
PLEURITIC PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	2	0	0	0	1	0	2
PNEUMONIA ASPIRATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PNEUMONITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	5 / 70 (7.14%)	1 / 60 (1.67%)	6 / 122 (4.92%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	2	0	4	2	1	0	0	2	0	2	1	0	2	1	0	5	2	7
PRODUCTIVE COUGH
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	3 / 70 (4.29%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	4	0	0	0	1	0	1	1	1	0	0	3	0	1
PULMONARY EMBOLISM
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0	0	0	0
PULMONARY OEDEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0
RHINITIS ALLERGIC
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	2 / 60 (3.33%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	1	0	0	0	1	2	1
RHINORRHOEA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	1	0	2	0	0	0	0	0	1	1	1	0	0	1	0	0	1	0	0	2	0
SINUS CONGESTION
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0	1	0	0	0	1	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0
SNEEZING
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
UPPER RESPIRATORY TRACT CONGESTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0
UPPER-AIRWAY COUGH SYNDROME
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	3 / 60 (5.00%)	0 / 122 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0	0	1	1	0	0	1	0	0	0	1	0	0	0	0	0	1	3	0
WHEEZING
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	2 / 27 (7.41%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	2 / 60 (3.33%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	2	0	0	1	0	0	0	0	0	2	3
Psychiatric disorders
ANXIETY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	3 / 20 (15.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	2 / 19 (10.53%)	2 / 20 (10.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	4 / 60 (6.67%)	8 / 122 (6.56%)
occurrences all number	0	0	1	0	1	0	2	0	3	2	0	2	1	0	0	1	2	2	0	1	0	0	1	0	0	0	2	4	8
DEPRESSION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	1 / 20 (5.00%)	3 / 27 (11.11%)	1 / 20 (5.00%)	2 / 20 (10.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	3 / 60 (5.00%)	4 / 122 (3.28%)
occurrences all number	0	0	0	0	1	0	0	0	3	0	0	1	0	0	1	1	0	1	7	1	2	1	1	1	0	0	1	5	4
AGITATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0	0
CONFUSIONAL STATE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0	0	0	0	1	1	0	0	0	0	0	1	0	0	0	0	1	0	2
INSOMNIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	2 / 20 (10.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	3 / 21 (14.29%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	1 / 19 (5.26%)	2 / 20 (10.00%)	3 / 27 (11.11%)	1 / 20 (5.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	3 / 70 (4.29%)	9 / 60 (15.00%)	9 / 122 (7.38%)
occurrences all number	0	0	1	0	1	1	2	1	1	0	0	3	1	0	1	1	1	2	3	1	1	2	1	1	0	1	3	10	9
LIBIDO DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0
MIXED ANXIETY AND DEPRESSIVE DISORDER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	4	0	0
MOOD ALTERED
subjects affected / exposed	2 / 6 (33.33%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0
MOOD SWINGS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0	0
Investigations
WEIGHT DECREASED
subjects affected / exposed	1 / 6 (16.67%)	2 / 3 (66.67%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	4 / 20 (20.00%)	3 / 20 (15.00%)	0 / 13 (0.00%)	4 / 20 (20.00%)	1 / 10 (10.00%)	2 / 8 (25.00%)	0 / 21 (0.00%)	3 / 20 (15.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	4 / 35 (11.43%)	1 / 19 (5.26%)	0 / 20 (0.00%)	2 / 27 (7.41%)	2 / 20 (10.00%)	4 / 20 (20.00%)	4 / 28 (14.29%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	14 / 70 (20.00%)	6 / 60 (10.00%)	24 / 122 (19.67%)
occurrences all number	1	3	1	0	0	4	3	0	7	2	2	0	4	0	3	4	1	0	3	2	4	4	5	0	0	0	23	6	36
ALANINE AMINOTRANSFERASE ABNORMAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	0 / 6 (0.00%)	1 / 3 (33.33%)	2 / 11 (18.18%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	3 / 20 (15.00%)	1 / 13 (7.69%)	2 / 20 (10.00%)	1 / 10 (10.00%)	2 / 8 (25.00%)	7 / 21 (33.33%)	3 / 20 (15.00%)	3 / 6 (50.00%)	4 / 21 (19.05%)	1 / 35 (2.86%)	2 / 19 (10.53%)	2 / 20 (10.00%)	2 / 27 (7.41%)	4 / 20 (20.00%)	0 / 20 (0.00%)	8 / 28 (28.57%)	3 / 20 (15.00%)	1 / 20 (5.00%)	3 / 10 (30.00%)	1 / 10 (10.00%)	2 / 70 (2.86%)	4 / 60 (6.67%)	6 / 122 (4.92%)
occurrences all number	0	1	2	0	2	1	6	1	2	2	2	13	5	6	5	1	11	5	3	9	0	12	5	1	5	1	2	7	11
AMYLASE INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	2 / 27 (7.41%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 10 (20.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	3 / 60 (5.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	0	0	0	0	1	0	0	0	4	0	0	1	0	1	3	2	0	3	2
ASPARTATE AMINOTRANSFERASE ABNORMAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	0	0	0	0	0	0
ASPARTATE AMINOTRANSFERASE INCREASED
subjects affected / exposed	0 / 6 (0.00%)	1 / 3 (33.33%)	1 / 11 (9.09%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	5 / 20 (25.00%)	2 / 13 (15.38%)	5 / 20 (25.00%)	2 / 10 (20.00%)	2 / 8 (25.00%)	8 / 21 (38.10%)	2 / 20 (10.00%)	3 / 6 (50.00%)	6 / 21 (28.57%)	1 / 35 (2.86%)	1 / 19 (5.26%)	4 / 20 (20.00%)	2 / 27 (7.41%)	3 / 20 (15.00%)	0 / 20 (0.00%)	6 / 28 (21.43%)	2 / 20 (10.00%)	3 / 20 (15.00%)	2 / 10 (20.00%)	2 / 10 (20.00%)	2 / 70 (2.86%)	5 / 60 (8.33%)	8 / 122 (6.56%)
occurrences all number	0	2	1	0	1	0	7	2	7	4	5	13	5	7	6	1	6	7	3	7	0	9	4	5	3	3	2	10	12
BAND NEUTROPHIL COUNT DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
BLOOD ALKALINE PHOSPHATASE INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	4 / 20 (20.00%)	0 / 10 (0.00%)	3 / 8 (37.50%)	5 / 21 (23.81%)	3 / 20 (15.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 35 (5.71%)	0 / 19 (0.00%)	2 / 20 (10.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	4 / 28 (14.29%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	11 / 122 (9.02%)
occurrences all number	0	0	1	0	0	3	1	0	5	0	5	6	4	0	1	2	0	2	1	1	0	4	0	1	0	0	2	2	19
BLOOD BILIRUBIN INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 10 (20.00%)	1 / 10 (10.00%)	4 / 70 (5.71%)	2 / 60 (3.33%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1	1	0	0	1	0	0	1	0	0	2	1	5	2	13
BLOOD CALCIUM DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	2
BLOOD CHLORIDE DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	1
BLOOD CHOLESTEROL INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	4 / 122 (3.28%)
occurrences all number	0	0	0	0	0	0	0	0	6	0	0	0	1	2	1	0	1	0	0	6	0	2	0	0	0	0	1	3	5
BLOOD CREATINE PHOSPHOKINASE INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	1 / 10 (10.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	7	1	0	0
BLOOD CREATININE INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	2 / 10 (20.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	2 / 13 (15.38%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	2 / 20 (10.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 35 (5.71%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	4 / 10 (40.00%)	1 / 10 (10.00%)	6 / 70 (8.57%)	2 / 60 (3.33%)	9 / 122 (7.38%)
occurrences all number	0	0	1	0	5	0	3	4	0	0	0	2	6	0	1	4	0	4	0	3	0	1	0	0	7	1	6	2	10
BLOOD INSULIN INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	0	0	0	0	0
BLOOD MAGNESIUM DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	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
BLOOD MAGNESIUM INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
BLOOD PHOSPHORUS INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0
BLOOD POTASSIUM DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	3	0	0	0	0	0	0	0	0
BLOOD TRIGLYCERIDES INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0
BLOOD UREA INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
ELECTROCARDIOGRAM QT PROLONGED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	1
GAMMA-GLUTAMYLTRANSFERASE INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	3 / 20 (15.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	2 / 60 (3.33%)	6 / 122 (4.92%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	3	0	1	1	0	1	0	1	0	0	0	0	0	0	1	3	7
HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
INTERNATIONAL NORMALISED RATIO INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	0	0	0	0	0	0
INVESTIGATION ABNORMAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
LIPASE INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	2 / 21 (9.52%)	0 / 35 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	2 / 27 (7.41%)	3 / 20 (15.00%)	0 / 20 (0.00%)	4 / 28 (14.29%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	6 / 122 (4.92%)
occurrences all number	0	0	0	0	0	1	3	0	0	1	0	0	3	1	3	0	4	1	4	4	0	6	0	0	1	1	0	1	7
LIVER FUNCTION TEST INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	1	4
LOW DENSITY LIPOPROTEIN INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	2	0	0	0	0	0	0	2	1	2
LYMPHOCYTE COUNT DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	4 / 20 (20.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	3 / 35 (8.57%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 27 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	3 / 20 (15.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	5	0	0	0	0	0	1	11	0	3	11	6	3	0	5	0	1	4	0	0	0	1	0	0
NEUTROPHIL COUNT DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	1 / 28 (3.57%)	4 / 20 (20.00%)	0 / 20 (0.00%)	4 / 10 (40.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	5	0	0	1	1	1	0	0	2	1	5	0	18	0	0	0	9
PLATELET COUNT DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	1 / 35 (2.86%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	3 / 122 (2.46%)
occurrences all number	0	0	1	0	0	3	0	0	0	1	0	2	1	0	2	1	0	1	0	0	1	2	0	0	0	0	3	1	4
STREPTOCOCCUS TEST POSITIVE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
TRANSAMINASES INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	0	0	0	0	4	0	0	1	0	0	1	0
TROPONIN INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
WEIGHT INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	2 / 60 (3.33%)	0 / 122 (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	2	0
WHITE BLOOD CELL COUNT DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	1	3	0	1	0	0	2	1	5
Injury, poisoning and procedural complications
FALL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	1 / 4 (25.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	3 / 20 (15.00%)	2 / 6 (33.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	2 / 27 (7.41%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	4 / 70 (5.71%)	2 / 60 (3.33%)	3 / 122 (2.46%)
occurrences all number	0	0	1	1	0	1	0	0	0	1	0	1	5	3	0	0	0	0	2	0	2	0	0	0	0	0	5	2	3
ANIMAL BITE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
BURN ORAL CAVITY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
CHEST INJURY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
CONTUSION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	3
ESCHAR
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
EYE INJURY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
HIP FRACTURE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
LIMB FRACTURE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0
LIMB INJURY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
POST PROCEDURAL HAEMORRHAGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PROCEDURAL PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	2 / 60 (3.33%)	1 / 122 (0.82%)
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	2	1
RADIATION SKIN INJURY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
RIB FRACTURE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
SKIN ABRASION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
SKIN LACERATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
SPINAL COMPRESSION FRACTURE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
SUNBURN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
ULNA FRACTURE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Cardiac disorders
ANGINA PECTORIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1	0	0	1
ARRHYTHMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0
ATRIAL FIBRILLATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	2 / 122 (1.64%)
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	2
ATRIOVENTRICULAR BLOCK FIRST DEGREE
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
BRADYCARDIA
subjects affected / exposed	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
BUNDLE BRANCH BLOCK LEFT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
LEFT VENTRICULAR FAILURE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
MITRAL VALVE INCOMPETENCE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PALPITATIONS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	1 / 70 (1.43%)	3 / 60 (5.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0	2	0	0	0	0	1	1	0	1	1	1	0	0	1	1	3	2
SINUS TACHYCARDIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	1	0	0
SUPRAVENTRICULAR TACHYCARDIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
TACHYCARDIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	2	0	0	0	0	0	0	0	1	0	0	1	0	3
Nervous system disorders
DIZZINESS
subjects affected / exposed	0 / 6 (0.00%)	2 / 3 (66.67%)	4 / 11 (36.36%)	1 / 4 (25.00%)	2 / 10 (20.00%)	3 / 20 (15.00%)	0 / 20 (0.00%)	4 / 13 (30.77%)	3 / 20 (15.00%)	3 / 10 (30.00%)	2 / 8 (25.00%)	6 / 21 (28.57%)	3 / 20 (15.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	3 / 35 (8.57%)	3 / 19 (15.79%)	3 / 20 (15.00%)	6 / 27 (22.22%)	3 / 20 (15.00%)	1 / 20 (5.00%)	5 / 28 (17.86%)	5 / 20 (25.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	9 / 70 (12.86%)	7 / 60 (11.67%)	11 / 122 (9.02%)
occurrences all number	0	2	5	2	2	3	0	4	5	4	2	9	3	0	2	3	5	4	7	3	1	6	6	3	0	0	11	9	18
HEADACHE
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	4 / 10 (40.00%)	2 / 20 (10.00%)	3 / 20 (15.00%)	1 / 13 (7.69%)	2 / 20 (10.00%)	2 / 10 (20.00%)	1 / 8 (12.50%)	5 / 21 (23.81%)	4 / 20 (20.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	6 / 19 (31.58%)	2 / 20 (10.00%)	4 / 27 (14.81%)	6 / 20 (30.00%)	5 / 20 (25.00%)	4 / 28 (14.29%)	8 / 20 (40.00%)	5 / 20 (25.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	6 / 70 (8.57%)	10 / 60 (16.67%)	10 / 122 (8.20%)
occurrences all number	1	0	1	0	6	3	4	1	3	2	3	14	7	1	0	0	6	3	6	9	5	4	10	7	0	0	10	11	10
BALANCE DISORDER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0
CARPAL TUNNEL SYNDROME
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
DISTURBANCE IN ATTENTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	3 / 122 (2.46%)
occurrences all number	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	3
DYSAESTHESIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	2
DYSARTHRIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
DYSGEUSIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	3 / 20 (15.00%)	1 / 20 (5.00%)	2 / 13 (15.38%)	3 / 20 (15.00%)	1 / 10 (10.00%)	3 / 8 (37.50%)	2 / 21 (9.52%)	2 / 20 (10.00%)	2 / 6 (33.33%)	1 / 21 (4.76%)	3 / 35 (8.57%)	1 / 19 (5.26%)	2 / 20 (10.00%)	3 / 27 (11.11%)	3 / 20 (15.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	2 / 20 (10.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	6 / 60 (10.00%)	9 / 122 (7.38%)
occurrences all number	0	0	0	0	1	4	1	3	3	1	7	2	2	3	1	3	1	2	3	3	0	2	2	2	0	0	5	6	9
HYPERSOMNIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
HYPOAESTHESIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	1	1	0	0	0	2	0	0	0	0	0	1	0	0	0	0	0	2	1	0	0	0	1	0	1
LETHARGY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	1	0	0	0	0	0	0	0
MEMORY IMPAIRMENT
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	2 / 27 (7.41%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	1	0	2	0	0	1	0	0	0	0	0	0	2
MIGRAINE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0
MUSCLE SPASTICITY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0
NEURALGIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1
NEUROPATHY PERIPHERAL
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	2 / 27 (7.41%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	5 / 60 (8.33%)	2 / 122 (1.64%)
occurrences all number	1	0	1	0	1	1	1	0	0	0	0	1	1	0	1	0	0	2	2	0	1	0	0	0	0	1	0	5	2
PARAESTHESIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	2 / 27 (7.41%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	1	0	0	1	0	1	0	1	0	0	0	0	1	0	2	0	1	0	0	2	0	0	1	1	3
PAROSMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
PERIPHERAL SENSORY NEUROPATHY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	2 / 10 (20.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	2	1	0	1	0	0	0	0	0	0	0	1	1	0	0	0	0	3	1	0	0	0	0	0	2
PRESYNCOPE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	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
SCIATICA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1	0	2
SEIZURE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
SINUS HEADACHE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
SOMNOLENCE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	1	1	3	0	2	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	1
SYNCOPE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1
TASTE DISORDER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	4	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	1	2
TREMOR
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	0	2
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 11 (9.09%)	1 / 4 (25.00%)	2 / 10 (20.00%)	4 / 20 (20.00%)	1 / 20 (5.00%)	2 / 13 (15.38%)	5 / 20 (25.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	6 / 21 (28.57%)	3 / 20 (15.00%)	0 / 6 (0.00%)	4 / 21 (19.05%)	5 / 35 (14.29%)	0 / 19 (0.00%)	2 / 20 (10.00%)	0 / 27 (0.00%)	4 / 20 (20.00%)	2 / 20 (10.00%)	2 / 28 (7.14%)	2 / 20 (10.00%)	0 / 20 (0.00%)	5 / 10 (50.00%)	0 / 10 (0.00%)	4 / 70 (5.71%)	3 / 60 (5.00%)	15 / 122 (12.30%)
occurrences all number	4	0	1	1	2	12	1	4	11	0	1	10	4	0	9	9	0	5	0	10	3	4	2	0	11	0	6	3	17
DISSEMINATED INTRAVASCULAR COAGULATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
FEBRILE NEUTROPENIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
IRON DEFICIENCY ANAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
LEUKOPENIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 11 (18.18%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	3	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
LYMPHOPENIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	10 / 122 (8.20%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	3	0	0	0	0	0	0	8	1	0	0	1	0	18
NEUTROPENIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	3 / 21 (14.29%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	2 / 20 (10.00%)	4 / 10 (40.00%)	3 / 10 (30.00%)	3 / 70 (4.29%)	1 / 60 (1.67%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	4	1	0	5	0	0	24	0	0	1	1	0	2	0	1	2	1	9	2	10	5	5	1	3
THROMBOCYTOPENIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	6 / 10 (60.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	8 / 122 (6.56%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1	1	0	0	1	0	0	0	0	0	0	0	0	0	30	0	0	1	14
Ear and labyrinth disorders
DEAFNESS UNILATERAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
EAR PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	1	0	1	2	0	0	1	0	0	1	0
EXCESSIVE CERUMEN PRODUCTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
HYPOACUSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
MOTION SICKNESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
TINNITUS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	1	0	0
VERTIGO
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	2	1	0
Eye disorders
DIPLOPIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1
DRY EYE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	4 / 60 (6.67%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	1	0	0	1	2	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	4	3
EXOPHTHALMOS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
EYE IRRITATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
EYE PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	1	2	0	0	0	0	1	0	0	0	0
EYE SWELLING
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0
EYELID DISORDER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
EYELID PTOSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
GLAUCOMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0
LACRIMATION INCREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	2 / 60 (3.33%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	1	0	0	1	1	1	0	0	0	0	1	2	1
OCULAR HYPERAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
ORBITAL OEDEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PERIORBITAL OEDEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0
PERIORBITAL SWELLING
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PHOTOPHOBIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1	0	0	0	0	1
PHOTOPSIA
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	5	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
SCLERAL HAEMORRHAGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
VISION BLURRED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	3 / 21 (14.29%)	2 / 20 (10.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	2 / 20 (10.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	2 / 60 (3.33%)	5 / 122 (4.10%)
occurrences all number	0	0	0	0	1	0	1	0	2	1	0	3	6	1	0	1	0	1	1	0	1	2	2	1	0	0	2	2	6
VISUAL IMPAIRMENT
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	1	0	1	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
VITREOUS FLOATERS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	2	0	0	0	0	0	0	0	0	0	1
Gastrointestinal disorders
DIARRHOEA
subjects affected / exposed	1 / 6 (16.67%)	2 / 3 (66.67%)	9 / 11 (81.82%)	1 / 4 (25.00%)	7 / 10 (70.00%)	16 / 20 (80.00%)	10 / 20 (50.00%)	9 / 13 (69.23%)	15 / 20 (75.00%)	5 / 10 (50.00%)	6 / 8 (75.00%)	14 / 21 (66.67%)	11 / 20 (55.00%)	4 / 6 (66.67%)	14 / 21 (66.67%)	16 / 35 (45.71%)	11 / 19 (57.89%)	11 / 20 (55.00%)	15 / 27 (55.56%)	14 / 20 (70.00%)	14 / 20 (70.00%)	20 / 28 (71.43%)	10 / 20 (50.00%)	8 / 20 (40.00%)	6 / 10 (60.00%)	5 / 10 (50.00%)	33 / 70 (47.14%)	42 / 60 (70.00%)	77 / 122 (63.11%)
occurrences all number	2	2	20	1	14	31	52	13	38	10	11	42	85	25	44	30	27	27	29	71	23	82	27	11	9	7	73	130	158
ABDOMINAL DISCOMFORT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	2 / 10 (20.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	3 / 21 (14.29%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	2 / 60 (3.33%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	2	0	0	0	1	1	0	5	2	0	0	0	0	0	0	0	1	2	0	1	0	0	0	2	2
ABDOMINAL DISTENSION
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	2 / 20 (10.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	5 / 28 (17.86%)	4 / 20 (20.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	7 / 70 (10.00%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	1	0	0	0	1	0	0	0	1	0	1	2	0	0	0	0	0	3	0	0	0	8	4	3	0	0	8	1	2
ABDOMINAL PAIN
subjects affected / exposed	1 / 6 (16.67%)	1 / 3 (33.33%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	2 / 20 (10.00%)	2 / 20 (10.00%)	3 / 13 (23.08%)	3 / 20 (15.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	4 / 21 (19.05%)	3 / 20 (15.00%)	2 / 6 (33.33%)	6 / 21 (28.57%)	6 / 35 (17.14%)	3 / 19 (15.79%)	1 / 20 (5.00%)	5 / 27 (18.52%)	2 / 20 (10.00%)	4 / 20 (20.00%)	5 / 28 (17.86%)	4 / 20 (20.00%)	5 / 20 (25.00%)	2 / 10 (20.00%)	0 / 10 (0.00%)	16 / 70 (22.86%)	11 / 60 (18.33%)	18 / 122 (14.75%)
occurrences all number	1	1	0	0	1	2	2	4	3	0	1	6	5	2	9	8	4	1	6	4	6	7	4	7	2	0	25	17	30
ABDOMINAL PAIN LOWER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	1	0	0	2	0	0	0	1	0	0	0	2	0	1
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	1 / 10 (10.00%)	3 / 20 (15.00%)	1 / 20 (5.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	4 / 21 (19.05%)	1 / 20 (5.00%)	2 / 6 (33.33%)	2 / 21 (9.52%)	2 / 35 (5.71%)	3 / 19 (15.79%)	1 / 20 (5.00%)	3 / 27 (11.11%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	2 / 20 (10.00%)	1 / 20 (5.00%)	2 / 10 (20.00%)	1 / 10 (10.00%)	4 / 70 (5.71%)	1 / 60 (1.67%)	6 / 122 (4.92%)
occurrences all number	0	0	1	0	1	5	1	1	1	0	0	7	1	4	2	2	3	1	3	0	0	1	2	1	2	1	4	1	6
ABDOMINAL WALL HAEMATOMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
ANAL HAEMORRHAGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
ANORECTAL DISCOMFORT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	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	1	0
APHTHOUS ULCER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0
ASCITES
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	2	1	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	2	1	1
CHAPPED LIPS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
CHEILITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	1	0	0	0	0	0	0
COLITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	2 / 20 (10.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	4 / 70 (5.71%)	9 / 60 (15.00%)	3 / 122 (2.46%)
occurrences all number	0	0	1	0	0	0	2	0	0	2	0	1	1	0	0	0	1	2	3	1	1	2	1	0	0	0	5	11	3
CONSTIPATION
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	2 / 10 (20.00%)	1 / 20 (5.00%)	4 / 20 (20.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	4 / 21 (19.05%)	2 / 20 (10.00%)	1 / 6 (16.67%)	3 / 21 (14.29%)	4 / 35 (11.43%)	6 / 19 (31.58%)	4 / 20 (20.00%)	5 / 27 (18.52%)	6 / 20 (30.00%)	4 / 20 (20.00%)	4 / 28 (14.29%)	4 / 20 (20.00%)	2 / 20 (10.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	10 / 70 (14.29%)	6 / 60 (10.00%)	15 / 122 (12.30%)
occurrences all number	1	0	1	0	2	1	5	1	1	0	0	4	3	1	6	4	7	4	7	7	5	5	4	2	1	0	13	7	16
DENTAL CARIES
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0
DIVERTICULUM INTESTINAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
DRY MOUTH
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	2 / 10 (20.00%)	2 / 20 (10.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	2 / 21 (9.52%)	1 / 20 (5.00%)	1 / 6 (16.67%)	2 / 21 (9.52%)	0 / 35 (0.00%)	2 / 19 (10.53%)	1 / 20 (5.00%)	3 / 27 (11.11%)	4 / 20 (20.00%)	2 / 20 (10.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	3 / 70 (4.29%)	6 / 60 (10.00%)	8 / 122 (6.56%)
occurrences all number	0	0	1	0	2	2	1	0	3	0	1	3	1	1	2	0	2	1	5	4	2	2	0	1	0	0	3	7	8
DYSPEPSIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	3 / 13 (23.08%)	0 / 20 (0.00%)	0 / 10 (0.00%)	2 / 8 (25.00%)	1 / 21 (4.76%)	5 / 20 (25.00%)	1 / 6 (16.67%)	2 / 21 (9.52%)	1 / 35 (2.86%)	2 / 19 (10.53%)	2 / 20 (10.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	2 / 20 (10.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	14 / 60 (23.33%)	7 / 122 (5.74%)
occurrences all number	0	0	0	0	1	0	3	3	0	0	2	1	7	1	2	1	2	3	0	1	2	2	1	2	0	0	3	16	7
DYSPHAGIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	3 / 20 (15.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	2 / 20 (10.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 19 (0.00%)	3 / 20 (15.00%)	0 / 27 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	2 / 60 (3.33%)	8 / 122 (6.56%)
occurrences all number	0	0	0	0	0	3	0	1	2	1	0	0	0	1	0	2	0	3	0	2	0	2	0	0	1	0	1	2	8
EPIGASTRIC DISCOMFORT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
ERUCTATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0	0	0	0	1	0
FAECES DISCOLOURED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
FLATULENCE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	2 / 19 (10.53%)	2 / 20 (10.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	3 / 28 (10.71%)	1 / 20 (5.00%)	2 / 20 (10.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	4 / 122 (3.28%)
occurrences all number	0	0	0	0	1	1	0	0	0	3	1	0	0	0	1	1	2	2	1	0	0	4	1	3	1	0	2	1	4
FREQUENT BOWEL MOVEMENTS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
GASTRIC ULCER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
GASTRITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	1 / 122 (0.82%)
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	0	0	0	1	1	1
GASTROOESOPHAGEAL REFLUX DISEASE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	3 / 20 (15.00%)	0 / 13 (0.00%)	5 / 20 (25.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	2 / 20 (10.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	1 / 20 (5.00%)	6 / 28 (21.43%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	4 / 70 (5.71%)	6 / 60 (10.00%)	7 / 122 (5.74%)
occurrences all number	0	0	1	0	0	1	4	0	5	1	0	2	0	1	1	1	0	2	1	1	1	6	0	1	0	1	4	6	7
GINGIVAL PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
GLOSSITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	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	1	1	0
GLOSSODYNIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
HAEMATOCHEZIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1
HAEMORRHOIDS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	3 / 28 (10.71%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	1	0	0	0	0	1	0	0	1	4	0	0	0	0	0	1	2
HYPERCHLORHYDRIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
HYPOAESTHESIA ORAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
LARGE INTESTINAL HAEMORRHAGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
LIP PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	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
MESENTERIC ARTERY THROMBOSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
MOUTH ULCERATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	2	0	1	0	0	0	0	0	0	1	0	0	0	2	0	0	0	0	2	0	0
NAUSEA
subjects affected / exposed	3 / 6 (50.00%)	1 / 3 (33.33%)	7 / 11 (63.64%)	1 / 4 (25.00%)	9 / 10 (90.00%)	7 / 20 (35.00%)	9 / 20 (45.00%)	6 / 13 (46.15%)	13 / 20 (65.00%)	6 / 10 (60.00%)	5 / 8 (62.50%)	13 / 21 (61.90%)	7 / 20 (35.00%)	6 / 6 (100.00%)	14 / 21 (66.67%)	11 / 35 (31.43%)	9 / 19 (47.37%)	9 / 20 (45.00%)	16 / 27 (59.26%)	6 / 20 (30.00%)	9 / 20 (45.00%)	17 / 28 (60.71%)	8 / 20 (40.00%)	7 / 20 (35.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	24 / 70 (34.29%)	27 / 60 (45.00%)	55 / 122 (45.08%)
occurrences all number	4	2	12	1	12	8	11	7	17	7	6	26	16	7	19	12	10	14	21	12	13	25	10	7	0	0	33	39	77
ODYNOPHAGIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	2 / 6 (33.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	3	0	0	0	1	0	0	0	1	0	0	1	0	0	0	2
OESOPHAGEAL PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
OESOPHAGITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	2
ORAL DYSAESTHESIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0	0
ORAL PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	5 / 122 (4.10%)
occurrences all number	0	0	1	0	0	1	1	0	0	0	0	1	2	1	1	1	0	0	0	0	0	1	0	0	0	0	0	1	6
PARAESTHESIA ORAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
PERIODONTAL DISEASE
subjects affected / exposed	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PROCTALGIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	4 / 122 (3.28%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	5	0	5
PROCTITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
RECTAL HAEMORRHAGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	1	0	0	1	0	1	0	0	0	0	0	0	0	2	1	0	0	0	0	0	0
RECTAL TENESMUS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
RETCHING
subjects affected / exposed	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
STOMATITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	3 / 11 (27.27%)	0 / 4 (0.00%)	4 / 10 (40.00%)	2 / 20 (10.00%)	3 / 20 (15.00%)	0 / 13 (0.00%)	9 / 20 (45.00%)	1 / 10 (10.00%)	2 / 8 (25.00%)	5 / 21 (23.81%)	4 / 20 (20.00%)	3 / 6 (50.00%)	4 / 21 (19.05%)	7 / 35 (20.00%)	3 / 19 (15.79%)	3 / 20 (15.00%)	6 / 27 (22.22%)	5 / 20 (25.00%)	3 / 20 (15.00%)	9 / 28 (32.14%)	4 / 20 (20.00%)	3 / 20 (15.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	6 / 70 (8.57%)	11 / 60 (18.33%)	26 / 122 (21.31%)
occurrences all number	0	0	4	0	5	3	5	0	11	1	6	7	5	4	4	9	4	3	12	7	4	16	8	3	1	0	6	21	40
TOOTHACHE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	4 / 70 (5.71%)	2 / 60 (3.33%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1	1	0	0	0	0	0	0	0	0	0	4	2	3
VARICOSE VEINS SUBLINGUAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
VOMITING
subjects affected / exposed	1 / 6 (16.67%)	2 / 3 (66.67%)	7 / 11 (63.64%)	0 / 4 (0.00%)	5 / 10 (50.00%)	4 / 20 (20.00%)	3 / 20 (15.00%)	5 / 13 (38.46%)	9 / 20 (45.00%)	2 / 10 (20.00%)	2 / 8 (25.00%)	8 / 21 (38.10%)	5 / 20 (25.00%)	4 / 6 (66.67%)	5 / 21 (23.81%)	4 / 35 (11.43%)	3 / 19 (15.79%)	2 / 20 (10.00%)	7 / 27 (25.93%)	2 / 20 (10.00%)	3 / 20 (15.00%)	5 / 28 (17.86%)	4 / 20 (20.00%)	4 / 20 (20.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	19 / 70 (27.14%)	6 / 60 (10.00%)	30 / 122 (24.59%)
occurrences all number	1	2	10	0	6	6	5	5	12	4	2	10	10	6	11	6	4	2	8	6	3	15	4	9	0	0	24	9	42
Hepatobiliary disorders
HEPATIC PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1	0	0	0	0	0	1
HYPERBILIRUBINAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
RASH
subjects affected / exposed	0 / 6 (0.00%)	1 / 3 (33.33%)	3 / 11 (27.27%)	0 / 4 (0.00%)	3 / 10 (30.00%)	5 / 20 (25.00%)	8 / 20 (40.00%)	2 / 13 (15.38%)	5 / 20 (25.00%)	3 / 10 (30.00%)	3 / 8 (37.50%)	6 / 21 (28.57%)	5 / 20 (25.00%)	4 / 6 (66.67%)	3 / 21 (14.29%)	4 / 35 (11.43%)	0 / 19 (0.00%)	1 / 20 (5.00%)	5 / 27 (18.52%)	4 / 20 (20.00%)	1 / 20 (5.00%)	4 / 28 (14.29%)	3 / 20 (15.00%)	1 / 20 (5.00%)	2 / 10 (20.00%)	1 / 10 (10.00%)	9 / 70 (12.86%)	15 / 60 (25.00%)	19 / 122 (15.57%)
occurrences all number	0	1	5	0	11	8	15	2	13	5	5	19	7	6	6	4	0	1	10	5	1	7	8	1	4	3	13	22	29
ALOPECIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	4 / 20 (20.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	5 / 27 (18.52%)	1 / 20 (5.00%)	2 / 20 (10.00%)	5 / 28 (17.86%)	2 / 20 (10.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	7 / 60 (11.67%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	1	0	2	0	4	2	0	1	2	1	0	0	1	1	6	1	2	6	2	1	0	0	1	8	3
BLISTER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
COLD SWEAT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
DECUBITUS ULCER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	2	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0
DERMATITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	1	0	0	0	0	0	0	0	0	0	0	1	0	0
DERMATITIS ACNEIFORM
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 35 (5.71%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 27 (3.70%)	2 / 20 (10.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	3	0	1	1	3	0	2	3	0	0	0	1	1	3
DERMATITIS ALLERGIC
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
DERMATITIS EXFOLIATIVE GENERALISED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
DRY SKIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	2 / 10 (20.00%)	3 / 20 (15.00%)	4 / 20 (20.00%)	0 / 13 (0.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	3 / 8 (37.50%)	3 / 21 (14.29%)	5 / 20 (25.00%)	2 / 6 (33.33%)	1 / 21 (4.76%)	2 / 35 (5.71%)	2 / 19 (10.53%)	2 / 20 (10.00%)	1 / 27 (3.70%)	2 / 20 (10.00%)	1 / 20 (5.00%)	5 / 28 (17.86%)	3 / 20 (15.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	7 / 70 (10.00%)	16 / 60 (26.67%)	9 / 122 (7.38%)
occurrences all number	0	0	0	0	4	3	4	0	3	0	3	7	5	4	3	2	2	2	1	2	1	6	3	1	0	0	7	18	11
DYSHIDROTIC ECZEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	0	0	0	0	0
ECCHYMOSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	2	0	0	0	3	1	1	0	0	0	0	0	1	0	0	0	0	0	0	0
ECZEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	1 / 10 (10.00%)	3 / 70 (4.29%)	1 / 60 (1.67%)	2 / 122 (1.64%)
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	3	1	5	1	5
ECZEMA ASTEATOTIC
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
ERYTHEMA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	2 / 10 (20.00%)	2 / 20 (10.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	1	6	2	2	0	1	1	1	2	0	0	0	1	0	0	0	2	0	1	1	0	0	1	0	1	2
EXFOLIATIVE RASH
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
HYPERHIDROSIS
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	1	1	1	2
INGROWING NAIL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
NAIL DISCOLOURATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
NAIL DISORDER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	2	0	0	0	0	1	1	2
NAIL DYSTROPHY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NIGHT SWEATS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	1	0	1	1	0	0	0	0	2
ONYCHOCLASIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	2 / 60 (3.33%)	0 / 122 (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	2	1	0	0	0	1	2	0
ONYCHOLYSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
ONYCHOMADESIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0	0	0	0
PAIN OF SKIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	1	0
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	1	0	0	0	0	1	0	0	0	0	0	0	0
PAPULE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
PHOTOSENSITIVITY REACTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	0 / 122 (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	3	0	0
PRURITUS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	3 / 10 (30.00%)	2 / 20 (10.00%)	2 / 20 (10.00%)	2 / 13 (15.38%)	1 / 20 (5.00%)	0 / 10 (0.00%)	4 / 8 (50.00%)	3 / 21 (14.29%)	1 / 20 (5.00%)	2 / 6 (33.33%)	4 / 21 (19.05%)	3 / 35 (8.57%)	3 / 19 (15.79%)	2 / 20 (10.00%)	3 / 27 (11.11%)	4 / 20 (20.00%)	1 / 20 (5.00%)	4 / 28 (14.29%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	6 / 70 (8.57%)	5 / 60 (8.33%)	16 / 122 (13.11%)
occurrences all number	0	0	0	0	4	3	2	2	1	0	7	7	1	2	5	3	4	2	4	5	2	7	0	1	0	0	10	10	23
PRURITUS ALLERGIC
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PSORIASIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
RASH ERYTHEMATOUS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1	0	1	0	0	0	0	4	2	0	0	0	0	0	1
RASH MACULAR
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	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	2
RASH MACULO-PAPULAR
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	2 / 21 (9.52%)	2 / 20 (10.00%)	1 / 6 (16.67%)	2 / 21 (9.52%)	3 / 35 (8.57%)	4 / 19 (21.05%)	3 / 20 (15.00%)	2 / 27 (7.41%)	2 / 20 (10.00%)	0 / 20 (0.00%)	4 / 28 (14.29%)	1 / 20 (5.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	5 / 70 (7.14%)	5 / 60 (8.33%)	18 / 122 (14.75%)
occurrences all number	0	0	1	0	1	3	2	0	0	1	1	3	2	4	2	3	4	10	5	2	0	10	1	4	0	1	7	9	26
RASH PAPULAR
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
RASH VESICULAR
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
ROSACEA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1	0	0	1
SEBORRHOEIC DERMATITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
SKIN EXFOLIATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	2
SKIN FISSURES
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	1	0	0	0	0	0	1	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1
SKIN HYPERPIGMENTATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
SKIN PLAQUE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
SKIN TIGHTNESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
SKIN ULCER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	1	0	0	0	0	0	1
URTICARIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Renal and urinary disorders
ACUTE KIDNEY INJURY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	2 / 10 (20.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	3 / 70 (4.29%)	1 / 60 (1.67%)	4 / 122 (3.28%)
occurrences all number	0	0	0	0	3	0	1	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	3	1	4
AZOTAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	6	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
BLADDER DISCOMFORT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
BLADDER SPASM
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1	0	0	0	0	0	0
CHROMATURIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
CYSTITIS NONINFECTIVE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
DYSURIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	2 / 13 (15.38%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	2 / 20 (10.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	1	1	2	0	0	0	3	2	0	1	1	0	1	0	0	0	2	0	0	0	0	2	0	1
HAEMATURIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 35 (8.57%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	3 / 70 (4.29%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	3	1	0	0	0	0	0	1	0	0	0	5	1	0
HYDRONEPHROSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	2 / 20 (10.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	2	0	1	0	0	0	0	2	1	0	0	0	0	2
MICTURITION URGENCY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	2	1	0	0	0	1	0	0	0	0	0	0	1	0
POLLAKIURIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	2 / 60 (3.33%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	1	2	0	0	2	0	0	1	0	1	0	1	0	0	0	1	2	3
POLYURIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
PROTEINURIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
RENAL FAILURE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
URETERIC OBSTRUCTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
URETERIC STENOSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
URINARY HESITATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
URINARY RETENTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	2	0	2
URINARY TRACT OBSTRUCTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	2 / 122 (1.64%)
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	1	0	2
URINARY TRACT PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	2 / 122 (1.64%)
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	1	0	2
Musculoskeletal and connective tissue disorders
BACK PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	4 / 20 (20.00%)	0 / 13 (0.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	5 / 21 (23.81%)	3 / 20 (15.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	5 / 35 (14.29%)	4 / 19 (21.05%)	4 / 20 (20.00%)	7 / 27 (25.93%)	4 / 20 (20.00%)	4 / 20 (20.00%)	4 / 28 (14.29%)	5 / 20 (25.00%)	3 / 20 (15.00%)	2 / 10 (20.00%)	1 / 10 (10.00%)	7 / 70 (10.00%)	8 / 60 (13.33%)	11 / 122 (9.02%)
occurrences all number	0	0	1	0	0	2	6	0	3	0	2	7	5	0	1	5	6	4	7	4	4	5	6	5	2	1	8	11	14
ARTHRALGIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	1 / 10 (10.00%)	3 / 20 (15.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	5 / 20 (25.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	3 / 21 (14.29%)	3 / 20 (15.00%)	2 / 6 (33.33%)	1 / 21 (4.76%)	4 / 35 (11.43%)	8 / 19 (42.11%)	2 / 20 (10.00%)	7 / 27 (25.93%)	5 / 20 (25.00%)	7 / 20 (35.00%)	10 / 28 (35.71%)	8 / 20 (40.00%)	5 / 20 (25.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	5 / 70 (7.14%)	14 / 60 (23.33%)	7 / 122 (5.74%)
occurrences all number	0	0	1	0	1	4	5	0	8	3	0	7	4	2	1	4	11	3	11	7	10	21	8	7	0	2	7	16	9
ARTHRITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2	1	0	0	1	0	0	0	0	1	2	0	0	0	0	1	0
BONE PAIN
subjects affected / exposed	1 / 6 (16.67%)	1 / 3 (33.33%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	2 / 19 (10.53%)	2 / 20 (10.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	3 / 20 (15.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	4 / 20 (20.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	4 / 60 (6.67%)	1 / 122 (0.82%)
occurrences all number	1	1	0	0	0	0	1	0	0	0	0	6	1	0	0	0	2	2	3	0	5	0	1	4	0	0	0	4	1
FLANK PAIN
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	1 / 20 (5.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	3 / 122 (2.46%)
occurrences all number	3	0	0	0	0	1	1	0	1	0	0	1	0	0	0	1	1	1	1	0	0	0	2	0	0	0	2	0	6
GROIN PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	1	0	0	1	0	0	0	0	0	0	0	1	0	2
INTERVERTEBRAL DISC PROTRUSION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
JOINT RANGE OF MOTION DECREASED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	1	0	0	0	0	0	1	0
JOINT SWELLING
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	4
MUSCLE DISORDER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
MUSCLE SPASMS
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	2 / 11 (18.18%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	3 / 20 (15.00%)	0 / 13 (0.00%)	3 / 20 (15.00%)	3 / 10 (30.00%)	3 / 8 (37.50%)	5 / 21 (23.81%)	1 / 20 (5.00%)	3 / 6 (50.00%)	3 / 21 (14.29%)	5 / 35 (14.29%)	1 / 19 (5.26%)	0 / 20 (0.00%)	5 / 27 (18.52%)	3 / 20 (15.00%)	2 / 20 (10.00%)	2 / 28 (7.14%)	5 / 20 (25.00%)	2 / 20 (10.00%)	1 / 10 (10.00%)	2 / 10 (20.00%)	5 / 70 (7.14%)	7 / 60 (11.67%)	9 / 122 (7.38%)
occurrences all number	2	0	2	0	1	1	3	0	4	4	6	10	1	5	4	6	1	0	7	3	2	3	5	2	1	2	8	8	11
MUSCLE TIGHTNESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1	0	1
MUSCULAR WEAKNESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	3 / 21 (14.29%)	1 / 20 (5.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	2 / 35 (5.71%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	0	2	1	1	0	4	1	0	2	2	1	0	0	0	1	1	0	0	0	0	2	0	3
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 27 (0.00%)	2 / 20 (10.00%)	3 / 20 (15.00%)	4 / 28 (14.29%)	1 / 20 (5.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	6 / 70 (8.57%)	2 / 60 (3.33%)	4 / 122 (3.28%)
occurrences all number	0	0	0	0	1	1	1	0	2	0	0	2	0	0	0	0	1	1	0	2	3	4	1	3	0	0	6	2	4
MUSCULOSKELETAL DISCOMFORT
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
MUSCULOSKELETAL PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	2 / 21 (9.52%)	0 / 20 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	1	2	0	1	0	0	1	0	1	0	0	3	3	0	0	0	1	0	1
MUSCULOSKELETAL STIFFNESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0
MYALGIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	3 / 20 (15.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	2 / 27 (7.41%)	3 / 20 (15.00%)	5 / 20 (25.00%)	5 / 28 (17.86%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	3 / 70 (4.29%)	2 / 60 (3.33%)	7 / 122 (5.74%)
occurrences all number	0	0	0	0	0	0	1	0	3	1	0	2	2	0	0	1	0	0	3	3	6	6	1	2	0	1	3	2	7
NECK PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	5 / 60 (8.33%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	1	0	3	0	0	0	0	0	0	1	1	1	0	0	1	2	1	1	1	0	1	5	2
OSTEONECROSIS OF JAW
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
PAIN IN EXTREMITY
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	3 / 11 (27.27%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	2 / 20 (10.00%)	2 / 13 (15.38%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	3 / 20 (15.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	1 / 19 (5.26%)	2 / 20 (10.00%)	5 / 27 (18.52%)	1 / 20 (5.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	6 / 70 (8.57%)	4 / 60 (6.67%)	2 / 122 (1.64%)
occurrences all number	0	0	3	0	0	1	2	2	2	1	0	3	4	1	1	2	1	2	5	1	1	1	1	5	0	0	6	5	2
PAIN IN JAW
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	0	0	0	1	0	0	1	0	1	0	0	1	0	0
SPINAL PAIN
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
Infections and infestations
BRONCHITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	1	1	2	0	0	0	0	0	0	0	0	2	0	1	1	0	0	0	0	0	1	0	0	0	0
NASOPHARYNGITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	1 / 21 (4.76%)	3 / 20 (15.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 27 (3.70%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	4 / 20 (20.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	3 / 60 (5.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	2	0	1	1	1	1	6	0	0	0	3	0	1	8	0	0	5	0	0	0	1	3	2
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	2 / 20 (10.00%)	1 / 13 (7.69%)	5 / 20 (25.00%)	2 / 10 (20.00%)	1 / 8 (12.50%)	3 / 21 (14.29%)	4 / 20 (20.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 19 (0.00%)	3 / 20 (15.00%)	0 / 27 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	4 / 28 (14.29%)	4 / 20 (20.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	3 / 70 (4.29%)	4 / 60 (6.67%)	6 / 122 (4.92%)
occurrences all number	2	0	1	0	0	2	2	1	7	2	1	3	6	2	0	2	0	3	0	2	0	5	6	1	2	0	3	4	13
URINARY TRACT INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	2 / 10 (20.00%)	1 / 20 (5.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	3 / 20 (15.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	3 / 21 (14.29%)	1 / 20 (5.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 35 (5.71%)	4 / 19 (21.05%)	2 / 20 (10.00%)	4 / 27 (14.81%)	3 / 20 (15.00%)	4 / 20 (20.00%)	1 / 28 (3.57%)	2 / 20 (10.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	12 / 70 (17.14%)	8 / 60 (13.33%)	16 / 122 (13.11%)
occurrences all number	0	0	0	1	2	1	2	0	3	0	1	6	1	0	1	2	5	2	6	4	4	1	2	1	1	0	17	8	18
BACTERAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
CANDIDA INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	1	1	0	1	0	0	0	0	0	1	0	0	0	0	1	2	0	0	0	0	0	1	3
CATHETER SITE INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
CELLULITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	1	3	0	3	0	0	0	0	0	0	1	1	0	0	0	0	0	0	2	0	0
CLOSTRIDIUM DIFFICILE INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	3 / 70 (4.29%)	2 / 60 (3.33%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	2	2
CONJUNCTIVITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 21 (4.76%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	1	1	2	0	0	0	1	0	0	0	0	1	1	0	1	1	0	0	3
CONJUNCTIVITIS VIRAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
CYSTITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	1 / 122 (0.82%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	1	1	1
CYTOMEGALOVIRUS INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
DEVICE RELATED INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	1	0	0
DIENTAMOEBA INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
EAR INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	1	0	0	0	0	0
ERYTHEMA INDURATUM
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
FUNGAL INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
FUNGAL SKIN INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	1 / 60 (1.67%)	0 / 122 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	1	1	0
FURUNCLE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	0 / 122 (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	1	0
GASTROINTESTINAL VIRAL INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	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
GINGIVITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
GROIN ABSCESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
HERPES ZOSTER
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	1	1	1	0	0	0	0	0	0
HORDEOLUM
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1
LARYNGITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
LOCALISED INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	1	0	2
LOWER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0	0	0
MASTITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	2	0	0	0	0	0
MUCOSAL INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
NAIL INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1
ORAL CANDIDIASIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	0	1	1	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	2
ORAL HERPES
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	1	0	2	0	0	1	0	1	0	0
PARONYCHIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	2
PHARYNGITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1	0	0	0	0	0	0	0	0	1	1	0	0	0
PNEUMONIA
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	2 / 11 (18.18%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	4 / 35 (11.43%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	3 / 70 (4.29%)	1 / 60 (1.67%)	2 / 122 (1.64%)
occurrences all number	1	0	2	0	0	1	0	1	1	2	0	0	0	0	1	6	0	0	1	0	0	0	0	1	1	0	3	1	2
PURULENT DISCHARGE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
PYELONEPHRITIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
RESPIRATORY SYNCYTIAL VIRUS INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 10 (20.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	1 / 60 (1.67%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	1	2	0	0	1	0	0	0	0	2	0	2	1	1
SINUSITIS
subjects affected / exposed	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	3 / 60 (5.00%)	1 / 122 (0.82%)
occurrences all number	1	0	0	0	0	1	0	1	0	0	0	0	2	0	0	0	0	0	0	3	0	1	1	2	0	0	0	3	1
SKIN CANDIDA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
SKIN INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	2	0	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0
STOMA SITE INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
TOOTH ABSCESS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
TOOTH INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	1	1
URINARY TRACT INFECTION BACTERIAL
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0
VAGINAL INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	1 / 60 (1.67%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1
VARICELLA ZOSTER VIRUS INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
VIRAL INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1
VIRAL UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0
VULVOVAGINAL MYCOTIC INFECTION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0	0
Metabolism and nutrition disorders
DECREASED APPETITE
subjects affected / exposed	1 / 6 (16.67%)	2 / 3 (66.67%)	7 / 11 (63.64%)	2 / 4 (50.00%)	6 / 10 (60.00%)	5 / 20 (25.00%)	8 / 20 (40.00%)	5 / 13 (38.46%)	7 / 20 (35.00%)	2 / 10 (20.00%)	3 / 8 (37.50%)	10 / 21 (47.62%)	8 / 20 (40.00%)	4 / 6 (66.67%)	6 / 21 (28.57%)	11 / 35 (31.43%)	4 / 19 (21.05%)	1 / 20 (5.00%)	8 / 27 (29.63%)	3 / 20 (15.00%)	8 / 20 (40.00%)	5 / 28 (17.86%)	7 / 20 (35.00%)	3 / 20 (15.00%)	2 / 10 (20.00%)	0 / 10 (0.00%)	23 / 70 (32.86%)	19 / 60 (31.67%)	38 / 122 (31.15%)
occurrences all number	1	2	9	3	7	6	13	6	12	3	3	17	13	5	7	12	6	1	11	7	14	6	8	4	3	0	41	30	53
DEHYDRATION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	4 / 11 (36.36%)	1 / 4 (25.00%)	2 / 10 (20.00%)	3 / 20 (15.00%)	1 / 20 (5.00%)	3 / 13 (23.08%)	6 / 20 (30.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	4 / 21 (19.05%)	1 / 20 (5.00%)	3 / 6 (50.00%)	1 / 21 (4.76%)	4 / 35 (11.43%)	1 / 19 (5.26%)	0 / 20 (0.00%)	2 / 27 (7.41%)	1 / 20 (5.00%)	1 / 20 (5.00%)	3 / 28 (10.71%)	3 / 20 (15.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	7 / 70 (10.00%)	0 / 60 (0.00%)	14 / 122 (11.48%)
occurrences all number	0	0	6	1	3	3	2	5	18	0	3	4	1	4	1	5	1	0	3	1	1	3	3	1	1	0	9	0	23
ELECTROLYTE IMBALANCE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
FAILURE TO THRIVE
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	1	0	0	0	0	0	0	0
FLUID OVERLOAD
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
GLUCOSE TOLERANCE IMPAIRED
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1
HYPERCALCAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	2	0	0	1	0	1	0	0	0
HYPERCHOLESTEROLAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	4 / 60 (6.67%)	2 / 122 (1.64%)
occurrences all number	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	1	5	3
HYPERGLYCAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	8 / 11 (72.73%)	2 / 4 (50.00%)	3 / 10 (30.00%)	12 / 20 (60.00%)	5 / 20 (25.00%)	3 / 13 (23.08%)	9 / 20 (45.00%)	5 / 10 (50.00%)	4 / 8 (50.00%)	8 / 21 (38.10%)	6 / 20 (30.00%)	3 / 6 (50.00%)	8 / 21 (38.10%)	6 / 35 (17.14%)	1 / 19 (5.26%)	2 / 20 (10.00%)	7 / 27 (25.93%)	6 / 20 (30.00%)	4 / 20 (20.00%)	11 / 28 (39.29%)	5 / 20 (25.00%)	4 / 20 (20.00%)	7 / 10 (70.00%)	3 / 10 (30.00%)	14 / 70 (20.00%)	13 / 60 (21.67%)	43 / 122 (35.25%)
occurrences all number	0	0	22	2	9	32	10	9	21	17	9	21	14	21	16	7	1	4	17	10	5	29	12	5	31	3	17	24	96
HYPERKALAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	2 / 122 (1.64%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2
HYPERMAGNESAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0	0	0	0	0
HYPERPHOSPHATAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
HYPERTRIGLYCERIDAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	2 / 20 (10.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	1	0	0	1	1	0	3	0	0	0	0	0	1	0	0	0	1	6	0	1	0	0	0	1	0	0	1
HYPERURICAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
HYPOALBUMINAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	1 / 4 (25.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	2 / 70 (2.86%)	0 / 60 (0.00%)	4 / 122 (3.28%)
occurrences all number	0	0	0	1	0	3	0	0	0	0	0	1	0	0	3	1	0	1	1	0	0	2	0	0	0	0	5	0	7
HYPOCALCAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	2 / 60 (3.33%)	3 / 122 (2.46%)
occurrences all number	0	0	0	0	0	0	1	3	1	0	0	1	2	0	0	0	0	1	0	0	0	3	0	0	0	0	0	3	3
HYPOGLYCAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0
HYPOKALAEMIA
subjects affected / exposed	1 / 6 (16.67%)	1 / 3 (33.33%)	4 / 11 (36.36%)	0 / 4 (0.00%)	2 / 10 (20.00%)	5 / 20 (25.00%)	5 / 20 (25.00%)	2 / 13 (15.38%)	7 / 20 (35.00%)	2 / 10 (20.00%)	3 / 8 (37.50%)	5 / 21 (23.81%)	3 / 20 (15.00%)	4 / 6 (66.67%)	5 / 21 (23.81%)	2 / 35 (5.71%)	0 / 19 (0.00%)	1 / 20 (5.00%)	3 / 27 (11.11%)	6 / 20 (30.00%)	1 / 20 (5.00%)	2 / 28 (7.14%)	1 / 20 (5.00%)	1 / 20 (5.00%)	2 / 10 (20.00%)	0 / 10 (0.00%)	8 / 70 (11.43%)	6 / 60 (10.00%)	23 / 122 (18.85%)
occurrences all number	1	1	4	0	5	8	7	4	7	4	4	6	4	13	8	3	0	1	5	12	1	3	1	1	2	0	9	6	40
HYPOMAGNESAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 11 (9.09%)	0 / 4 (0.00%)	0 / 10 (0.00%)	5 / 20 (25.00%)	2 / 20 (10.00%)	0 / 13 (0.00%)	3 / 20 (15.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	2 / 21 (9.52%)	3 / 20 (15.00%)	1 / 6 (16.67%)	4 / 21 (19.05%)	3 / 35 (8.57%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 27 (3.70%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	7 / 70 (10.00%)	2 / 60 (3.33%)	12 / 122 (9.84%)
occurrences all number	0	0	1	0	0	8	2	0	4	4	0	2	5	3	5	3	0	0	2	1	0	0	1	2	0	0	8	2	21
HYPONATRAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	3 / 11 (27.27%)	0 / 4 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	4 / 21 (19.05%)	0 / 20 (0.00%)	0 / 6 (0.00%)	4 / 21 (19.05%)	2 / 35 (5.71%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	4 / 70 (5.71%)	1 / 60 (1.67%)	12 / 122 (9.84%)
occurrences all number	0	0	3	0	1	1	0	0	1	1	0	9	0	0	7	2	1	0	0	0	0	1	0	1	0	0	4	1	22
HYPOPHAGIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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
HYPOPHOSPHATAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	1 / 10 (10.00%)	3 / 20 (15.00%)	0 / 20 (0.00%)	1 / 13 (7.69%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 6 (0.00%)	3 / 21 (14.29%)	6 / 35 (17.14%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 27 (3.70%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 28 (7.14%)	3 / 20 (15.00%)	1 / 20 (5.00%)	1 / 10 (10.00%)	0 / 10 (0.00%)	8 / 70 (11.43%)	1 / 60 (1.67%)	7 / 122 (5.74%)
occurrences all number	0	0	0	0	1	3	0	3	1	0	0	2	1	0	3	7	1	0	1	0	0	3	3	1	1	0	12	1	16
HYPOVOLAEMIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	1 / 122 (0.82%)
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	1
LACTIC ACIDOSIS
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	1 / 10 (10.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (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	1	0	0	0
MALNUTRITION
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	2 / 20 (10.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 28 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	1 / 70 (1.43%)	0 / 60 (0.00%)	1 / 122 (0.82%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1
POLYDIPSIA
subjects affected / exposed	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 11 (0.00%)	0 / 4 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 13 (0.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 27 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 28 (3.57%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 10 (0.00%)	0 / 10 (0.00%)	0 / 70 (0.00%)	0 / 60 (0.00%)	0 / 122 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

15 Aug 2011

Changes in Protocol v2 were as follows: DLT definition for Grade ≥3 hyperglycemia was revised to include use of anti-hyperglycemic medication for adequate time period to manage hyperglycemia. Guidelines for hyperglycemia management were updated. Inclusion criterion regarding subjects with prostate cancer was revised to include a requirement that subjects must be castrate-resistant. Inclusion criterion for subjects with ovarian cancer based on CA-125 levels was revised to be consistent with Gynecologic Cancer Intergroup (GCIG) Criteria for Evaluation According to CA-125. Appendix E was revised to reflect these criteria. Requirement for subjects to receive standard low-fat meal at 4 hr postdose was removed. Use of proton-pump inhibitors, H2-histamine receptor antagonists, antacids were excluded only for subjects in Stage 2. Language regarding use of hematopoietic colony-stimulating factors was revised to add that these agents should not be initiated or increased in dose from 7 days before Cycle 1 Day 1 until completion of the DLT Assessment Window in the absence of DLT. Clarification was made so pretreatment FDG-PET scans should be performed within 14 days prior to dosing on Day 1 of Cycle 1 with GDC-0032. Change was made so that FDG-PET scans were made mandatory beginning with Cohort 2 in Stage 1. Paired tumor biopsies were required from at least six subjects in Stage 2, instead of all subjects in Stage 2. Details of statistical analyses of PI3K-pathway inhibition were added. Details on sample size determination, including probabilities of dose escalation with different underlying rates of DLT were added. Procedures for recording persistent or recurrent adverse events were clarified to provide additional guidance for recording changes in severity. Appendix G was revised to include modifications to EORTC definitions for PET responses and to revise guidelines for FDG-PET imaging acquisition.

18 Apr 2012

Changes in Protocol v3 were as follows: The title was modified as follows: An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients with Locally Advanced or Metastatic Solid Tumors and in Combination with Endocrine Therapy in Patients with Locally Advanced or Metastatic Hormone Receptor- Positive Breast Cancer. The sample size was changed from approximately 36−60 to 104−122. The number of study centers was changed from 3−6 to approximately 3−9 study centers in the United States and in Europe. References to the schedule of assessments were modified to include Appendices A-1 to A-6 and B-1 to B-6, where applicable. CYP3A4/5 was replaced with CYP3A4 only. Phosphorus was added to the panel of serum chemistry assessments. Glycosylated hemoglobin (HbA1C) was added to the local laboratory assessments.

07 Mar 2013

Changes in Protocol v5 were as follows: A Phase II portion was added. This consisted of an open-label, single-arm study that will enroll a total of 60 subjects with HER2-negative, hormone receptor-positive breast cancer to be treated with GDC-0032 and fulvestrant. Dose of GDC-0032 in combination with fulvestrant was based upon clinical data obtained in Stage 1 and Stage 2. Statistical justification for the sizing of this study was included. Cohorts A and B in Stage 2 were increased in size to 20 subjects. Rationale and statistical justification for this change was added. Cohort G in Stage 2 was added and consisted of 20 subjects with solid tumors that had increased PIK3CA copy number. Rationale and statistical justification for this cohort was added. The subject numbers for Stage 2, Cohorts E and F were clarified. Approximately 20−26 subjects were enrolled in Cohorts E and F since subjects had been treated at 2 dose levels. Six subjects were tested at 9 mg dose level prior to the decision to expand to a total of 20 subjects at 6 mg. Language clarifying this was added. Dose modification guidelines were updated to provide clearer guidance to investigators. Several adverse events of special interest were added. Clinical data were updated and includes safety and efficacy data. Updates to the dose selected for Stage 2 cohorts were included.Inclusion criteria regarding hemoglobin and liver function tests in the setting of liver metastases were updated to reflect the subjects population that would be appropriate candidates for this trial. Exclusion criteria regarding subjects with brain metastases and language regarding GDC-0032 treatment after treatment of brain metastases were updated to better reflect the subject population eligible for this study and the risk-benefit profile for treatment with GDC-0032.

24 Jun 2013

Changes in Protocol v6 were as follows: Clinical safety data were updated. Toxicities observed with GDC-0032 in clinical studies were updated. This included updated data on colitis observed in GDC-0032 trials. Management guidelines for toxicities including hyperglycemia, pneumonitis, rash, diarrhea, colitis, stomatitis, and other clinically significant adverse events were updated. Eligibility criteria were updated to exclude subjects with active small or large intestine inflammation such as Crohn’s disease or ulcerative colitis. Protocol-defined events of special interest were updated to include Grade ≥ 2 colitis or enterocolitis and Grade ≥ 3 diarrhea.

16 Dec 2013

Changes in Protocol v7 were as follows: Additional cohorts (Cohorts J, K and L) were added to investigate different dosing schedules of GDC-0032 in combination with fulvestrant. Preliminary efficacy in Cohort F had demonstrated that some subjects who started at GDC-0032 6-mg QD dose and then dose reduced to 3 mg QD still maintained a partial response. Several alternate dose schedules were tested to obtain further data on relative tolerability of adding intermittent breaks to GDC-0032 dosing schedule. Preliminary efficacy was observed in expansion cohort of solid non-breast tumors with PIK3CA mutation (Cohort B). Cohort H was added and will test GDC-0032 QD on a 21-day on, 7-day off schedule in approximately 40 subjects with non-breast, non-colorectal solid tumors. Management guidelines for diarrhea were updated to reflect the increased clinical experience of GDC-0032. For non-infectious diarrhea, corticosteroid treatment was useful in alleviating symptoms. Dose modification guidelines for diarrhea and colitis were updated as prompt management of Grade 2 diarrhea may prevent worsened subsequent gastrointestinal toxicities. Language was added to provide investigators the option to treat subjects with asymptomatic increases in lipase and amylase lab values. Inclusion criteria regarding Phase II population was clarified. Phase II subjects must be postmenopausal, HER2-negative, and hormone receptor-positive breast cancer subjects. Exclusion criteria was modified to reflect clinical practice regarding the minimal washout time for oral endocrine agents taken daily. Washout was decreased from 3 weeks to 2 weeks (e.g., letrozole, anastrozole, exemestane, tamoxifen). Exclusion criteria regarding hypokalemia and hypomagnesemia was removed to reflect clinical practice while maintaining subject safety based upon updated GDC-0032 clinical data. Enrollment numbers for Stage 2, Cohorts C−F have been updated to reflect actual enrollment into study. Clinical safety data was updated.

12 May 2014

Changes in Protocol v8 were as follows: GDC-0032 tablet formulation information was added to allow the use of tablets in this study. Information regarding the relative bioavailability of GDC-0032 capsules and tablets was included. The dose modification table (Table 8) was updated to reflect usage of tablets. Cohorts M, N and P were added to investigate daily dosing of 2 mg GDC-0032 tablets in combination with fulvestrant or letrozole and 4 mg GDC-0032 in tablet form dosed daily with letrozole. The requirement for taking GDC-0032 on an empty stomach was removed. To allow subjects currently being treated with GDC-0032 via capsules to continue obtaining GDC-0032 treatment, subjects may be switched over from capsules to tablets. Management guidelines for adverse events of special interest were updated. More detailed information on the dosage of recommended corticosteroids for diarrhea and colitis was included. In addition, extra language regarding caution with using steroids was added.

31 Mar 2015

Changes in Protocol v9 were as follows: The title of the study was revised to add subjects with non-Hodgkin’s lymphoma. The formulation of the study drug, GDC-0032 (capsule or tablet), was added to each reference of the drug for clarity.

29 Sep 2016

Changes in Protocol v10 were as follows: Cohorts Q, R, and S, which will enroll postmenopausal subjects with locally advanced or metastatic HER2-negative, hormone receptor−positive breast cancer that had progressed or failed to respond to at least one prior endocrine therapy in the adjuvant or metastatic setting, were added to evaluate alternative dosing schedules of GDC 0032 in combination with letrozole. Cohort T enrolled subjects with non-Hodgkin’s lymphoma whose cancers have progressed or failed to respond to at least one prior regimen and who are not candidates for regimens known to provide clinical benefit. Cohort X enrolled subjects with PIK3CA-mutant solid tumors whose cancers had progressed or failed to respond to at least one prior regimen and who are not candidates for regimens known to provide clinical benefit. The PK measurements for Cohorts L and S were modified. In sub-Cohort X3, more-dense PK measurements were made for subjects with head and neck cancer taking GDC-0032 in suspension form. Cohort T had additional specific assessments based on the International Working Group Revised Response Criteria for Malignant Lymphoma, including assessment of B-symptoms and bone marrow aspiration and biopsy. Six additional subject slots (3 subjects with PIK3CA wild-type and 3 subjects with PIK3CA-mutant tumors) were added to each of the letrozole combination Cohorts N and P. Specific alkaline phosphatase levels were removed as inclusion criteria. Additional inclusion and exclusion criteria were added to allow for subjects with additional cancers such as head and neck squamous-cell carcinomas (HNSCC) and non-Hodgkin’s lymphomas. Management guidelines for GDC-0032-related toxicities were updated. Tables, figures, and appendices were modified to reflect changes to the protocol.

12 Jul 2018

Changes in Protocol v11 were as follows: The following sections were updated to reflect these changes: Section 3.1 (Description of the Study), Section 4.5 (Study Assessments), Section 4.5.3 (Assessments during Treatment), Appendix A-7 (Study Flowchart: Stage 2, Cohorts H, J, K, L, M, N, P, Q, R, S, T, T2, and X [X1-X11] before LPI - 6 Months). The new adverse drug reactions were added to Section 3.4.3, and management guidelines for infection were added to Section 3.4.5.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
31 May 2021	The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability.	-

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

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Phase I Stage 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0)

Primary: Phase I Stage 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0)

Primary: Phase I Stage 2 Cohorts E and F: Percentage of Participants with DLTs as Assessed by NCI CTCAE v4.0

Primary: Phase I Stage 2 Cohorts E and F: Percentage of Participants with DLTs as Assessed by NCI CTCAE v4.0

Primary: Phase I: AUC From Zero to tau (AUCtau) of GDC-0032

Primary: Phase I: AUC From Zero to tau (AUCtau) of GDC-0032

Primary: Phase I: Maximum Observed Plasma Concentration (Cmax) of GDC-0032

Primary: Phase I: Maximum Observed Plasma Concentration (Cmax) of GDC-0032

Primary: Phase I: Time to Reach Cmax (tmax) of GDC-0032

Primary: Phase I: Time to Reach Cmax (tmax) of GDC-0032

Primary: Phase I: Terminal Half-life (t1/2) of GDC-0032

Primary: Phase I: Terminal Half-life (t1/2) of GDC-0032

Primary: Across All Cohorts (Except Cohorts T and T2): Percentage of Participants With Best Overall Response (BOR) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Primary: Across All Cohorts (Except Cohorts T and T2): Percentage of Participants With Best Overall Response (BOR) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Primary: Across All Cohorts (Except Cohorts T and T2): Duration of Objective Response (DOR) as Assessed Using RECIST v1.1

Primary: Across All Cohorts (Except Cohorts T and T2): Duration of Objective Response (DOR) as Assessed Using RECIST v1.1

Primary: Across All Cohorts (Except Cohorts T and T2): Progression-Free Survival (PFS) as Assessed Using RECIST v1.1

Primary: Across All Cohorts (Except Cohorts T and T2): Progression-Free Survival (PFS) as Assessed Using RECIST v1.1

Primary: Percentage of Participants With BOR in Cohort T and T2

Primary: Percentage of Participants With BOR in Cohort T and T2

Primary: DOR in Cohort T and T2

Primary: DOR in Cohort T and T2

Primary: PFS in Cohort T and T2

Primary: PFS in Cohort T and T2

Secondary: Phase I Stage 1: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by NCI CTCAE v4.0 grade

Secondary: Phase I Stage 1: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by NCI CTCAE v4.0 grade

Secondary: Phase I Stage 2: Percentage of Participants with AEs and SAEs by NCI CTCAE v4.0 grade

Secondary: Phase I Stage 2: Percentage of Participants with AEs and SAEs by NCI CTCAE v4.0 grade

Secondary: Phase II: Percentage of Participants with AEs and SAEs by NCI CTCAE v4.0 grade

Secondary: Phase II: Percentage of Participants with AEs and SAEs by NCI CTCAE v4.0 grade

Secondary: Percentage of Participants with Clinical Relevant Shifts from Baseline in Laboratory Parameters

Secondary: Percentage of Participants with Clinical Relevant Shifts from Baseline in Laboratory Parameters

Secondary: Cmax of GDC-0032 Under Fed Conditions

Secondary: Cmax of GDC-0032 Under Fed Conditions

Secondary: AUC of GDC-0032 Under Fed Conditions

Secondary: AUC of GDC-0032 Under Fed Conditions

Secondary: Cmax of GDC-0032 Under Fasted Conditions

Secondary: Cmax of GDC-0032 Under Fasted Conditions

Secondary: AUC of GDC-0032 Under Fasted Conditions

Secondary: AUC of GDC-0032 Under Fasted Conditions

Secondary: Geometric Mean Ratio of Cmax for Midazolam plus GDC-0032 Relative to Cmax for Midazolam Alone

Secondary: Geometric Mean Ratio of Cmax for Midazolam plus GDC-0032 Relative to Cmax for Midazolam Alone

Secondary: Geometric Mean Ratio of AUC for Midazolam plus GDC-0032 Relative to AUC for Midazolam Alone

Secondary: Geometric Mean Ratio of AUC for Midazolam plus GDC-0032 Relative to AUC for Midazolam Alone

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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