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Clinical Trial Results:
Simultaneous Study of Gemcitabine-Docetaxel Combination adjuvant treatment, as well as Biological Targeted Treatment SUCCESS B-Trial

Summary
EudraCT number	2007-001094-29
Trial protocol	DE
Global end of trial date	15 Mar 2015

Results information
Results version number	v1(current)
This version publication date	13 Aug 2022
First version publication date	13 Aug 2022
Other versions
Summary report(s)	20190626_SUCESS-B-trial_Study Report_signed

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

SUCCESS-B-Trail

ISRCTN number

US NCT number

NCT00670878

WHO universal trial number (UTN)

Sponsor organisation name

Klinikum der Universität München

Sponsor organisation address

Maistraße 11, Munich, Germany, 80337

Public contact

Prof. Sommer, Prof. Sommer, Poliklinik + Klinik für Frauenheilkunde + Geburtshilfe, Maistraße 11, Munich, Germany, +49 89 4400 54111, Harald.Sommer@med.uni-muenchen.de

Scientific contact

Prof. Sommer, Prof. Sommer, Poliklinik + Klinik für Frauenheilkunde + Geburtshilfe, Maistraße 11, Munich, Germany, +49 89 4400 54111, Harald.Sommer@med.uni-muenchen.de

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

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

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

Analysis stage

Final

Date of interim/final analysis

15 Nov 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 Mar 2015

Was the trial ended prematurely?

Main objective of the trial

Das primäre Studienziel ist der Vergleich der rezidivfreien Überlebenszeit nach Randomisierung von Patientinnen, die adjuvant 3 Zyklen Epirubicin-5-Fluorouracil-Cyclophosphamid(FEC)-Chemotherapie, gefolgt von 3 Zyklen Docetaxel (D)-Chemotherapie versus 3 Zyklen Epirubicin-5-Fluorouracil-Cyclophosphamid(FEC)-Chemotherapie, gefolgt von 3 Zyklen Gemcitabine-Docetaxel (DG)- Chemotherapie erhalten.

Protection of trial subjects

This study was conducted in compliance with Good Clinical Practice (GCP), including the archiving of essential documents.

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Jun 2008

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 793

Worldwide total number of subjects

793

EEA total number of subjects

793

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)

637

From 65 to 84 years

156

85 years and over

Subject disposition

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Recruitment details

Overall, 793 patients were randomized in the SUCCESS B trial. 395 patients were assigned to FEC-Doc chemotherapy and 398 patients were assigned to FEC-DocG chemotherapy.

Screening details

no pre-screening, no wash-out, no run-in

Period 1 title

overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

FEC-Doc

Arm description

3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22

Arm type

Active comparator

Investigational medicinal product name

Docetaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Infusion

Dosage and administration details

100 mg/m² body surface area i.v.

FEC-DocG

Arm description

3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (D), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (G), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22

Arm type

Experimental

Investigational medicinal product name

Docetaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Infusion

Dosage and administration details

75 mg/m² body surface area i.v.

Investigational medicinal product name

Gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Infusion

Dosage and administration details

1000 mg/m² i.v.

Number of subjects in period 1	FEC-Doc	FEC-DocG
Started	395	398
Completed	358	353
Not completed	37	45
Consent withdrawn by subject	13	12
unknown	3	6
Adverse event, non-fatal	15	16
did not receive any chemotherapy	6	9
Protocol deviation	-	2

Baseline characteristics

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Reporting group title

FEC-Doc

Reporting group description

Reporting group title

FEC-DocG

Reporting group description

3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (D), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (G), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22

Reporting group values	FEC-Doc	FEC-DocG	Total
Number of subjects	395	398	793
Age categorical
Units: Subjects
Adults (18-64 years)	316	321	637
From 65-84 years	79	77	156
85 years and over	0	0	0
Age continuous
FEC-Doc Age Mean 55.1 FEC-Doc Age SD 10.3% FEC-DocG Age Mean 54.4 FEC-DocG SD 10%
Units: years
arithmetic mean (standard deviation)	55.07 ( 10.292 )	54.44 ( 10.003 )	-
Gender categorical
Female only - early primary breast cancer patients
Units: Subjects
Female	395	398	793

Subject analysis set title

ITT

Subject analysis set type

Intention-to-treat

Subject analysis set description

This population includes all patients who gave informed consent to take part in this study AND who were randomized into one of the chemotherapy treatment arm (A or B). A total of 793 patients were included into this analysis.

Subject analysis set title

Safety Population

Subject analysis set type

Safety analysis

Subject analysis set description

defined as all patients who were treated with at least one cycle of FEC chemotherapy (n=778)

Subject analysis sets values	ITT	Safety Population
Number of subjects	793	778
Age categorical
Units: Subjects
Adults (18-64 years)	637
From 65-84 years	156
85 years and over	0
Age continuous
FEC-Doc Age Mean 55.1 FEC-Doc Age SD 10.3% FEC-DocG Age Mean 54.4 FEC-DocG SD 10%
Units: years
arithmetic mean (standard deviation)	54.75 ( 10.146 )	( )
Gender categorical
Female only - early primary breast cancer patients
Units: Subjects
Female	793	778

End points

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Reporting group title

FEC-Doc

Reporting group description

Reporting group title

FEC-DocG

Reporting group description

3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (D), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (G), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22

Subject analysis set title

ITT

Subject analysis set type

Intention-to-treat

Subject analysis set description

Subject analysis set title

Safety Population

Subject analysis set type

Safety analysis

Subject analysis set description

defined as all patients who were treated with at least one cycle of FEC chemotherapy (n=778)

Primary: DFS

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End point title

DFS

End point description

compare the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil- Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)- chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)-chemotherapy, both arms followed by biological anti-HER2 treatment respectively

End point type

Primary

End point timeframe

five years

End point values	FEC-Doc	FEC-DocG	ITT
Number of subjects analysed	395	398	793
Units: event	27	26	53

Comparison of DFS between the two study arms

Comparison groups

FEC-DocG v FEC-Doc

Number of subjects included in analysis

793

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.97

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.58

upper limit

1.7

Adverse events

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Timeframe for reporting adverse events

For the safety evaluation, all adverse events observed within cycles 1 to 6 of the cytostatic treatments were analyzed

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

FEC-Doc

Reporting group description

3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (D), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (G), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22

Reporting group title

FEC-DocG

Reporting group description

Serious adverse events	FEC-Doc	FEC-DocG
Total subjects affected by serious adverse events
subjects affected / exposed	103 / 395 (26.08%)	124 / 398 (31.16%)
number of deaths (all causes)	14	16
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Metastases to liver
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to lung
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lymph nodes
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spine
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Neoplasm progression
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Second primary malignancy
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Uterine cancer
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Circulatory collapse
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	1 / 1	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism
subjects affected / exposed	2 / 395 (0.51%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hypertension
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian vein thrombosis
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	5 / 395 (1.27%)	4 / 398 (1.01%)
occurrences causally related to treatment / all	2 / 5	2 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Hypotension
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Breast operation
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast prosthesis implantation
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast reconstruction
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hip surgery
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mammoplasty
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mastectomy
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device implantation
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device removal
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian operation
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroidectomy
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chills
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disease progression
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Fatigue
subjects affected / exposed	2 / 395 (0.51%)	6 / 398 (1.51%)
occurrences causally related to treatment / all	2 / 2	6 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	4 / 395 (1.01%)	11 / 398 (2.76%)
occurrences causally related to treatment / all	4 / 5	12 / 14
deaths causally related to treatment / all	0 / 0	0 / 1
Impaired healing
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mucosal inflammation
subjects affected / exposed	1 / 395 (0.25%)	5 / 398 (1.26%)
occurrences causally related to treatment / all	1 / 1	5 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Necrosis
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Performance status decreased
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	9 / 395 (2.28%)	15 / 398 (3.77%)
occurrences causally related to treatment / all	9 / 9	6 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden death
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Immune system disorders
Hypersensitivity
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Breast mass
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Menorrhagia
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Alveolitis
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial hyperreactivity
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	2 / 395 (0.51%)	5 / 398 (1.26%)
occurrences causally related to treatment / all	1 / 2	5 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infiltration
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary congestion
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 395 (0.25%)	4 / 398 (1.01%)
occurrences causally related to treatment / all	1 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary infarction
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheal inflammation
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Anxiety
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fear
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mood altered
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device malfunction
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis in device
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Alanine aminotransferase
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
C-reactive protein increased
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction decreased
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Granulocytes abnormal
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutrophil count
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
White blood cell count increased
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fracture
subjects affected / exposed	3 / 395 (0.76%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seroma
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suture related complication
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound complication
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Angina pectoris
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia supraventricular
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular dysfunction
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	1 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nodal arrhythmia
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tachyarrhythmia
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia paroxysmal
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences causally related to treatment / all	1 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lethargy
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasticity
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuralgia
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Speech disorder
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Agranulocytosis
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	16 / 395 (4.05%)	12 / 398 (3.02%)
occurrences causally related to treatment / all	17 / 17	13 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	16 / 395 (4.05%)	13 / 398 (3.27%)
occurrences causally related to treatment / all	19 / 19	18 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenocyst
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	10 / 395 (2.53%)	6 / 398 (1.51%)
occurrences causally related to treatment / all	10 / 10	6 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 395 (0.00%)	4 / 398 (1.01%)
occurrences causally related to treatment / all	0 / 0	4 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
White blood cell disorder
subjects affected / exposed	4 / 395 (1.01%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	4 / 4	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
External ear pain
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	0 / 395 (0.00%)	3 / 398 (0.75%)
occurrences causally related to treatment / all	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Uveitis
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal distension
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	2 / 395 (0.51%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	1 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal haemorrhage
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Diarrhoea
subjects affected / exposed	3 / 395 (0.76%)	8 / 398 (2.01%)
occurrences causally related to treatment / all	3 / 3	7 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	6 / 395 (1.52%)	8 / 398 (2.01%)
occurrences causally related to treatment / all	6 / 8	8 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	2 / 395 (0.51%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stomatitis
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis allergic
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Erythema
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Erythema multiforme
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin discolouration
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Pollakiuria
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	3 / 395 (0.76%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Urethral caruncle
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Vomiting
subjects affected / exposed	8 / 395 (2.03%)	8 / 398 (2.01%)
occurrences causally related to treatment / all	8 / 9	8 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	5 / 395 (1.27%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	1 / 5	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Flank pain
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	3 / 395 (0.76%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	2 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporosis
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporotic fracture
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	2 / 395 (0.51%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis infectious
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 395 (0.00%)	3 / 398 (0.75%)
occurrences causally related to treatment / all	0 / 0	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lip infection
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mastitis
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	FEC-Doc	FEC-DocG
Total subjects affected by non serious adverse events
subjects affected / exposed	387 / 395 (97.97%)	387 / 398 (97.24%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	4 / 398 (1.01%)
occurrences all number	5	4
Vascular disorders
Hematoma
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	5 / 398 (1.26%)
occurrences all number	4	5
Phlebitis (including superficial thrombosis)
alternative dictionary used: NCI 3
subjects affected / exposed	13 / 395 (3.29%)	19 / 398 (4.77%)
occurrences all number	14	21
Thrombosis/embolism (vascular access-related)
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	3 / 398 (0.75%)
occurrences all number	5	3
Thrombosis/thrombus/embolism
alternative dictionary used: NCI 3
subjects affected / exposed	12 / 395 (3.04%)	16 / 398 (4.02%)
occurrences all number	12	16
Vascular - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	6 / 398 (1.51%)
occurrences all number	0	7
Surgical and medical procedures
Intra-operative injury - Breast
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	2
Intra-operative injury - Oral
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Intra-operative Injury - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	3 / 398 (0.75%)
occurrences all number	3	3
General disorders and administration site conditions
Constitutional Symptoms - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	23 / 395 (5.82%)	38 / 398 (9.55%)
occurrences all number	26	57
Fatigue (asthenia, lethargy, malaise)
alternative dictionary used: NCI 3
subjects affected / exposed	217 / 395 (54.94%)	230 / 398 (57.79%)
occurrences all number	403	422
Fever
alternative dictionary used: NCI 3
subjects affected / exposed	38 / 395 (9.62%)	51 / 398 (12.81%)
occurrences all number	48	67
Insomnia
alternative dictionary used: NCI 3
subjects affected / exposed	73 / 395 (18.48%)	81 / 398 (20.35%)
occurrences all number	94	105
Odor (patient odor)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Rigors/chills
alternative dictionary used: NCI 3
subjects affected / exposed	6 / 395 (1.52%)	17 / 398 (4.27%)
occurrences all number	7	28
Sweating (diaphoresis)
alternative dictionary used: NCI 3
subjects affected / exposed	27 / 395 (6.84%)	25 / 398 (6.28%)
occurrences all number	31	28
Weight gain
alternative dictionary used: NCI 3
subjects affected / exposed	11 / 395 (2.78%)	10 / 398 (2.51%)
occurrences all number	11	12
Weight loss
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	11 / 398 (2.76%)
occurrences all number	4	11
Pain - Face
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Pain - Joint
alternative dictionary used: NCI 3
subjects affected / exposed	78 / 395 (19.75%)	76 / 398 (19.10%)
occurrences all number	108	109
Pain - Liver
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Pain - Oral cavity
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences all number	1	2
Pain - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	23 / 395 (5.82%)	29 / 398 (7.29%)
occurrences all number	28	37
Pain - Pain NOS
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	9 / 398 (2.26%)
occurrences all number	5	9
Flu-like syndrome
alternative dictionary used: NCI 3
subjects affected / exposed	7 / 395 (1.77%)	7 / 398 (1.76%)
occurrences all number	9	9
Syndromes - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	6 / 395 (1.52%)	6 / 398 (1.51%)
occurrences all number	7	7
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
alternative dictionary used: NCI 3
subjects affected / exposed	17 / 395 (4.30%)	21 / 398 (5.28%)
occurrences all number	22	23
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
alternative dictionary used: NCI 3
subjects affected / exposed	6 / 395 (1.52%)	11 / 398 (2.76%)
occurrences all number	6	11
Allergy/Immunology - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	7 / 395 (1.77%)	8 / 398 (2.01%)
occurrences all number	7	8
Autoimmune reaction
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	0
Reproductive system and breast disorders
Pain - Breast
alternative dictionary used: NCI 3
subjects affected / exposed	6 / 395 (1.52%)	15 / 398 (3.77%)
occurrences all number	6	17
Pain - Ovulatory
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Pain - Uterus
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Breast function/lactation
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Breast nipple/areolar deformity
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Breast volume/hypoplasia
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences all number	0	2
Irregular menses (change from baseline)
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	3 / 398 (0.75%)
occurrences all number	2	4
Libido
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Sexual/Reproductive Function - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	7 / 398 (1.76%)
occurrences all number	5	10
Vaginal discharge (non-infectious)
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Vaginal dryness
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	7 / 398 (1.76%)
occurrences all number	3	8
Vaginal mucositis
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	3 / 398 (0.75%)
occurrences all number	2	3
Vaginitis (not due to infection)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences all number	1	2
Respiratory, thoracic and mediastinal disorders
Pain - Larynx
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences all number	0	2
Pain - Pleura
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences all number	0	2
Pain - Throat/pharynx/larynx
alternative dictionary used: NCI 3
subjects affected / exposed	10 / 395 (2.53%)	15 / 398 (3.77%)
occurrences all number	12	15
Bronchospasm, wheezing
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Cough
alternative dictionary used: NCI 3
subjects affected / exposed	32 / 395 (8.10%)	46 / 398 (11.56%)
occurrences all number	33	53
Dyspnea (shortness of breath)
alternative dictionary used: NCI 3
subjects affected / exposed	62 / 395 (15.70%)	77 / 398 (19.35%)
occurrences all number	78	97
Nasal cavity/paranasal sinus reactions
alternative dictionary used: NCI 3
subjects affected / exposed	10 / 395 (2.53%)	2 / 398 (0.50%)
occurrences all number	10	2
Obstruction/stenosis of airway - Bronchus
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	2
Pleural effusion (non-malignant)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	4 / 398 (1.01%)
occurrences all number	1	4
Pneumonitis/pulmonary infiltrates
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	7 / 398 (1.76%)
occurrences all number	3	7
Pneumothorax
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Pulmonary/Upper Respiratory - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	6 / 395 (1.52%)	12 / 398 (3.02%)
occurrences all number	7	15
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	3 / 398 (0.75%)
occurrences all number	3	3
Investigations
Alkaline phosphatase
alternative dictionary used: NCI 3
subjects affected / exposed	25 / 395 (6.33%)	30 / 398 (7.54%)
occurrences all number	28	46
ALT, SGPT (serum glutamic pyruvic transaminase)
alternative dictionary used: NCI 3
subjects affected / exposed	101 / 395 (25.57%)	173 / 398 (43.47%)
occurrences all number	166	338
AST, SGOT(serum glutamic oxaloacetic transaminase)
alternative dictionary used: NCI 3
subjects affected / exposed	82 / 395 (20.76%)	137 / 398 (34.42%)
occurrences all number	125	226
Bilirubin (hyperbilirubinemia)
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	4 / 398 (1.01%)
occurrences all number	2	8
Calcium, serum-high (hypercalcemia)
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	3 / 398 (0.75%)
occurrences all number	2	3
Calcium, serum-low (hypocalcemia)
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	4 / 398 (1.01%)
occurrences all number	2	5
Cholesterol, serum-high (hypercholesteremia)
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	1 / 398 (0.25%)
occurrences all number	4	1
CPK (creatine phosphokinase)
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Creatinine
alternative dictionary used: NCI 3
subjects affected / exposed	17 / 395 (4.30%)	8 / 398 (2.01%)
occurrences all number	20	12
GGT (gamma-Glutamyl transpeptidase)
alternative dictionary used: NCI 3
subjects affected / exposed	90 / 395 (22.78%)	119 / 398 (29.90%)
occurrences all number	135	210
Glomerular filtration rate
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	3 / 398 (0.75%)
occurrences all number	0	3
Glucose, serum-high (hyperglycemia)
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	6 / 398 (1.51%)
occurrences all number	8	16
Lipase
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Magnesium, serum-low (hypomagnesemia)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Metabolic/Laboratory - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	15 / 395 (3.80%)	27 / 398 (6.78%)
occurrences all number	18	32
Phosphate, serum-low (hypophosphatemia)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Potassium, serum-high (hyperkalemia)
alternative dictionary used: NCI 3
subjects affected / exposed	13 / 395 (3.29%)	12 / 398 (3.02%)
occurrences all number	25	14
Potassium, serum-low (hypokalemia)
alternative dictionary used: NCI 3
subjects affected / exposed	13 / 395 (3.29%)	21 / 398 (5.28%)
occurrences all number	13	25
Proteinuria
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Sodium, serum-high (hypernatremia)
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	2 / 398 (0.50%)
occurrences all number	5	2
Sodium, serum-low (hyponatremia)
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	12 / 398 (3.02%)
occurrences all number	7	15
Triglyceride, serum-high (hypertriglyceridemia)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Uric acid, serum-high (hyperuricemia)
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	8 / 398 (2.01%)
occurrences all number	6	9
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	2 / 398 (0.50%)
occurrences all number	4	2
Palpitations
alternative dictionary used: NCI 3
subjects affected / exposed	10 / 395 (2.53%)	9 / 398 (2.26%)
occurrences all number	8	7
Supraventricular and nodal arrhythmia - Atrial fibrillation
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences all number	3	1
Supraventricular and nodal arrhythmia - Nodal/Junctional
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	2
Supraventricular and nodal arrhythmia - Sinus arrhythmia
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Supraventricular and nodal arrhythmia - Sinus bradycardia
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Supraventricular and nodal arrhythmia - Sinus tachycardia
alternative dictionary used: NCI 3
subjects affected / exposed	9 / 395 (2.28%)	9 / 398 (2.26%)
occurrences all number	9	10
Supraventricular and nodal arrhythmia - Supraventricular tachycardia
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences all number	0	2
Vasovagal episode
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Ventricular arrhythmia - Idioventricular rhythm
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Ventricular arrhythmia - Ventricular flutter
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	2	0
Ventricular arrhythmia - Ventricular tachycardia
alternative dictionary used: NCI 3
subjects affected / exposed	8 / 395 (2.03%)	9 / 398 (2.26%)
occurrences all number	9	9
Cardiac General - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	6 / 395 (1.52%)	11 / 398 (2.76%)
occurrences all number	7	12
Cardiac ischemia/infarction
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Hypertension
alternative dictionary used: NCI 3
subjects affected / exposed	13 / 395 (3.29%)	16 / 398 (4.02%)
occurrences all number	14	19
Hypotension
alternative dictionary used: NCI 3
subjects affected / exposed	11 / 395 (2.78%)	17 / 398 (4.27%)
occurrences all number	15	19
Left ventricular diastolic dysfunction
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	1 / 398 (0.25%)
occurrences all number	3	1
Left ventricular systolic dysfunction
alternative dictionary used: NCI 3
subjects affected / exposed	12 / 395 (3.04%)	3 / 398 (0.75%)
occurrences all number	18	3
Pericardial effusion (non-malignant)
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	2 / 398 (0.50%)
occurrences all number	3	2
Restrictive cardiomyopathy
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Pain - Cardiac/heart
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Pain - Chest wall
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	4 / 398 (1.01%)
occurrences all number	2	4
Pain - Chest/thorax NOS
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	9 / 398 (2.26%)
occurrences all number	4	9
Nervous system disorders
Ataxia (incoordination)
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Cognitive disturbance
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	2 / 398 (0.50%)
occurrences all number	5	2
Confusion
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Dizziness
alternative dictionary used: NCI 3
subjects affected / exposed	43 / 395 (10.89%)	48 / 398 (12.06%)
occurrences all number	64	66
Extrapyramidal/involuntary movement/restlessness
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	3 / 398 (0.75%)
occurrences all number	2	4
Memory impairment
alternative dictionary used: NCI 3
subjects affected / exposed	6 / 395 (1.52%)	9 / 398 (2.26%)
occurrences all number	6	9
Mental status
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Mood alteration - Agitation
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	4 / 398 (1.01%)
occurrences all number	5	4
Mood alteration - Anxiety
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	5 / 398 (1.26%)
occurrences all number	5	6
Mood alteration - Depression
alternative dictionary used: NCI 3
subjects affected / exposed	31 / 395 (7.85%)	35 / 398 (8.79%)
occurrences all number	36	55
Neurology - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	13 / 395 (3.29%)	17 / 398 (4.27%)
occurrences all number	15	21
Neuropathy: cranial - CN I Smell
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	0 / 398 (0.00%)
occurrences all number	2	0
Neuropathy: cranial - CN IX Motor-pharynx; Sensory-ear, pharynx, tongue
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Neuropathy: cranial - CN VII Motor-face; Sensory-taste
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	2 / 398 (0.50%)
occurrences all number	3	2
Neuropathy: motor
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Neuropathy: sensory
alternative dictionary used: NCI 3
subjects affected / exposed	155 / 395 (39.24%)	132 / 398 (33.17%)
occurrences all number	202	175
Personality/behavioral
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	0 / 398 (0.00%)
occurrences all number	3	0
Seizure
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Speech impairment (e.g., dysphasia or aphasia)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Syncope (fainting)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	6 / 398 (1.51%)
occurrences all number	1	7
Tremor
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences all number	1	2
Pain - Head/headache
alternative dictionary used: NCI 3
subjects affected / exposed	53 / 395 (13.42%)	77 / 398 (19.35%)
occurrences all number	75	113
Pain - Neuralgia/peripheral nerve
alternative dictionary used: NCI 3
subjects affected / exposed	12 / 395 (3.04%)	5 / 398 (1.26%)
occurrences all number	14	5
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	41 / 395 (10.38%)	63 / 398 (15.83%)
occurrences all number	105	188
Haptoglobin
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Hemoglobin
alternative dictionary used: NCI 3
subjects affected / exposed	223 / 395 (56.46%)	279 / 398 (70.10%)
occurrences all number	531	683
Leukocytes (total WBC)
alternative dictionary used: NCI 3
subjects affected / exposed	291 / 395 (73.67%)	316 / 398 (79.40%)
occurrences all number	1451	1519
Lymphopenia
alternative dictionary used: NCI 3
subjects affected / exposed	15 / 395 (3.80%)	11 / 398 (2.76%)
occurrences all number	28	20
Neutrophils/granulocytes (ANC/AGC)
alternative dictionary used: NCI 3
subjects affected / exposed	182 / 395 (46.08%)	198 / 398 (49.75%)
occurrences all number	658	643
Platelets
alternative dictionary used: NCI 3
subjects affected / exposed	65 / 395 (16.46%)	88 / 398 (22.11%)
occurrences all number	105	181
Splenic function
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Coagulation - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Fibrinogen
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
PTT (Partial Thromboplastin Time)
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	4 / 398 (1.01%)
occurrences all number	3	4
Thrombotic microangiopathy
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Dermal change lymphedema, phlebolymphedema
alternative dictionary used: NCI 3
subjects affected / exposed	7 / 395 (1.77%)	3 / 398 (0.75%)
occurrences all number	8	3
Edema: head and neck
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	4 / 398 (1.01%)
occurrences all number	4	5
Edema: limb
alternative dictionary used: NCI 3
subjects affected / exposed	77 / 395 (19.49%)	57 / 398 (14.32%)
occurrences all number	103	78
Edema: trunk/genital
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences all number	2	1
Edema: viscera
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences all number	2	3
Lymphatics - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	12 / 395 (3.04%)	18 / 398 (4.52%)
occurrences all number	12	20
Lymphedema-related fibrosis
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	1 / 398 (0.25%)
occurrences all number	4	1
Pain - Lymph node
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	0	0
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences all number	1	3
Otitis, middle ear (non-infectious)
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	1 / 398 (0.25%)
occurrences all number	3	1
Tinnitus
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Pain - External ear
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Eye disorders
Cataract
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	0 / 398 (0.00%)
occurrences all number	3	0
Dry eye syndrome
alternative dictionary used: NCI 3
subjects affected / exposed	23 / 395 (5.82%)	23 / 398 (5.78%)
occurrences all number	28	28
Eyelid dysfunction
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences all number	0	2
Glaucoma
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Keratitis (corneal inflammation/corneal ulceration)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Ocular surface disease
alternative dictionary used: NCI 3
subjects affected / exposed	9 / 395 (2.28%)	11 / 398 (2.76%)
occurrences all number	11	11
Ocular/Visual - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	13 / 395 (3.29%)	15 / 398 (3.77%)
occurrences all number	15	17
Optic disc edema
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	5 / 398 (1.26%)
occurrences all number	5	9
Retinopathy
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Uveitis
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Vision-blurred vision
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	4 / 398 (1.01%)
occurrences all number	4	4
Watery eye (epiphora, tearing)
subjects affected / exposed	41 / 395 (10.38%)	26 / 398 (6.53%)
occurrences all number	44	28
Pain - Eye
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	4 / 398 (1.01%)
occurrences all number	2	4
Gastrointestinal disorders
Anorexia
alternative dictionary used: NCI 3
subjects affected / exposed	35 / 395 (8.86%)	26 / 398 (6.53%)
occurrences all number	51	33
Ascites (non-malignant)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Colitis
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences all number	0	2
Constipation
alternative dictionary used: NCI 3
subjects affected / exposed	118 / 395 (29.87%)	106 / 398 (26.63%)
occurrences all number	181	160
Dehydration
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	2 / 398 (0.50%)
occurrences all number	3	2
Dental: periodontal disease
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences all number	3	1
Dental: teeth
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	3 / 398 (0.75%)
occurrences all number	2	3
Dental: teeth development
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Diarrhea
alternative dictionary used: NCI 3
subjects affected / exposed	121 / 395 (30.63%)	144 / 398 (36.18%)
occurrences all number	170	208
Distension/bloating, abdominal
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	4 / 398 (1.01%)
occurrences all number	1	4
Dry mouth/salivary gland (xerostomia)
alternative dictionary used: NCI 3
subjects affected / exposed	36 / 395 (9.11%)	30 / 398 (7.54%)
occurrences all number	44	35
Dysphagia (difficulty swallowing)
alternative dictionary used: NCI 3
subjects affected / exposed	9 / 395 (2.28%)	18 / 398 (4.52%)
occurrences all number	10	24
Enteritis (inflammation of the small bowel)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Esophagitis
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	7 / 398 (1.76%)
occurrences all number	6	9
Fistula, GI - Anus
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Flatulence
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	9 / 398 (2.26%)
occurrences all number	2	11
Gastritis (including bile reflux gastritis)
alternative dictionary used: NCI 3
subjects affected / exposed	10 / 395 (2.53%)	8 / 398 (2.01%)
occurrences all number	11	8
Gastrointestinal - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	16 / 395 (4.05%)	17 / 398 (4.27%)
occurrences all number	27	26
Heartburn/dyspepsia
alternative dictionary used: NCI 3
subjects affected / exposed	40 / 395 (10.13%)	35 / 398 (8.79%)
occurrences all number	48	45
Hemorrhoids
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	3 / 398 (0.75%)
occurrences all number	4	3
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Incontinence, anal
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Leak (including anastomotic), GI - Biliary tree
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Leak (including anastomotic), GI - Pancreas
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Mucositis/stomatitis (clinical exam) - Anus
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	1 / 398 (0.25%)
occurrences all number	3	1
Mucositis/stomatitis (clinical exam) - Esophagus
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Mucositis/stomatitis (clinical exam) - Larynx
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	4 / 398 (1.01%)
occurrences all number	8	4
Mucositis/stomatitis (clinical exam) - Oral cavity
alternative dictionary used: NCI 3
subjects affected / exposed	128 / 395 (32.41%)	137 / 398 (34.42%)
occurrences all number	182	200
Mucositis/stomatitis (clinical exam) - Pharynx
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences all number	1	3
Mucositis/stomatitis (clinical exam) - Small bowel
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	2	0
Mucositis/stomatitis (clinical exam) - Stomach
alternative dictionary used: NCI 3
subjects affected / exposed	15 / 395 (3.80%)	11 / 398 (2.76%)
occurrences all number	27	12
Mucositis/stomatitis (clinical exam) - Trachea
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Mucositis/stomatitis (functional/symptomatic) - Anus
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Mucositis/stomatitis (functional/symptomatic) - Esophagus
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences all number	1	3
Mucositis/stomatitis (functional/symptomatic) - Larynx
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences all number	1	3
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
alternative dictionary used: NCI 3
subjects affected / exposed	82 / 395 (20.76%)	97 / 398 (24.37%)
occurrences all number	122	128
Mucositis/stomatitis (functional/symptomatic) - Pharynx
alternative dictionary used: NCI 3
subjects affected / exposed	7 / 395 (1.77%)	6 / 398 (1.51%)
occurrences all number	8	6
Mucositis/stomatitis (functional/symptomatic) - Small bowel
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Mucositis/stomatitis (functional/symptomatic) - Stomach
alternative dictionary used: NCI 3
subjects affected / exposed	16 / 395 (4.05%)	16 / 398 (4.02%)
occurrences all number	19	33
Mucositis/stomatitis (functional/symptomatic) - Trachea
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	6 / 398 (1.51%)
occurrences all number	6	7
Nausea
alternative dictionary used: NCI 3
subjects affected / exposed	228 / 395 (57.72%)	249 / 398 (62.56%)
occurrences all number	436	501
Obstruction, GI - Colon
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	4 / 398 (1.01%)
occurrences all number	1	6
Obstruction, GI - Rectum
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences all number	0	2
Perforation, GI - Appendix
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Proctitis
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Salivary gland changes/saliva
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences all number	1	3
Taste alteration (dysgeusia)
alternative dictionary used: NCI 3
subjects affected / exposed	65 / 395 (16.46%)	68 / 398 (17.09%)
occurrences all number	89	91
Vomiting
alternative dictionary used: NCI 3
subjects affected / exposed	101 / 395 (25.57%)	106 / 398 (26.63%)
occurrences all number	136	155
Hemorrhage, GI - Anus
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	0 / 398 (0.00%)
occurrences all number	4	0
Hemorrhage, GI - Oral cavity
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences all number	1	4
Hemorrhage, GI - Rectum
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Hemorrhage, GI - Upper GI NOS
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Hemorrhage, GI - Varices (rectal)
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Hemorrhage, GU - Ovary
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Hemorrhage, GU - Urinary NOS
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Hemorrhage, GU - Uterus
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	2
Hemorrhage, GU - Vagina
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	2	1
Hemorrhage, pulmonary/upper respiratory - Nose
alternative dictionary used: NCI 3
subjects affected / exposed	16 / 395 (4.05%)	18 / 398 (4.52%)
occurrences all number	22	23
Hemorrhage/Bleeding - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences all number	2	3
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Pain - Abdomen NOS
alternative dictionary used: NCI 3
subjects affected / exposed	13 / 395 (3.29%)	19 / 398 (4.77%)
occurrences all number	17	22
Pain - Anus
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Pain - Bladder
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Pain - Dental/teeth/peridontal
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	6 / 398 (1.51%)
occurrences all number	5	6
Pain - Esophagus
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	4 / 398 (1.01%)
occurrences all number	0	4
Pain - Intestine
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	1 / 398 (0.25%)
occurrences all number	4	2
Pain - Stomach
alternative dictionary used: NCI 3
subjects affected / exposed	15 / 395 (3.80%)	33 / 398 (8.29%)
occurrences all number	21	43
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences all number	2	1
Liver dysfunction/failure (clinical)
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences all number	2	1
Pancreatitis
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences all number	2	1
Pain - Gallbladder
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders
Atrophy
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Bruising
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Burn
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	2 / 398 (0.50%)
occurrences all number	3	2
Cheilitis
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	2	1
Dermatology/Skin - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	38 / 395 (9.62%)	43 / 398 (10.80%)
occurrences all number	56	61
Dry skin
alternative dictionary used: NCI 3
subjects affected / exposed	47 / 395 (11.90%)	51 / 398 (12.81%)
occurrences all number	54	67
Flushing
alternative dictionary used: NCI 3
subjects affected / exposed	23 / 395 (5.82%)	24 / 398 (6.03%)
occurrences all number	33	34
Hair loss/alopecia (scalp or body)
alternative dictionary used: NCI 3
subjects affected / exposed	307 / 395 (77.72%)	285 / 398 (71.61%)
occurrences all number	343	317
Hyperpigmentation
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences all number	1	4
Hypopigmentation
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Induration/fibrosis (skin and subcutaneous tissue)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	5 / 398 (1.26%)
occurrences all number	1	5
Injection site reaction/extravasation changes
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	3 / 398 (0.75%)
occurrences all number	0	3
Nail changes
alternative dictionary used: NCI 3
subjects affected / exposed	104 / 395 (26.33%)	84 / 398 (21.11%)
occurrences all number	113	98
Pruritus/itching
alternative dictionary used: NCI 3
subjects affected / exposed	10 / 395 (2.53%)	16 / 398 (4.02%)
occurrences all number	10	22
Rash/desquamation
alternative dictionary used: NCI 3
subjects affected / exposed	14 / 395 (3.54%)	11 / 398 (2.76%)
occurrences all number	14	13
Rash: acne/acneiform
alternative dictionary used: NCI 3
subjects affected / exposed	10 / 395 (2.53%)	17 / 398 (4.27%)
occurrences all number	11	19
Rash: dermatitis associated with radiation - Chemoradiation
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Rash: dermatitis associated with radiation - Radiation
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	5 / 398 (1.26%)
occurrences all number	3	5
Rash: erythema multiforme
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	4 / 398 (1.01%)
occurrences all number	5	4
Rash: hand-foot skin reaction
alternative dictionary used: NCI 3
subjects affected / exposed	57 / 395 (14.43%)	30 / 398 (7.54%)
occurrences all number	65	35
Skin breakdown/decubitus ulcer
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences all number	0	2
Striae
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Telangiectasia
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Ulceration
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	2
Urticaria (hives, welts, wheals)
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences all number	1	3
Wound complication, non-infectious
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	3 / 398 (0.75%)
occurrences all number	6	3
Pain - Skin
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	2 / 398 (0.50%)
occurrences all number	0	2
Renal and urinary disorders
Pain - Kidney
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	3 / 398 (0.75%)
occurrences all number	1	3
Bladder spasms
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Cystitis
alternative dictionary used: NCI 3
subjects affected / exposed	12 / 395 (3.04%)	25 / 398 (6.28%)
occurrences all number	14	33
Incontinence, urinary
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	3 / 398 (0.75%)
occurrences all number	2	3
Renal failure
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	0 / 398 (0.00%)
occurrences all number	2	0
Renal/Genitourinary - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	7 / 398 (1.76%)
occurrences all number	5	8
Urinary frequency/urgency
alternative dictionary used: NCI 3
subjects affected / exposed	11 / 395 (2.78%)	7 / 398 (1.76%)
occurrences all number	11	7
Urinary retention (including neurogenic bladder)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Endocrine disorders
Endocrine - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	3 / 398 (0.75%)
occurrences all number	2	3
Hot flashes/flushes
alternative dictionary used: NCI 3
subjects affected / exposed	67 / 395 (16.96%)	67 / 398 (16.83%)
occurrences all number	98	92
Pancreatic endocrine: glucose intolerance
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Parathyroid function, low (hypoparathyroidism)
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Thyroid function, high (hyperthyroidism, thyrotoxicosis)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	2 / 398 (0.50%)
occurrences all number	1	2
Thyroid function, low (hypothyroidism)
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	2 / 398 (0.50%)
occurrences all number	3	2
Growth and Development - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
alternative dictionary used: NCI 3
subjects affected / exposed	4 / 395 (1.01%)	6 / 398 (1.51%)
occurrences all number	4	13
Bone: spine-scoliosis
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Cervical spine-range of motion
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Extremity-lower (gait/walking)
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Extremity-upper (function)
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	1 / 398 (0.25%)
occurrences all number	2	1
Fracture
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	5 / 398 (1.26%)
occurrences all number	5	5
Joint-function
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	2 / 398 (0.50%)
occurrences all number	3	2
Lumbar spine-range of motion
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Muscle weakness, generalized or specific area (not due to neuropathy)
alternative dictionary used: NCI 3
subjects affected / exposed	7 / 395 (1.77%)	7 / 398 (1.76%)
occurrences all number	9	8
Musculoskeletal/Soft Tissue - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	15 / 395 (3.80%)	17 / 398 (4.27%)
occurrences all number	17	26
Myositis (inflammation/damage of muscle)
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Osteoporosis
alternative dictionary used: NCI 3
subjects affected / exposed	8 / 395 (2.03%)	9 / 398 (2.26%)
occurrences all number	8	9
Seroma
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	1 / 398 (0.25%)
occurrences all number	1	1
Soft tissue necrosis - Thorax
alternative dictionary used: NCI 3
subjects affected / exposed	1 / 395 (0.25%)	0 / 398 (0.00%)
occurrences all number	1	0
Pain - Back
alternative dictionary used: NCI 3
subjects affected / exposed	31 / 395 (7.85%)	32 / 398 (8.04%)
occurrences all number	34	41
Pain - Bone
alternative dictionary used: NCI 3
subjects affected / exposed	141 / 395 (35.70%)	120 / 398 (30.15%)
occurrences all number	204	159
Pain - Extremity-limb
alternative dictionary used: NCI 3
subjects affected / exposed	35 / 395 (8.86%)	31 / 398 (7.79%)
occurrences all number	43	37
Pain - Muscle
alternative dictionary used: NCI 3
subjects affected / exposed	62 / 395 (15.70%)	53 / 398 (13.32%)
occurrences all number	82	73
Pain - Neck
alternative dictionary used: NCI 3
subjects affected / exposed	5 / 395 (1.27%)	4 / 398 (1.01%)
occurrences all number	5	4
Pain - Pelvis
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	3 / 398 (0.75%)
occurrences all number	2	3
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
alternative dictionary used: NCI 3
subjects affected / exposed	2 / 395 (0.51%)	0 / 398 (0.00%)
occurrences all number	2	0
Febrile neutropenia
alternative dictionary used: NCI 3
subjects affected / exposed	22 / 395 (5.57%)	17 / 398 (4.27%)
occurrences all number	22	18
Infection - Other (Specify, __)
alternative dictionary used: NCI 3
subjects affected / exposed	43 / 395 (10.89%)	59 / 398 (14.82%)
occurrences all number	58	77
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
alternative dictionary used: NCI 3
subjects affected / exposed	6 / 395 (1.52%)	6 / 398 (1.51%)
occurrences all number	6	7
Infection with normal ANC or Grade 1 or 2 neutrophils
alternative dictionary used: NCI 3
subjects affected / exposed	32 / 395 (8.10%)	39 / 398 (9.80%)
occurrences all number	44	46
Infection with unknown ANC
alternative dictionary used: NCI 3
subjects affected / exposed	34 / 395 (8.61%)	35 / 398 (8.79%)
occurrences all number	40	46
Viral hepatitis
alternative dictionary used: NCI 3
subjects affected / exposed	0 / 395 (0.00%)	1 / 398 (0.25%)
occurrences all number	0	1
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
alternative dictionary used: NCI 3
subjects affected / exposed	3 / 395 (0.76%)	1 / 398 (0.25%)
occurrences all number	3	1

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Were there any global substantial amendments to the protocol? No

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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Simultaneous Study of Gemcitabine-Docetaxel Combination adjuvant treatment, as well as Biological Targeted Treatment SUCCESS B-Trial

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Clinical trials

Clinical Trial Results: Simultaneous Study of Gemcitabine-Docetaxel Combination adjuvant treatment, as well as Biological Targeted Treatment SUCCESS B-Trial

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Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

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End points

Primary: DFS

Primary: DFS

Adverse events

Adverse events

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Substantial protocol amendments (globally)

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Clinical Trial Results:
Simultaneous Study of Gemcitabine-Docetaxel Combination adjuvant treatment, as well as Biological Targeted Treatment SUCCESS B-Trial