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Clinical Trial Results:
A Phase 3, Multicenter, Open-label, Randomized Study of nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma

Summary
EudraCT number	2013-003398-91
Trial protocol	CZ AT HU ES IT PT BE FI IE DK GB NL
Global end of trial date	30 Jun 2022

Results information
Results version number	v1(current)
This version publication date	29 Jun 2023
First version publication date	29 Jun 2023
Other versions

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

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Trial information

Top of page

Sponsor protocol code

ABI-007-PANC-003

ISRCTN number

-

US NCT number

NCT01964430

WHO universal trial number (UTN)

-

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussée de la Hulpe 185, Brussels, Belgium, 1170

Public contact

EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com

Scientific contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

23 Aug 2022

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

30 Jun 2022

Was the trial ended prematurely?

No

Main objective of the trial

To compare disease-free survival (DFS) between subjects randomized to nabpaclitaxel in combination with gemcitabine and subjects randomized to gemcitabine alone

Protection of trial subjects

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

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

28 Mar 2014

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 31

Country: Number of subjects enrolled

United States: 269

Country: Number of subjects enrolled

Austria: 27

Country: Number of subjects enrolled

Belgium: 13

Country: Number of subjects enrolled

Czechia: 6

Country: Number of subjects enrolled

Denmark: 10

Country: Number of subjects enrolled

Finland: 19

Country: Number of subjects enrolled

France: 37

Country: Number of subjects enrolled

Germany: 85

Country: Number of subjects enrolled

Hungary: 19

Country: Number of subjects enrolled

Ireland: 4

Country: Number of subjects enrolled

Italy: 106

Country: Number of subjects enrolled

Netherlands: 6

Country: Number of subjects enrolled

Portugal: 12

Country: Number of subjects enrolled

Spain: 54

Country: Number of subjects enrolled

United Kingdom: 10

Country: Number of subjects enrolled

Australia: 50

Country: Number of subjects enrolled

Hong Kong: 4

Country: Number of subjects enrolled

Korea, Republic of: 51

Country: Number of subjects enrolled

Singapore: 6

Country: Number of subjects enrolled

Taiwan: 47

Worldwide total number of subjects

866

EEA total number of subjects

398

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

446

From 65 to 84 years

419

85 years and over

1

Subject disposition

Top of page

Recruitment details

The study randomized participants at 160 sites in 21 countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Netherlands, Portugal, Singapore, Republic of Korea, Spain, Taiwan, United Kingdom and the US.

Screening details

Participants were randomized using a stratified randomization with a 1:1 ratio to either nab-paclitaxel followed by gemcitabine, or gemcitabine alone. Stratification factors were tumor resection status (R0 versus R1), nodal status lymph node positive versus lymph node negative, and region [North America, Europe, and Australia versus Asia Pacific]).

Period 1 title

Pre-Treatment (Randomization) Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

nab-Paclitaxel and Gemcitabine

Arm description

Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Arm type

Experimental

Investigational medicinal product name

Gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

1000 mg/m2 as a 30- to 40-minute infusion

Investigational medicinal product name

nab-Paclitaxel

Investigational medicinal product code

Other name

ABRAXANE

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

125 mg/m2 as a 30- to 40-minute infusion

Gemcitabine

Arm description

Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Arm type

Experimental

Investigational medicinal product name

Gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

1000 mg/m2 as a 30- to 40-minute infusion

Number of subjects in period 1	nab-Paclitaxel and Gemcitabine	Gemcitabine
Started	432	434
Completed	429	423
Not completed	3	11
Consent withdrawn by subject	2	9
Adverse event, non-fatal	1	-
Protocol Deviation	-	2

Period 2 title

Treatment Period

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

nab-Paclitaxel and Gemcitabine

Arm description

Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Arm type

Experimental

Investigational medicinal product name

Gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

1000 mg/m2 as a 30- to 40-minute infusion

Investigational medicinal product name

nab-Paclitaxel

Investigational medicinal product code

Other name

ABRAXANE

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

125 mg/m2 as a 30- to 40-minute infusion

Gemcitabine

Arm description

Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Arm type

Experimental

Investigational medicinal product name

Gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

1000 mg/m2 as a 30- to 40-minute infusion

Number of subjects in period 2	nab-Paclitaxel and Gemcitabine	Gemcitabine
Started	429	423
Completed	287	310
Not completed	142	113
Adverse event, serious fatal	1	3
Consent withdrawn by subject	36	27
Physician decision	5	4
Disease Relapse	28	38
Adverse event, non-fatal	71	37
Protocol Deviation	-	1
Other reasons	1	3

Baseline characteristics

Top of page

Reporting group title

nab-Paclitaxel and Gemcitabine

Reporting group description

Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Reporting group title

Gemcitabine

Reporting group description

Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Reporting group values	nab-Paclitaxel and Gemcitabine	Gemcitabine	Total
Number of subjects	432	434	866
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	221	225	446
From 65-84 years	211	208	419
85 years and over	0	1	1
Age Continuous
Units: Years
arithmetic mean (standard deviation)	63.4 ± 9.58	62.9 ± 8.84	-
Sex: Female, Male
Units: Participants
Female	204	181	385
Male	228	253	481
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	11	15	26
Not Hispanic or Latino	400	393	793
Unknown or Not Reported	21	26	47
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	0	1	1
Asian	60	56	116
Black or African American	4	8	12
Native Hawaiian or Other Pacific Islander	0	2	2
White	333	339	672
Other	11	6	17
Not Collected or Reported	24	22	46
Region of Enrollment
Units: Subjects
North America	144	156	300
Europe	203	205	408
Australia	30	20	50
Asia Pacific	55	53	108
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status is used to describe a patient’s level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead
Units: Subjects
0 = Fully Active	252	268	520
1 = Restricted but Ambulatory	180	166	346
2 = Ambulatory but Unable to Work	0	0	0
3 = Limited Self-care	0	0	0
4 = Completely Disabled	0	0	0
Physician Assessment of Peripheral Neuropathy
Physician assessment for grading of peripheral neuropathy in participants receiving chemotherapy according to National Cancer Institute Common Toxicity Criteria (NCICTC): - Grade 1 = Asymptomatic: loss of deep tendon reflexes or paresthesia; - Grade 2 = Moderate symptoms: limiting instrumental Activities of Daily Living (ADLs); - Grade 3 = Severe symptoms: limiting self-care ADL; assistance device indicated; - Grade 4 = Life-threatening consequences: urgent intervention indicated.
Units: Subjects
Grade 0	404	408	812
Grade 1	26	21	47
Grade 2	0	1	1
Grade 3	0	0	0
Grade 4	0	0	0
Missing	2	4	6
TNM Classification
The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The T refers to the size and extent of the main tumor. The main tumor is usually called the primary tumor and the "T" followed by a number shows the size of the tumor. The N refers to the number of nearby lymph nodes that have cancer. The M refers to whether the cancer has metastasized. This means that the cancer has spread from the primary tumor to other parts of the body.
Units: Subjects
T1 = Tumor is 2 cm or smaller	16	13	29
T2 = Tumor is > 2 cm, but not larger than 5 cm	38	37	75
T3 = Tumor is larger than 5 cm	377	384	761
T4 = Tumor is any size, but has spread	1	0	1
Nodal Status
The nodal status refers to the N and includes the number of nearby lymph nodes that are positive or negative for cancer.
Units: Subjects
Lymph Node Positive (LN+)	311	312	623
Lymph Node Negative (LN-)	121	122	243
Resection Status
Resection status was based on investigational site data (pathology reports were collected, but central pathology review and/or standardization was not conducted).
Units: Subjects
R0 (tumor-negative resection margin)	327	334	661
R1 (tumor- positive resection margin)	105	100	205
Time from Surgery to Randomization
Units: Days
median (full range (min-max))	57.0 (23.0 to 90.0)	56.0 (17.0 to 88.0)	-
Body Surface Area (BSA)
Units: m²
arithmetic mean (standard deviation)	1.77 ± 0.226	1.78 ± 0.221	-

End points

Top of page

Reporting group title

nab-Paclitaxel and Gemcitabine

Reporting group description

Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Reporting group title

Gemcitabine

Reporting group description

Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Reporting group title

nab-Paclitaxel and Gemcitabine

Reporting group description

Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Reporting group title

Gemcitabine

Reporting group description

Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Primary: Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee

Top of page

End point title

Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee

End point description

Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date.

End point type

Primary

End point timeframe

Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone

End point values	nab-Paclitaxel and Gemcitabine	Gemcitabine
Number of subjects analysed	432	434
Units: months
median (confidence interval 95%)	19.4 (16.62 to 21.91)	18.8 (13.83 to 20.30)

Disease Free Survival (DFS)

Comparison groups

nab-Paclitaxel and Gemcitabine v Gemcitabine

Number of subjects included in analysis

866

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1824

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.88

Confidence interval

level

95%

sides

2-sided

lower limit

0.729

upper limit

1.063

Secondary: Kaplan Meier Estimate of Overall Survival (OS)

Top of page

End point title

Kaplan Meier Estimate of Overall Survival (OS)

End point description

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cutoff date, whichever was earlier. 99999 = N/A - insufficient number of participants with events.

End point type

Secondary

End point timeframe

From randomization to date of death; median OS follow-up time for censored participants was 77.832 months for nab-Paclitaxel and gemcitabine and 77.799 months for gemcitabine alone

End point values	nab-Paclitaxel and Gemcitabine	Gemcitabine
Number of subjects analysed	432	434
Units: months
median (confidence interval 95%)
25th Quartile	20.7 (19.38 to 22.83)	17.7 (14.78 to 19.91)
50th Quartile	41.8 (35.55 to 47.28)	37.7 (31.11 to 40.51)
75th Quartile	90.2 (83.55 to 99999)	83.0 (61.93 to 99999)

Overall Survival (OS)

Comparison groups

nab-Paclitaxel and Gemcitabine v Gemcitabine

Number of subjects included in analysis

866

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0128

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.81

Confidence interval

level

95%

sides

2-sided

lower limit

0.691

upper limit

0.957

Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAE's)

Top of page

End point title

Number of Participants with Treatment Emergent Adverse Events (TEAE's)

End point description

TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. "Related" TEAE refers to relation to study drug (IP).

End point type

Secondary

End point timeframe

From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018 (up to approximately 37 weeks).

End point values	nab-Paclitaxel and Gemcitabine	Gemcitabine
Number of subjects analysed	429	423
Units: Participants
≥1 TEAE	429	417
≥1 Related TEAE	423	399
≥1 TEAE of Severity Grade 3 or Higher	371	286
≥ 1 Related TEAE of Severity Grade 3 or Higher	332	239
≥1 Serious TEAE	176	96
≥1 Serious Related TEAE	102	55
≥1 TEAE Leading to Withdrawal of IP	117	43
≥1 Related TEAE Leading to Withdrawal of IP	98	35
≥1 TEAE Lead Dose Reduction: nab-Paclitaxel or Gem	276	210
≥1 Related TEAE Dose Reduct: nab-Paclitaxel or Gem	270	205
TEAE Lead Dose Interruption nab-Paclitaxel or Gem	266	158
≥1 Related TEAE Dose Interruption to IP	221	125
TEAE Leading to Death	2	2
>=1 Related TEAE Leading to Death	2	2

No statistical analyses for this end point

Secondary: The Number of Participants with Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)

Top of page

End point title

The Number of Participants with Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)

End point description

The number of participants with grade 3-4 laboratory abnormalities in selected clinically significant parameters. Grades for chemistry parameters were coded using National Cancer Institute Common Terminology Criteria for Adverse Events (Grade 3= severe, Grade 4= life-threatening).

End point type

Secondary

End point timeframe

From day 1 of study drug up to 28 days after the last dose of study drug, or the treatment discontinuation date, whichever was later (up to approximately 37 weeks).

End point values	nab-Paclitaxel and Gemcitabine	Gemcitabine
Number of subjects analysed	421	416
Units: Participants
Alkaline phosphatase	7	3
Alanine aminotransferase	9	3
Aspartate aminotransferase	9	2
Bilirubin	0	1

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Gemcitabine

Reporting group description

Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Reporting group title

nab-Paclitaxel and Gemcitabine

Reporting group description

Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Serious adverse events	Gemcitabine	nab-Paclitaxel and Gemcitabine
Total subjects affected by serious adverse events
subjects affected / exposed	96 / 423 (22.70%)	181 / 429 (42.19%)
number of deaths (all causes)	294	284
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour inflammation
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Hypotension
subjects affected / exposed	3 / 423 (0.71%)	5 / 429 (1.17%)
occurrences causally related to treatment / all	0 / 3	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Capillary leak syndrome
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Circulatory collapse
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	1 / 423 (0.24%)	4 / 429 (0.93%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism
subjects affected / exposed	2 / 423 (0.47%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	2 / 423 (0.47%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Jugular vein thrombosis
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian vein thrombosis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
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
Non-cardiac chest pain
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	1 / 423 (0.24%)	4 / 429 (0.93%)
occurrences causally related to treatment / all	0 / 1	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chills
subjects affected / exposed	2 / 423 (0.47%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	0 / 423 (0.00%)	7 / 429 (1.63%)
occurrences causally related to treatment / all	0 / 0	7 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised oedema
subjects affected / exposed	3 / 423 (0.71%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	3 / 423 (0.71%)	5 / 429 (1.17%)
occurrences causally related to treatment / all	0 / 3	5 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polyserositis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	24 / 423 (5.67%)	29 / 429 (6.76%)
occurrences causally related to treatment / all	0 / 32	16 / 41
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	3 / 423 (0.71%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
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
Cough
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	2 / 423 (0.47%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alveolitis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aspiration
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	5 / 423 (1.18%)	4 / 429 (0.93%)
occurrences causally related to treatment / all	0 / 5	4 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiogenic pulmonary oedema
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	5 / 423 (1.18%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	2 / 423 (0.47%)	4 / 429 (0.93%)
occurrences causally related to treatment / all	0 / 2	4 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	3 / 423 (0.71%)	5 / 429 (1.17%)
occurrences causally related to treatment / all	0 / 3	1 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary oedema
subjects affected / exposed	2 / 423 (0.47%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Confusional state
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device occlusion
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
C-reactive protein increased
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram ST segment elevation
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram T wave inversion
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram repolarisation abnormality
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test increased
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutrophil count decreased
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Post procedural inflammation
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripancreatic fluid collection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural fistula
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	2 / 423 (0.47%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Transfusion-related circulatory overload
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic fracture
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound secretion
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial rupture
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Pericardial effusion
subjects affected / exposed	2 / 423 (0.47%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	2 / 423 (0.47%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 2	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	4 / 423 (0.95%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	2 / 423 (0.47%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	2 / 423 (0.47%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Haemorrhage intracranial
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	1 / 423 (0.24%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 1	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral motor neuropathy
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peroneal nerve palsy
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 423 (0.24%)	4 / 429 (0.93%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
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
Anaemia
subjects affected / exposed	6 / 423 (1.42%)	12 / 429 (2.80%)
occurrences causally related to treatment / all	0 / 6	9 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia of malignant disease
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	3 / 423 (0.71%)	5 / 429 (1.17%)
occurrences causally related to treatment / all	0 / 3	5 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Haemolytic uraemic syndrome
subjects affected / exposed	2 / 423 (0.47%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microangiopathic haemolytic anaemia
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	3 / 423 (0.71%)	16 / 429 (3.73%)
occurrences causally related to treatment / all	0 / 3	15 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 423 (0.24%)	5 / 429 (1.17%)
occurrences causally related to treatment / all	0 / 1	5 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic microangiopathy
subjects affected / exposed	2 / 423 (0.47%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic thrombocytopenic purpura
subjects affected / exposed	2 / 423 (0.47%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Intra-abdominal fluid collection
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal distension
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (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	4 / 423 (0.95%)	7 / 429 (1.63%)
occurrences causally related to treatment / all	0 / 4	3 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Anal incontinence
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic ulcer perforation
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	2 / 423 (0.47%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 423 (0.00%)	4 / 429 (0.93%)
occurrences causally related to treatment / all	0 / 0	3 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 423 (0.00%)	12 / 429 (2.80%)
occurrences causally related to treatment / all	0 / 0	9 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Internal hernia
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 423 (0.00%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Jejunal perforation
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 423 (0.00%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 0	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	3 / 423 (0.71%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal haemorrhage
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic pseudocyst
subjects affected / exposed	1 / 423 (0.24%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	1 / 423 (0.24%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	1 / 423 (0.24%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stomatitis
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 423 (0.00%)	8 / 429 (1.86%)
occurrences causally related to treatment / all	0 / 0	5 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal obstruction
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct obstruction
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stenosis
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	3 / 423 (0.71%)	4 / 429 (0.93%)
occurrences causally related to treatment / all	0 / 3	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis acute
subjects affected / exposed	0 / 423 (0.00%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic failure
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic function abnormal
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertransaminasaemia
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	2 / 423 (0.47%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proteinuria
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (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	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Muscle atrophy
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myositis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal infection
subjects affected / exposed	0 / 423 (0.00%)	4 / 429 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Appendicitis
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis clostridial
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site infection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	5 / 423 (1.18%)	8 / 429 (1.86%)
occurrences causally related to treatment / all	0 / 5	6 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Cholera
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 423 (0.00%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic abscess
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Corona virus infection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	2 / 423 (0.47%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	0 / 423 (0.00%)	4 / 429 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Device related sepsis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis infectious
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile infection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary tract infection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	1 / 423 (0.24%)	9 / 429 (2.10%)
occurrences causally related to treatment / all	0 / 1	9 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious colitis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella bacteraemia
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella infection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	0 / 423 (0.00%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 0	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infection
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic abscess
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periodontitis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	6 / 423 (1.42%)	9 / 429 (2.10%)
occurrences causally related to treatment / all	0 / 6	5 / 10
deaths causally related to treatment / all	0 / 1	0 / 2
Post procedural infection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth infection
subjects affected / exposed	1 / 423 (0.24%)	0 / 429 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	2 / 423 (0.47%)	7 / 429 (1.63%)
occurrences causally related to treatment / all	0 / 2	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection enterococcal
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 423 (0.00%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	5 / 423 (1.18%)	12 / 429 (2.80%)
occurrences causally related to treatment / all	0 / 5	9 / 13
deaths causally related to treatment / all	0 / 1	1 / 1
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Decreased appetite
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	2 / 423 (0.47%)	8 / 429 (1.86%)
occurrences causally related to treatment / all	0 / 2	4 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid retention
subjects affected / exposed	1 / 423 (0.24%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 423 (0.24%)	3 / 429 (0.70%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	2 / 423 (0.47%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoalbuminaemia
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 423 (0.00%)	2 / 429 (0.47%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	0 / 423 (0.00%)	1 / 429 (0.23%)
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: 5%

Non-serious adverse events	Gemcitabine	nab-Paclitaxel and Gemcitabine
Total subjects affected by non serious adverse events
subjects affected / exposed	407 / 423 (96.22%)	426 / 429 (99.30%)
Investigations
Weight decreased
subjects affected / exposed	22 / 423 (5.20%)	52 / 429 (12.12%)
occurrences all number	22	60
Neutrophil count decreased
subjects affected / exposed	32 / 423 (7.57%)	23 / 429 (5.36%)
occurrences all number	69	51
Blood alkaline phosphatase increased
subjects affected / exposed	17 / 423 (4.02%)	23 / 429 (5.36%)
occurrences all number	24	34
Aspartate aminotransferase increased
subjects affected / exposed	21 / 423 (4.96%)	31 / 429 (7.23%)
occurrences all number	31	46
Alanine aminotransferase increased
subjects affected / exposed	33 / 423 (7.80%)	42 / 429 (9.79%)
occurrences all number	51	54
Vascular disorders
Hypotension
subjects affected / exposed	12 / 423 (2.84%)	30 / 429 (6.99%)
occurrences all number	14	37
Hypertension
subjects affected / exposed	49 / 423 (11.58%)	35 / 429 (8.16%)
occurrences all number	70	51
Nervous system disorders
Neuropathy peripheral
subjects affected / exposed	26 / 423 (6.15%)	112 / 429 (26.11%)
occurrences all number	30	128
Headache
subjects affected / exposed	66 / 423 (15.60%)	65 / 429 (15.15%)
occurrences all number	90	91
Dysgeusia
subjects affected / exposed	36 / 423 (8.51%)	86 / 429 (20.05%)
occurrences all number	39	95
Dizziness
subjects affected / exposed	34 / 423 (8.04%)	64 / 429 (14.92%)
occurrences all number	39	77
Paraesthesia
subjects affected / exposed	9 / 423 (2.13%)	39 / 429 (9.09%)
occurrences all number	9	50
Polyneuropathy
subjects affected / exposed	6 / 423 (1.42%)	23 / 429 (5.36%)
occurrences all number	8	27
Peripheral sensory neuropathy
subjects affected / exposed	16 / 423 (3.78%)	144 / 429 (33.57%)
occurrences all number	20	177
General disorders and administration site conditions
Fatigue
subjects affected / exposed	203 / 423 (47.99%)	233 / 429 (54.31%)
occurrences all number	315	350
Asthenia
subjects affected / exposed	49 / 423 (11.58%)	95 / 429 (22.14%)
occurrences all number	116	192
Chills
subjects affected / exposed	23 / 423 (5.44%)	38 / 429 (8.86%)
occurrences all number	27	63
Pyrexia
subjects affected / exposed	115 / 423 (27.19%)	171 / 429 (39.86%)
occurrences all number	194	369
Peripheral swelling
subjects affected / exposed	16 / 423 (3.78%)	22 / 429 (5.13%)
occurrences all number	21	24
Oedema peripheral
subjects affected / exposed	108 / 423 (25.53%)	162 / 429 (37.76%)
occurrences all number	130	207
Influenza like illness
subjects affected / exposed	25 / 423 (5.91%)	27 / 429 (6.29%)
occurrences all number	53	41
Blood and lymphatic system disorders
Thrombocytopenia
subjects affected / exposed	85 / 423 (20.09%)	94 / 429 (21.91%)
occurrences all number	174	212
Neutropenia
subjects affected / exposed	230 / 423 (54.37%)	263 / 429 (61.31%)
occurrences all number	568	638
Leukopenia
subjects affected / exposed	72 / 423 (17.02%)	84 / 429 (19.58%)
occurrences all number	151	201
Anaemia
subjects affected / exposed	142 / 423 (33.57%)	179 / 429 (41.72%)
occurrences all number	214	267
Gastrointestinal disorders
Nausea
subjects affected / exposed	192 / 423 (45.39%)	231 / 429 (53.85%)
occurrences all number	321	431
Dyspepsia
subjects affected / exposed	24 / 423 (5.67%)	21 / 429 (4.90%)
occurrences all number	25	21
Diarrhoea
subjects affected / exposed	125 / 423 (29.55%)	242 / 429 (56.41%)
occurrences all number	183	458
Constipation
subjects affected / exposed	89 / 423 (21.04%)	114 / 429 (26.57%)
occurrences all number	112	150
Abdominal pain upper
subjects affected / exposed	40 / 423 (9.46%)	35 / 429 (8.16%)
occurrences all number	47	38
Abdominal pain
subjects affected / exposed	87 / 423 (20.57%)	119 / 429 (27.74%)
occurrences all number	100	158
Stomatitis
subjects affected / exposed	24 / 423 (5.67%)	81 / 429 (18.88%)
occurrences all number	35	102
Vomiting
subjects affected / exposed	77 / 423 (18.20%)	122 / 429 (28.44%)
occurrences all number	140	208
Flatulence
subjects affected / exposed	27 / 423 (6.38%)	23 / 429 (5.36%)
occurrences all number	31	25
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	18 / 423 (4.26%)	28 / 429 (6.53%)
occurrences all number	18	34
Epistaxis
subjects affected / exposed	13 / 423 (3.07%)	76 / 429 (17.72%)
occurrences all number	14	101
Dyspnoea
subjects affected / exposed	50 / 423 (11.82%)	65 / 429 (15.15%)
occurrences all number	57	71
Cough
subjects affected / exposed	51 / 423 (12.06%)	61 / 429 (14.22%)
occurrences all number	55	73
Skin and subcutaneous tissue disorders
Rash maculo-papular
subjects affected / exposed	20 / 423 (4.73%)	35 / 429 (8.16%)
occurrences all number	27	46
Rash
subjects affected / exposed	20 / 423 (4.73%)	49 / 429 (11.42%)
occurrences all number	23	62
Pruritus
subjects affected / exposed	20 / 423 (4.73%)	37 / 429 (8.62%)
occurrences all number	22	40
Alopecia
subjects affected / exposed	52 / 423 (12.29%)	252 / 429 (58.74%)
occurrences all number	55	264
Psychiatric disorders
Insomnia
subjects affected / exposed	34 / 423 (8.04%)	64 / 429 (14.92%)
occurrences all number	35	72
Anxiety
subjects affected / exposed	38 / 423 (8.98%)	34 / 429 (7.93%)
occurrences all number	38	35
Musculoskeletal and connective tissue disorders
Pain in extremity
subjects affected / exposed	33 / 423 (7.80%)	45 / 429 (10.49%)
occurrences all number	36	56
Myalgia
subjects affected / exposed	29 / 423 (6.86%)	57 / 429 (13.29%)
occurrences all number	42	72
Muscular weakness
subjects affected / exposed	6 / 423 (1.42%)	25 / 429 (5.83%)
occurrences all number	7	33
Bone pain
subjects affected / exposed	15 / 423 (3.55%)	23 / 429 (5.36%)
occurrences all number	16	27
Back pain
subjects affected / exposed	44 / 423 (10.40%)	41 / 429 (9.56%)
occurrences all number	49	55
Arthralgia
subjects affected / exposed	31 / 423 (7.33%)	68 / 429 (15.85%)
occurrences all number	37	89
Infections and infestations
Urinary tract infection
subjects affected / exposed	20 / 423 (4.73%)	29 / 429 (6.76%)
occurrences all number	27	32
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	84 / 423 (19.86%)	143 / 429 (33.33%)
occurrences all number	97	167
Dehydration
subjects affected / exposed	8 / 423 (1.89%)	28 / 429 (6.53%)
occurrences all number	10	39
Hypokalaemia
subjects affected / exposed	23 / 423 (5.44%)	55 / 429 (12.82%)
occurrences all number	34	77
Hyperglycaemia
subjects affected / exposed	28 / 423 (6.62%)	34 / 429 (7.93%)
occurrences all number	39	55

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

23 Jun 2014

Significant changes included: Regional stratification, sample size calculating, assessment of disease recurrence, and eligibility.

03 Dec 2015

Clarification on how to define a subject that has completed 6 cycles of study treatment versus discontinued early from study treatment, what is considered to be new/subsequent anticancer therapy, and dose modifications. Updated treatment administration and schedule section to include flushing requirement.

21 Dec 2016

Removal of the second interim analysis of efficacy and modification of stratification by Region.

12 Sep 2018

Revised the final disease-free survival (DFS) analysis to be earlier than was originally planned (489 events).

03 Sep 2019

Revise the protocol procedures to be performed after achieving the primary endpoint.

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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The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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