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Clinical Trial Results:
TAX-TORC: A Phase I multi-centre trial of the combination of AZD2014 (dual TORC1 and TORC2 inhibitor) and weekly paclitaxel in patients with solid tumours

Summary
EudraCT number	2012-003896-20
Trial protocol	GB
Global end of trial date	04 Feb 2019

Results information
Results version number	v1(current)
This version publication date	23 Sep 2020
First version publication date	23 Sep 2020
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

CCR3667

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

The Institute of Cancer Research

Sponsor organisation address

15 Cotwold Road, Sutton, United Kingdom,

Public contact

Alison Turner, Royal Marsden Hospital Drug Development Unit, +44 2086613752, alison.turner@icr.ac.uk

Scientific contact

Alison Turner, Royal Marsden Hospital Drug Development Unit, +44 2086613752, alison.turner@icr.ac.uk

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

04 Feb 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

04 Feb 2019

Global end of trial reached?

Yes

Global end of trial date

04 Feb 2019

Was the trial ended prematurely?

Main objective of the trial

To establish the MTD and recommended dose of two intermittent dosing schedules of AZD2014: 3 days on/4days off and 2 days on 5 days off in combination with weekly paclitaxel in patients with solid tumours. To assess the safety and toxicity profile of the combination of AZD2014 and weekly paclitaxel.

Protection of trial subjects

As this is a phase I trial, there are stopping rules for toxicity during this study (parts A and B): Regular weekly to 2-weekly safety reviews will be conducted between the Principal Investigator or delegate from each investigational site and DDU Clinical Trials Manager or delegate. Decisions will be based on all relevant data available from all dose levels evaluated in the ongoing study including safety information, DLTs, all CTCAE Grade ≥ 2 toxicity data, available PK, and PD data from evaluable patients. If at any time, 2 or more DLTs have occurred in a specific dose level, one of the following actions will be implemented: • Proceed with dose escalation • Expand the cohort to a maximum of 6 evaluable patients • De-escalate the dose • Define the MTD (where 6 evaluable patients are assessed) • Stop the study Formal review of toxicity and intrapatient dose escalation data will be undertaken by the SRC when 3 patients have completed approximately 9 weeks of treatment on either schedule, and at the end of the dose escalation phase, for selection of the dose expansion schedule. During dose expansion, SRC meetings will be held regularly for safety review (e.g. every 5-10 patients). Additional SRC meetings will be organised in the event of safety concerns, e.g. with the intrapatient dose escalation strategy, for consideration of reverting to a classic 3+3 phase I dose escalation scheme. The SRC will consist of: • Chief Investigator or delegate • Principal Investigator or delegate from each investigational site • DDU Pharmacovigilance Officer or delegate • DDU Clinical Trials Manager or delegate • Senior ECMC clinician (who is not CI) Representatives of AstraZeneca and Cancer Research UK’s Drug Development Office will also be invited to attend the SRC meetings as non-voting participants. Further internal or external experts may be consulted by the SRC as necessary.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Mar 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 97

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Adult patients with solid tumours will be enrolled into the dose escalation phase of the study. Patients with ovarian cancer and patients with squamous lung cancer will be enrolled in the expansion phase.

Screening details

The patient must fulfil the eligibility criteria.

Period 1 title

Treatment (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Escalation: 3 days on, 4 days off (Schedule A)

Arm description

Arm type

Dosing Schedule

Investigational medicinal product name

AZD2014

Investigational medicinal product code

Other name

Pharmaceutical forms

Coated tablet

Routes of administration

Oral use

Dosage and administration details

BD intermittent 3 days on 4 days off schedule (Schedule A): AZD2014 (25 mg, 50 mg and 75 mg)

Investigational medicinal product name

Paclitaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate and solvent for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

BD intermittent 3 days on 4 days off schedule (Schedule A): paclitaxel (80mg/m2) intravenously every week (D1, D8, D15, D22, D29, D36) for 6 weeks followed by a 1 week break (1 cycle).

Escalation: 2 days on, 5 days off (Schedule B)

Arm description

Arm type

Dosing schedule

Investigational medicinal product name

AZD2014

Investigational medicinal product code

Other name

Pharmaceutical forms

Coated tablet

Routes of administration

Oral use

Dosage and administration details

BD intermittent 2 days on 5 days off schedule (Schedule B): AZD2014 (25 mg, 50 mg, 75 mg and 100mg)

Investigational medicinal product name

Paclitaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate and solvent for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

BD intermittent 2 days on 5 days off schedule (Schedule B): paclitaxel (80mg/m2) intravenously every week (D1, D8, D15, D22, D29, D36) for 6 weeks followed by a 1 week break (1 cycle).

Expansion: 3 days on, 4 days off (Schedule A)

Arm description

Arm type

Experimental

Investigational medicinal product name

AZD2014

Investigational medicinal product code

Other name

Pharmaceutical forms

Coated tablet

Routes of administration

Oral use

Dosage and administration details

BD intermittent 3 days on 4 days off schedule (Schedule A): AZD2014 (25 mg, 50 mg and 75 mg)

Investigational medicinal product name

Paclitaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate and solvent for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

BD intermittent 3 days on 4 days off schedule (Schedule A): paclitaxel (80mg/m2) intravenously every week (D1, D8, D15, D22, D29, D36) for 6 weeks followed by a 1 week break (1 cycle).

Number of subjects in period 1	Escalation: 3 days on, 4 days off (Schedule A)	Escalation: 2 days on, 5 days off (Schedule B)	Expansion: 3 days on, 4 days off (Schedule A)
Started	12	11	74
Completed	11	10	69
Not completed	1	1	5
Physician decision	1	1	2
Adverse event, non-fatal	-	-	2
Protocol deviation	-	-	1

Baseline characteristics

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Reporting group title

Treatment

Reporting group description

Reporting group values	Treatment	Total
Number of subjects	97	97
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	49	49
From 65-84 years	47	47
85 years and over	1	1
Gender categorical
Units: Subjects
Female	65	65
Male	32	32

End points

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Reporting group title

Escalation: 3 days on, 4 days off (Schedule A)

Reporting group description

Reporting group title

Escalation: 2 days on, 5 days off (Schedule B)

Reporting group description

Reporting group title

Expansion: 3 days on, 4 days off (Schedule A)

Reporting group description

Primary: To determine a dose at which no more than one patient out of up to six patients at the same dose level experience a drug-related DLT

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End point title

To determine a dose at which no more than one patient out of up to six patients at the same dose level experience a drug-related DLT ^[1] ^[2]

End point description

End point type

Primary

End point timeframe

28 days

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was required when assessing the number of DLTs. The Safety Review Committee made the decision to escalate the dose of AZD2014 maximum tolerated dose), thereby assessing the safest schedule to take forward into expansion.
[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: Patient disposition arms presented as: Escalation: 3d on, 4d off (Sch. A) Escalation: 2d on, 5d off (Sch. B) Expansion: 3d on, 4d off (Sch. A) AE's and SAE's the arms are split further into each schedule dosing groups and the expansion in the tumour types (Lung 25mg & 50mg and Ovarian 50mg): Escalation 3/4 25mg Escalation 3/4 50mg Escalation 3/4 75mg Escalation 2/5 50mg Escalation 2/5 75mg Escalation 2/5 100mg Ovarian expansion 50mg Lung expansion 25mg Lung expansion 50mg

End point values	Escalation: 3 days on, 4 days off (Schedule A)	Escalation: 2 days on, 5 days off (Schedule B)
Number of subjects analysed	11	10
Units: DLT
number (not applicable)	2	2

No statistical analyses for this end point

Primary: To determine causality of each adverse event to the combination of AZD2014 and weekly paclitaxel and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

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End point title

To determine causality of each adverse event to the combination of AZD2014 and weekly paclitaxel and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. ^[3] ^[4]

End point description

End point type

Primary

End point timeframe

From treatment.

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was required for this endpoint as the n number per each AE is not significant.
[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: Patient disposition arms presented as: Escalation: 3d on, 4d off (Sch. A) Escalation: 2d on, 5d off (Sch. B) Expansion: 3d on, 4d off (Sch. A) AE's and SAE's the arms are split further into each schedule dosing groups and the expansion in the tumour types (Lung 25mg & 50mg and Ovarian 50mg): Escalation 3/4 25mg Escalation 3/4 50mg Escalation 3/4 75mg Escalation 2/5 50mg Escalation 2/5 75mg Escalation 2/5 100mg Ovarian expansion 50mg Lung expansion 25mg Lung expansion 50mg

End point values	Escalation: 3 days on, 4 days off (Schedule A)	Escalation: 2 days on, 5 days off (Schedule B)
Number of subjects analysed	11	10
Units: Treatment related AE's
number (not applicable)	11	10

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Timeframe for AE

Adverse event reporting additional description

AE additional description

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Ovarian expansion 50mg

Reporting group description

Reporting group title

Lung expansion 50mg

Reporting group description

Reporting group title

Escalation 3/4 50mg

Reporting group description

Reporting group title

Escalation 3/4 25mg

Reporting group description

Reporting group title

Lung expansion 25mg

Reporting group description

Reporting group title

Escalation 2/5 100mg

Reporting group description

Reporting group title

Escalation 3/4 75mg

Reporting group description

Reporting group title

Escalation 2/5 75mg

Reporting group description

Reporting group title

Escalation 2/5 50mg

Reporting group description

Serious adverse events	Ovarian expansion 50mg	Lung expansion 50mg	Escalation 3/4 50mg	Escalation 3/4 25mg	Lung expansion 25mg	Escalation 2/5 100mg	Escalation 3/4 75mg	Escalation 2/5 75mg	Escalation 2/5 50mg
Total subjects affected by serious adverse events
subjects affected / exposed	17 / 27 (62.96%)	10 / 17 (58.82%)	3 / 6 (50.00%)	1 / 3 (33.33%)	12 / 24 (50.00%)	3 / 3 (100.00%)	2 / 3 (66.67%)	3 / 6 (50.00%)	1 / 1 (100.00%)
number of deaths (all causes)	1	3	0	0	2	0	0	0	0
number of deaths resulting from adverse events	0	1	0	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
Additional description: Ovarian epithelial cancer
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of skin
Additional description: Squamous cell carcinoma of skin
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypotension
Additional description: Hypotension
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphoedema
Additional description: Lymphoedema
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Superior vena cava syndrome
Additional description: Superior vena cava syndrome
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Disease progression
Additional description: Disease progression
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fatigue
Additional description: Fatigue
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oedema peripheral
Additional description: Oedema peripheral
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
Additional description: Pyrexia
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
Additional description: Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea
Additional description: Dyspnoea
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemoptysis
Additional description: Haemoptysis
subjects affected / exposed	0 / 27 (0.00%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
Additional description: Lower respiratory tract infection
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pleural effusion
Additional description: Pleural effusion
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonitis
Additional description: Pneumonitis
subjects affected / exposed	1 / 27 (3.70%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumothorax
Additional description: Pneumothorax
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	1 / 6 (16.67%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary oedema
Additional description: Pulmonary oedema
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory tract infection
Additional description: Respiratory tract infection
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Pulmonary function test decreased
Additional description: Pulmonary function test decreased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fall
Additional description: Fall
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Myocardial infarction
Additional description: Myocardial infarction
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
Additional description: Cerebrovascular accident
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Confusional state
Additional description: Confusional state
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spinal cord compression
Additional description: Spinal cord compression
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Febrile neutropenia
Additional description: Febrile neutropenia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Ascites
Additional description: Ascites
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Constipation
Additional description: Constipation
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
Additional description: Diarrhoea
subjects affected / exposed	3 / 27 (11.11%)	1 / 17 (5.88%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	2 / 3	1 / 1	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal toxicity
Additional description: Gastrointestinal toxicity
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
Additional description: Intestinal obstruction
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal perforation
Additional description: Intestinal perforation
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
Additional description: Small intestinal obstruction
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stomatitis
Additional description: Stomatitis
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Rash macular
Additional description: Rash macular
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rash maculo-papular
Additional description: Rash maculo-papular
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	2 / 3 (66.67%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchitis
Additional description: Bronchitis
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
Additional description: Cellulitis
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Device related sepsis
Additional description: Device related sepsis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocarditis
Additional description: Endocarditis
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
Additional description: Influenza
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
Additional description: Lower respiratory tract infection
subjects affected / exposed	3 / 27 (11.11%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	6 / 24 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	3 / 4	0 / 1	0 / 0	0 / 0	3 / 8	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Periorbital cellulitis
Additional description: Periorbital cellulitis
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
Additional description: Pneumonia
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
Additional description: Sepsis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
Additional description: Urinary tract infection
subjects affected / exposed	1 / 27 (3.70%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
Additional description: Dehydration
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypomagnesaemia
Additional description: Hypomagnesaemia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyponatraemia
Additional description: Hyponatraemia
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Ovarian expansion 50mg	Lung expansion 50mg	Escalation 3/4 50mg	Escalation 3/4 25mg	Lung expansion 25mg	Escalation 2/5 100mg	Escalation 3/4 75mg	Escalation 2/5 75mg	Escalation 2/5 50mg
Total subjects affected by non serious adverse events
subjects affected / exposed	27 / 27 (100.00%)	17 / 17 (100.00%)	6 / 6 (100.00%)	3 / 3 (100.00%)	24 / 24 (100.00%)	3 / 3 (100.00%)	3 / 3 (100.00%)	6 / 6 (100.00%)	1 / 1 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acral lentiginous melanoma
Additional description: Acral lentiginous melanoma
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Vascular disorders
Flushing
Additional description: Flushing
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Hot flush
Additional description: Hot flush
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Hypertension
Additional description: Hypertension
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0
Hypotension
Additional description: Hypotension
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	1	0	1	0
Lymphoedema
Additional description: Lymphoedema
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0
Orthostatic hypotension
Additional description: Orthostatic hypotension
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Post thrombotic syndrome
Additional description: Post thrombotic syndrome
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Superior vena cava syndrome
Additional description: Superior vena cava syndrome
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Surgical and medical procedures
Dry skin prophylaxis
Additional description: Dry skin prophylaxis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Asthenia
Additional description: Asthenia
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0
Chest pain
Additional description: Chest pain
subjects affected / exposed	1 / 27 (3.70%)	2 / 17 (11.76%)	0 / 6 (0.00%)	1 / 3 (33.33%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	6	0	1	1	0	0	0	0
Device related infection
Additional description: Device related infection
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Early satiety
Additional description: Early satiety
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Extravasation
Additional description: Extravasation
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Face oedema
Additional description: Face oedema
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Facial pain
Additional description: Facial pain
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Fatigue
Additional description: Fatigue
subjects affected / exposed	20 / 27 (74.07%)	13 / 17 (76.47%)	5 / 6 (83.33%)	3 / 3 (100.00%)	11 / 24 (45.83%)	3 / 3 (100.00%)	3 / 3 (100.00%)	4 / 6 (66.67%)	1 / 1 (100.00%)
occurrences all number	65	47	14	4	27	7	15	16	1
Influenza like illness
Additional description: Influenza like illness
subjects affected / exposed	3 / 27 (11.11%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	0	0	0	0	0	0	0	0
Localised oedema
Additional description: Localised oedema
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0
Malaise
Additional description: Malaise
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Mass
Additional description: Mass
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Mucosal inflammation
Additional description: Mucosal inflammation
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Non-cardiac chest pain
Additional description: Non-cardiac chest pain
subjects affected / exposed	1 / 27 (3.70%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0	0
Oedema
Additional description: Oedema
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Oedema peripheral
Additional description: Oedema peripheral
subjects affected / exposed	4 / 27 (14.81%)	3 / 17 (17.65%)	1 / 6 (16.67%)	1 / 3 (33.33%)	4 / 24 (16.67%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	6	6	2	2	9	0	0	1	0
Pain
Additional description: Pain
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Peripheral swelling
Additional description: Peripheral swelling
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Pyrexia
Additional description: Pyrexia
subjects affected / exposed	14 / 27 (51.85%)	6 / 17 (35.29%)	3 / 6 (50.00%)	0 / 3 (0.00%)	5 / 24 (20.83%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	20	7	4	0	5	0	0	0	0
Suprapubic pain
Additional description: Suprapubic pain
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Thirst
Additional description: Thirst
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Immune system disorders
Hypersensitivity
Additional description: Hypersensitivity
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	1	0	0	1	0	0	2	0
Seasonal allergy
Additional description: Seasonal allergy
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0
Reproductive system and breast disorders
Breast haemorrhage
Additional description: Breast haemorrhage
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Perineal pain
Additional description: Perineal pain
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Vaginal discharge
Additional description: Vaginal discharge
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0
Vaginal haemorrhage
Additional description: Vaginal haemorrhage
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Vaginal inflammation
Additional description: Vaginal inflammation
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0	0
Vulvovaginal discomfort
Additional description: Vulvovaginal discomfort
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
Additional description: Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Cough
Additional description: Cough
subjects affected / exposed	8 / 27 (29.63%)	9 / 17 (52.94%)	1 / 6 (16.67%)	0 / 3 (0.00%)	7 / 24 (29.17%)	2 / 3 (66.67%)	1 / 3 (33.33%)	2 / 6 (33.33%)	0 / 1 (0.00%)
occurrences all number	11	16	1	0	7	4	2	2	0
Dry throat
Additional description: Dry throat
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Dysphonia
Additional description: Dysphonia
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	2	0	0	1	0
Dyspnoea
Additional description: Dyspnoea
subjects affected / exposed	2 / 27 (7.41%)	9 / 17 (52.94%)	2 / 6 (33.33%)	1 / 3 (33.33%)	8 / 24 (33.33%)	3 / 3 (100.00%)	1 / 3 (33.33%)	2 / 6 (33.33%)	0 / 1 (0.00%)
occurrences all number	2	18	2	1	15	8	1	3	0
Dyspnoea exertional
Additional description: Dyspnoea exertional
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	1	0	1	0	0
Epistaxis
Additional description: Epistaxis
subjects affected / exposed	6 / 27 (22.22%)	2 / 17 (11.76%)	1 / 6 (16.67%)	0 / 3 (0.00%)	4 / 24 (16.67%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	7	4	1	0	7	0	1	1	0
Haemoptysis
Additional description: Haemoptysis
subjects affected / exposed	0 / 27 (0.00%)	3 / 17 (17.65%)	0 / 6 (0.00%)	1 / 3 (33.33%)	5 / 24 (20.83%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	3	0	1	7	0	0	0	0
Hypoxia
Additional description: Hypoxia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0
Laryngospasm
Additional description: Laryngospasm
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Nasal congestion
Additional description: Nasal congestion
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	4	1	0	0	1	0	0	0	0
Nasal discomfort
Additional description: Nasal discomfort
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Oropharyngeal pain
Additional description: Oropharyngeal pain
subjects affected / exposed	4 / 27 (14.81%)	2 / 17 (11.76%)	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	5	2	3	0	1	0	0	1	0
Pneumonitis
Additional description: Pneumonitis
subjects affected / exposed	2 / 27 (7.41%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	2	0	0	2	0	0	0	0
Productive cough
Additional description: Productive cough
subjects affected / exposed	2 / 27 (7.41%)	2 / 17 (11.76%)	2 / 6 (33.33%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	1 / 3 (33.33%)	3 / 6 (50.00%)	0 / 1 (0.00%)
occurrences all number	3	2	6	0	1	0	1	3	0
Rhinorrhoea
Additional description: Rhinorrhoea
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	2 / 3 (66.67%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	1	2	0	1	0
Stridor
Additional description: Stridor
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Upper-airway cough syndrome
Additional description: Upper-airway cough syndrome
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Upper respiratory tract congestion
Additional description: Upper respiratory tract congestion
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Wheezing
Additional description: Wheezing
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	3	0	0	0	0
Psychiatric disorders
Anxiety
Additional description: Anxiety
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Depressed mood
Additional description: Depressed mood
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	0
Depression
Additional description: Depression
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Hallucination
Additional description: Hallucination
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Insomnia
Additional description: Insomnia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	2 / 24 (8.33%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	2	1	0	0	0
Nightmare
Additional description: Nightmare
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Investigations
Alanine aminotransferase increased
Additional description: Alanine aminotransferase increased
subjects affected / exposed	1 / 27 (3.70%)	1 / 17 (5.88%)	1 / 6 (16.67%)	1 / 3 (33.33%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	3	1	1	2	0	0	0	0
Aspartate aminotransferase increased
Additional description: Aspartate aminotransferase increased
subjects affected / exposed	1 / 27 (3.70%)	1 / 17 (5.88%)	1 / 6 (16.67%)	1 / 3 (33.33%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	2	2	1	1	0	0	0	0
Blood alkaline phosphatase increased
Additional description: Blood alkaline phosphatase increased
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0
Blood creatinine increased
Additional description: Blood creatinine increased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	4 / 24 (16.67%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 6 (33.33%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	7	0	0	4	0
Blood glucose increased
Additional description: Blood glucose increased
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	2	0	3	0	0
Blood magnesium increased
Additional description: Blood magnesium increased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0
Blood phosphorus decreased
Additional description: Blood phosphorus decreased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Blood potassium decreased
Additional description: Blood potassium decreased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Blood potassium increased
Additional description: Blood potassium increased
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0
Blood sodium decreased
Additional description: Blood sodium decreased
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Blood triglycerides increased
Additional description: Blood triglycerides increased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0
Blood urea increased
Additional description: Blood urea increased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0
CD4 lymphocytes decreased
Additional description: CD4 lymphocytes decreased
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	6	0	0	0	0	0	0	0	0
Gamma-glutamyltransferase increased
Additional description: Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 6 (16.67%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	4	0	0	0	0	0
Haemoglobin decreased
Additional description: Haemoglobin decreased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Liver function test abnormal
Additional description: Liver function test abnormal
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0
Neutrophil count decreased
Additional description: Neutrophil count decreased
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	3	0	0	0	0
Neutrophil count increased
Additional description: Neutrophil count increased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Weight decreased
Additional description: Weight decreased
subjects affected / exposed	5 / 27 (18.52%)	4 / 17 (23.53%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	8	5	0	0	2	0	1	1	0
Weight increased
Additional description: Weight increased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
White blood cell count decreased
Additional description: White blood cell count decreased
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	4 / 24 (16.67%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	4	0	0	0	17	0	0	0	0
White blood cell count increased
Additional description: White blood cell count increased
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Injury, poisoning and procedural complications
Contusion
Additional description: Contusion
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0
Cystitis radiation
Additional description: Cystitis radiation
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Fall
Additional description: Fall
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0
Infusion related reaction
Additional description: Infusion related reaction
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Pneumonitis chemical
Additional description: Pneumonitis chemical
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Procedural pain
Additional description: Procedural pain
subjects affected / exposed	1 / 27 (3.70%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	0	0	0	0	1	0	0
Skin injury
Additional description: Skin injury
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Wound
Additional description: Wound
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	3	0	0	0	0
Congenital, familial and genetic disorders
Hand-foot-genital syndrome
Additional description: Hand-foot-genital syndrome
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0
Cardiac disorders
Atrial fibrillation
Additional description: Atrial fibrillation
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Atrial flutter
Additional description: Atrial flutter
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Atrial tachycardia
Additional description: Atrial tachycardia
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Palpitations
Additional description: Palpitations
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0
Sinus tachycardia
Additional description: Sinus tachycardia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Supraventricular tachycardia
Additional description: Supraventricular tachycardia
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Tachycardia
Additional description: Tachycardia
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	1	0	1	0	0
Nervous system disorders
Amnesia
Additional description: Amnesia
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Aphasia
Additional description: Aphasia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Ataxia
Additional description: Ataxia
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Cluster headache
Additional description: Cluster headache
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Cognitive disorder
Additional description: Cognitive disorder
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Confusional state
Additional description: Confusional state
subjects affected / exposed	0 / 27 (0.00%)	2 / 17 (11.76%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	2	0	1	0	0	0	1	0
Dizziness
Additional description: Dizziness
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	1	0	0	1	1	0	0	0
Dizziness postural
Additional description: Dizziness postural
subjects affected / exposed	3 / 27 (11.11%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	2	0	0	1	0	0	0	0
Dysgeusia
Additional description: Dysgeusia
subjects affected / exposed	4 / 27 (14.81%)	2 / 17 (11.76%)	4 / 6 (66.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	4 / 6 (66.67%)	0 / 1 (0.00%)
occurrences all number	6	4	4	0	0	0	1	4	0
Headache
Additional description: Headache
subjects affected / exposed	1 / 27 (3.70%)	1 / 17 (5.88%)	1 / 6 (16.67%)	0 / 3 (0.00%)	3 / 24 (12.50%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	1	0	4	0	0	0	0
Hypoaesthesia
Additional description: Hypoaesthesia
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0
Hypokinesia
Additional description: Hypokinesia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Lethargy
Additional description: Lethargy
subjects affected / exposed	0 / 27 (0.00%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	4 / 24 (16.67%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	2	0	0	5	0	0	0	0
Migraine
Additional description: Migraine
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0
Neuropathy peripheral
Additional description: Neuropathy peripheral
subjects affected / exposed	9 / 27 (33.33%)	5 / 17 (29.41%)	3 / 6 (50.00%)	2 / 3 (66.67%)	9 / 24 (37.50%)	2 / 3 (66.67%)	1 / 3 (33.33%)	3 / 6 (50.00%)	0 / 1 (0.00%)
occurrences all number	13	10	3	2	11	2	1	6	0
Neurotoxicity
Additional description: Neurotoxicity
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	2 / 6 (33.33%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	3	0	0	0	0	0	0
Paraesthesia
Additional description: Paraesthesia
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	1 / 6 (16.67%)	1 / 3 (33.33%)	1 / 24 (4.17%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	2	1	3	0	1	0	0
Peripheral motor neuropathy
Additional description: Peripheral motor neuropathy
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Peripheral sensory neuropathy
Additional description: Peripheral sensory neuropathy
subjects affected / exposed	3 / 27 (11.11%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	5	1	0	0	2	0	0	0	0
Presyncope
Additional description: Presyncope
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	1	0	0	0	0
Restless legs syndrome
Additional description: Restless legs syndrome
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Somnolence
Additional description: Somnolence
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Trigeminal nerve disorder
Additional description: Trigeminal nerve disorder
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Anaemia
Additional description: Anaemia
subjects affected / exposed	10 / 27 (37.04%)	5 / 17 (29.41%)	5 / 6 (83.33%)	3 / 3 (100.00%)	14 / 24 (58.33%)	1 / 3 (33.33%)	2 / 3 (66.67%)	2 / 6 (33.33%)	0 / 1 (0.00%)
occurrences all number	18	13	13	9	26	2	4	5	0
Blood disorder
Additional description: Blood disorder
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Bone marrow failure
Additional description: Bone marrow failure
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Febrile neutropenia
Additional description: Febrile neutropenia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Leukopenia
Additional description: Leukopenia
subjects affected / exposed	0 / 27 (0.00%)	3 / 17 (17.65%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	12	1	0	0	0	0	0	0
Lymphopenia
Additional description: Lymphopenia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	1	0	0	2	0	0
Neutropenia
Additional description: Neutropenia
subjects affected / exposed	8 / 27 (29.63%)	4 / 17 (23.53%)	3 / 6 (50.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	1 / 3 (33.33%)	3 / 3 (100.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	20	8	12	0	7	1	3	0	0
Thrombocytopenia
Additional description: Thrombocytopenia
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	4	0	0	0	0	0	0	1	0
Ear and labyrinth disorders
Vertigo
Additional description: Vertigo
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Eye disorders
Blepharitis
Additional description: Blepharitis
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Dry eye
Additional description: Dry eye
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Eye discharge
Additional description: Eye discharge
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Eye pain
Additional description: Eye pain
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Foreign body sensation in eyes
Additional description: Foreign body sensation in eyes
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Lacrimation increased
Additional description: Lacrimation increased
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0
Gastrointestinal disorders
Abdominal discomfort
Additional description: Abdominal discomfort
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	1	3	0	0	0	0	1	0
Abdominal distension
Additional description: Abdominal distension
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	0	1	0	0	1	0	2	0
Abdominal mass
Additional description: Abdominal mass
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Abdominal pain
Additional description: Abdominal pain
subjects affected / exposed	7 / 27 (25.93%)	1 / 17 (5.88%)	2 / 6 (33.33%)	1 / 3 (33.33%)	1 / 24 (4.17%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 6 (16.67%)	1 / 1 (100.00%)
occurrences all number	17	1	2	1	1	1	0	1	4
Abdominal pain lower
Additional description: Abdominal pain lower
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Abdominal pain upper
Additional description: Abdominal pain upper
subjects affected / exposed	1 / 27 (3.70%)	2 / 17 (11.76%)	1 / 6 (16.67%)	0 / 3 (0.00%)	2 / 24 (8.33%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	2	1	0	2	1	0	0	0
Anorectal discomfort
Additional description: Anorectal discomfort
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Aphthous ulcer
Additional description: Aphthous ulcer
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Ascites
Additional description: Ascites
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	0	0	0	1	0
Constipation
Additional description: Constipation
subjects affected / exposed	12 / 27 (44.44%)	5 / 17 (29.41%)	3 / 6 (50.00%)	1 / 3 (33.33%)	1 / 24 (4.17%)	1 / 3 (33.33%)	1 / 3 (33.33%)	1 / 6 (16.67%)	1 / 1 (100.00%)
occurrences all number	24	10	8	1	1	7	1	1	1
Diarrhoea
Additional description: Diarrhoea
subjects affected / exposed	16 / 27 (59.26%)	9 / 17 (52.94%)	5 / 6 (83.33%)	2 / 3 (66.67%)	9 / 24 (37.50%)	2 / 3 (66.67%)	2 / 3 (66.67%)	3 / 6 (50.00%)	0 / 1 (0.00%)
occurrences all number	58	22	18	3	17	15	12	11	0
Dry mouth
Additional description: Dry mouth
subjects affected / exposed	5 / 27 (18.52%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	9	2	0	0	1	1	1	0	0
Duodenogastric reflux
Additional description: Duodenogastric reflux
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	0	1	1	0	0	0	1
Dyspepsia
Additional description: Dyspepsia
subjects affected / exposed	8 / 27 (29.63%)	2 / 17 (11.76%)	1 / 6 (16.67%)	0 / 3 (0.00%)	5 / 24 (20.83%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	9	2	3	0	8	0	0	3	0
Epigastric discomfort
Additional description: Epigastric discomfort
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Eructation
Additional description: Eructation
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Flatulence
Additional description: Flatulence
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	1	0	0	0	0
Gastrooesophageal reflux disease
Additional description: Gastrooesophageal reflux disease
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	2 / 3 (66.67%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	1	2	0	0	0
Haemorrhoids
Additional description: Haemorrhoids
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Mouth ulceration
Additional description: Mouth ulceration
subjects affected / exposed	3 / 27 (11.11%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	3 / 24 (12.50%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	5	0	0	3	0	0	0	0
Nausea
Additional description: Nausea
subjects affected / exposed	12 / 27 (44.44%)	5 / 17 (29.41%)	4 / 6 (66.67%)	3 / 3 (100.00%)	11 / 24 (45.83%)	2 / 3 (66.67%)	0 / 3 (0.00%)	5 / 6 (83.33%)	1 / 1 (100.00%)
occurrences all number	23	11	11	4	20	14	0	7	3
Oral pain
Additional description: Oral pain
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Paraesthesia oral
Additional description: Paraesthesia oral
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Proctalgia
Additional description: Proctalgia
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Sensitivity of teeth
Additional description: Sensitivity of teeth
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Stomatitis
Additional description: Stomatitis
subjects affected / exposed	8 / 27 (29.63%)	3 / 17 (17.65%)	2 / 6 (33.33%)	1 / 3 (33.33%)	4 / 24 (16.67%)	0 / 3 (0.00%)	2 / 3 (66.67%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	19	3	2	1	5	0	7	1	0
Vomiting
Additional description: Vomiting
subjects affected / exposed	12 / 27 (44.44%)	6 / 17 (35.29%)	1 / 6 (16.67%)	0 / 3 (0.00%)	4 / 24 (16.67%)	1 / 3 (33.33%)	1 / 3 (33.33%)	2 / 6 (33.33%)	1 / 1 (100.00%)
occurrences all number	24	9	1	0	5	13	1	2	5
Hepatobiliary disorders
Hyperbilirubinaemia
Additional description: Hyperbilirubinaemia
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Alopecia
Additional description: Alopecia
subjects affected / exposed	8 / 27 (29.63%)	2 / 17 (11.76%)	4 / 6 (66.67%)	1 / 3 (33.33%)	14 / 24 (58.33%)	0 / 3 (0.00%)	2 / 3 (66.67%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	8	2	10	2	21	0	4	1	0
Dermatitis acneiform
Additional description: Dermatitis acneiform
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 6 (33.33%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	2	0	1	2	0
Dermatitis
Additional description: Dermatitis
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	0	2	0	0	0	0	1	0
Dermatitis contact
Additional description: Dermatitis contact
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Dry skin
Additional description: Dry skin
subjects affected / exposed	2 / 27 (7.41%)	5 / 17 (29.41%)	1 / 6 (16.67%)	1 / 3 (33.33%)	4 / 24 (16.67%)	0 / 3 (0.00%)	2 / 3 (66.67%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	6	1	2	5	0	4	1	0
Eczema
Additional description: Eczema
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	0	0	0	0	0	0	0	0
Erythema
Additional description: Erythema
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	2 / 3 (66.67%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	1	0	0	1	2	0	1	0
Henoch-Schonlein purpura
Additional description: Henoch-Schonlein purpura
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Hyperhidrosis
Additional description: Hyperhidrosis
subjects affected / exposed	1 / 27 (3.70%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0	0
Nail discolouration
Additional description: Nail discolouration
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	3 / 24 (12.50%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	3	0	0	1	0
Nail disorder
Additional description: Nail disorder
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Nail dystrophy
Additional description: Nail dystrophy
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Nail growth abnormal
Additional description: Nail growth abnormal
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Nail ridging
Additional description: Nail ridging
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0
Onychoclasis
Additional description: Onychoclasis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	2	0	0	0	0	0	0
Onycholysis
Additional description: Onycholysis
subjects affected / exposed	3 / 27 (11.11%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	1	0	0	0	0	0	0	0
Onychomadesis
Additional description: Onychomadesis
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Palmar-plantar erythrodysaesthesia syndrome
Additional description: Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Pigmentation disorder
Additional description: Pigmentation disorder
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Pruritus
Additional description: Pruritus
subjects affected / exposed	3 / 27 (11.11%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	3 / 24 (12.50%)	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 6 (33.33%)	0 / 1 (0.00%)
occurrences all number	5	0	0	1	3	0	1	6	0
Rash
Additional description: Rash
subjects affected / exposed	8 / 27 (29.63%)	4 / 17 (23.53%)	1 / 6 (16.67%)	0 / 3 (0.00%)	6 / 24 (25.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	26	8	2	0	8	2	2	0	0
Rash macular
Additional description: Rash macular
subjects affected / exposed	6 / 27 (22.22%)	2 / 17 (11.76%)	0 / 6 (0.00%)	1 / 3 (33.33%)	2 / 24 (8.33%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	14	4	0	1	2	2	0	1	0
Rash maculo-papular
Additional description: Rash maculo-papular
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	4	1	0	0	0	0	0	0	0
Rash pruritic
Additional description: Rash pruritic
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Rash vesicular
Additional description: Rash vesicular
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Skin discolouration
Additional description: Skin discolouration
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Skin induration
Additional description: Skin induration
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Skin irritation
Additional description: Skin irritation
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Skin lesion
Additional description: Skin lesion
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0
Skin ulcer
Additional description: Skin ulcer
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	2	0	0	0	0
Stasis dermatitis
Additional description: Stasis dermatitis
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Urticaria
Additional description: Urticaria
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	4	0
Renal and urinary disorders
Dysuria
Additional description: Dysuria
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Haematuria
Additional description: Haematuria
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Pollakiuria
Additional description: Pollakiuria
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0
Urinary incontinence
Additional description: Urinary incontinence
subjects affected / exposed	1 / 27 (3.70%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0	0
Urinary retention
Additional description: Urinary retention
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
Additional description: Arthralgia
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	2 / 6 (33.33%)	0 / 3 (0.00%)	4 / 24 (16.67%)	1 / 3 (33.33%)	1 / 3 (33.33%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	1	2	0	5	5	1	2	0
Back pain
Additional description: Back pain
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	1 / 6 (16.67%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	1	1	0	2	0	0	1	0
Groin pain
Additional description: Groin pain
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Joint swelling
Additional description: Joint swelling
subjects affected / exposed	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Limb discomfort
Additional description: Limb discomfort
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0
Muscle spasms
Additional description: Muscle spasms
subjects affected / exposed	4 / 27 (14.81%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	5	2	0	0	0	0	0	0	0
Muscle twitching
Additional description: Muscle twitching
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Muscular weakness
Additional description: Muscular weakness
subjects affected / exposed	1 / 27 (3.70%)	3 / 17 (17.65%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	5	0	0	0	0	0	0	0
Musculoskeletal chest pain
Additional description: Musculoskeletal chest pain
subjects affected / exposed	0 / 27 (0.00%)	3 / 17 (17.65%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	3	0	1	0	0	0	0	0
Musculoskeletal pain
Additional description: Musculoskeletal pain
subjects affected / exposed	0 / 27 (0.00%)	2 / 17 (11.76%)	2 / 6 (33.33%)	0 / 3 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	4	2	0	1	2	0	0	0
Musculoskeletal stiffness
Additional description: Musculoskeletal stiffness
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Myalgia
Additional description: Myalgia
subjects affected / exposed	3 / 27 (11.11%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	5	1	0	0	2	1	0	1	0
Neck pain
Additional description: Neck pain
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0	0
Pain in extremity
Additional description: Pain in extremity
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0
Spinal pain
Additional description: Spinal pain
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Tendonitis
Additional description: Tendonitis
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Infections and infestations
Angular cheilitis
Additional description: Angular cheilitis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Bronchitis
Additional description: Bronchitis
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	2	0	0	0	0
Catheter site cellulitis
Additional description: Catheter site cellulitis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Cellulitis
Additional description: Cellulitis
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	5	1	0	0	3	0	0	1	0
Conjunctivitis
Additional description: Conjunctivitis
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0
Cystitis
Additional description: Cystitis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	3	0	0	0	0	0	0	2	0
Dermatitis infected
Additional description: Dermatitis infected
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Device related sepsis
Additional description: Device related sepsis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Ear infection fungal
Additional description: Ear infection fungal
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Gastroenteritis
Additional description: Gastroenteritis
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Genital herpes
Additional description: Genital herpes
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Herpes virus infection
Additional description: Herpes virus infection
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Localised infection
Additional description: Localised infection
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Lower respiratory tract infection
Additional description: Lower respiratory tract infection
subjects affected / exposed	3 / 27 (11.11%)	5 / 17 (29.41%)	1 / 6 (16.67%)	0 / 3 (0.00%)	10 / 24 (41.67%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	3	5	1	0	10	0	1	1	0
Lung infection
Additional description: Lung infection
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0
Nail infection
Additional description: Nail infection
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	0	1	0	0	0
Nasopharyngitis
Additional description: Nasopharyngitis
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0
Oral candidiasis
Additional description: Oral candidiasis
subjects affected / exposed	2 / 27 (7.41%)	5 / 17 (29.41%)	0 / 6 (0.00%)	0 / 3 (0.00%)	3 / 24 (12.50%)	1 / 3 (33.33%)	1 / 3 (33.33%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	5	0	0	3	1	2	1	0
Oral herpes
Additional description: Oral herpes
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	2	0	0
Oropharyngeal candidiasis
Additional description: Oropharyngeal candidiasis
subjects affected / exposed	0 / 27 (0.00%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0
Paronychia
Additional description: Paronychia
subjects affected / exposed	1 / 27 (3.70%)	2 / 17 (11.76%)	2 / 6 (33.33%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	1	2	3	0	0	0	0	3	0
Periorbital cellulitis
Additional description: Periorbital cellulitis
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Pneumonia
Additional description: Pneumonia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	1	0
Rash pustular
Additional description: Rash pustular
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	1	0	0	0	0	0	1	0
Respiratory tract infection
Additional description: Respiratory tract infection
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	0
Rhinitis
Additional description: Rhinitis
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	2	1	0	0	2	0	0	1	0
Tinea pedis
Additional description: Tinea pedis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 6 (16.67%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0
Upper respiratory tract infection
Additional description: Upper respiratory tract infection
subjects affected / exposed	4 / 27 (14.81%)	2 / 17 (11.76%)	2 / 6 (33.33%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 6 (33.33%)	0 / 1 (0.00%)
occurrences all number	7	2	2	0	3	0	2	2	0
Urinary tract infection
Additional description: Urinary tract infection
subjects affected / exposed	9 / 27 (33.33%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	17	1	0	0	1	3	0	0	0
Varicella zoster virus infection
Additional description: Varicella zoster virus infection
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0
Viral upper respiratory tract infection
Additional description: Viral upper respiratory tract infection
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	4	1	0	0	0	0	0	0	0
Vulvovaginal candidiasis
Additional description: Vulvovaginal candidiasis
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0	0
Metabolism and nutrition disorders
Decreased appetite
Additional description: Decreased appetite
subjects affected / exposed	5 / 27 (18.52%)	9 / 17 (52.94%)	3 / 6 (50.00%)	1 / 3 (33.33%)	6 / 24 (25.00%)	1 / 3 (33.33%)	2 / 3 (66.67%)	1 / 6 (16.67%)	1 / 1 (100.00%)
occurrences all number	6	17	3	1	9	1	2	2	1
Glucose tolerance impaired
Additional description: Glucose tolerance impaired
subjects affected / exposed	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	4	0	0	0	0	0	0	0
Hypercalcaemia
Additional description: Hypercalcaemia
subjects affected / exposed	0 / 27 (0.00%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0
Hyperglycaemia
Additional description: Hyperglycaemia
subjects affected / exposed	2 / 27 (7.41%)	3 / 17 (17.65%)	1 / 6 (16.67%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	6	7	1	0	1	0	1	0	0
Hyperkalaemia
Additional description: Hyperkalaemia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Hypoalbuminaemia
Additional description: Hypoalbuminaemia
subjects affected / exposed	2 / 27 (7.41%)	1 / 17 (5.88%)	0 / 6 (0.00%)	1 / 3 (33.33%)	0 / 24 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 6 (33.33%)	0 / 1 (0.00%)
occurrences all number	2	1	0	1	0	0	0	3	0
Hypokalaemia
Additional description: Hypokalaemia
subjects affected / exposed	4 / 27 (14.81%)	2 / 17 (11.76%)	0 / 6 (0.00%)	0 / 3 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)	2 / 3 (66.67%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	8	3	0	0	2	0	2	0	0
Hypomagnesaemia
Additional description: Hypomagnesaemia
subjects affected / exposed	5 / 27 (18.52%)	0 / 17 (0.00%)	2 / 6 (33.33%)	1 / 3 (33.33%)	1 / 24 (4.17%)	1 / 3 (33.33%)	2 / 3 (66.67%)	1 / 6 (16.67%)	0 / 1 (0.00%)
occurrences all number	8	0	3	2	1	2	2	2	0
Hyponatraemia
Additional description: Hyponatraemia
subjects affected / exposed	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 6 (0.00%)	1 / 3 (33.33%)	3 / 24 (12.50%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	1	3	0	0	0	0
Hypophagia
Additional description: Hypophagia
subjects affected / exposed	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 6 (0.00%)	0 / 3 (0.00%)	0 / 24 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	3	0	0
Hypophosphataemia
Additional description: Hypophosphataemia
subjects affected / exposed	1 / 27 (3.70%)	2 / 17 (11.76%)	2 / 6 (33.33%)	1 / 3 (33.33%)	2 / 24 (8.33%)	0 / 3 (0.00%)	3 / 3 (100.00%)	0 / 6 (0.00%)	0 / 1 (0.00%)
occurrences all number	4	2	2	1	6	0	6	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

14 May 2013

Am. 01: Changes to Protocol 7.2, 8.2.3 {10 ovarian pts / schedule for EXP}

10 Dec 2013

Am.02: change to schedules, 4.1.2.2, 5.5.1, {increase EXP ovarian on 3on/4off 10 +15}

06 Jun 2014

Am.03: added Guys 104, added 15 sq. lung, exclusion with CYP, 7.2 haem and biochem test, screening SAEs exempt {EXP 3on/4off = 10 ovarian + 15 lung, 2on/5off = 15 lung}

18 Dec 2014

Am.04: added 105, 106, 107, 108, 109 - seq of circulating free DNA (5) (8.3), {incr EXP sq. lung on 3on/4off from 15 to 40}

16 Apr 2015

Am.05: added buccal swabs and 2nd base blood

02 Nov 2015

Am.06: description of tumour inclusion increased, contraception inclusion removed in error AZD interruptions for pneumonitis

05 Feb 2016

Am.07: 4.1.1.5 contraception returned

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results:
TAX-TORC: A Phase I multi-centre trial of the combination of AZD2014 (dual TORC1 and TORC2 inhibitor) and weekly paclitaxel in patients with solid tumours

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: To determine a dose at which no more than one patient out of up to six patients at the same dose level experience a drug-related DLT

Primary: To determine a dose at which no more than one patient out of up to six patients at the same dose level experience a drug-related DLT

Primary: To determine causality of each adverse event to the combination of AZD2014 and weekly paclitaxel and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Primary: To determine causality of each adverse event to the combination of AZD2014 and weekly paclitaxel and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

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Clinical trials

Clinical Trial Results: TAX-TORC: A Phase I multi-centre trial of the combination of AZD2014 (dual TORC1 and TORC2 inhibitor) and weekly paclitaxel in patients with solid tumours

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: To determine a dose at which no more than one patient out of up to six patients at the same dose level experience a drug-related DLT

Primary: To determine a dose at which no more than one patient out of up to six patients at the same dose level experience a drug-related DLT

Primary: To determine causality of each adverse event to the combination of AZD2014 and weekly paclitaxel and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Primary: To determine causality of each adverse event to the combination of AZD2014 and weekly paclitaxel and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
TAX-TORC: A Phase I multi-centre trial of the combination of AZD2014 (dual TORC1 and TORC2 inhibitor) and weekly paclitaxel in patients with solid tumours