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Clinical Trial Results:
A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma

Summary
EudraCT number	2010-022445-20
Trial protocol	CZ HU IE GB DE ES BE AT GR IT PL
Global end of trial date	03 Sep 2021

Results information
Results version number	v1(current)
This version publication date	20 Sep 2022
First version publication date	20 Sep 2022
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

CA204-006

ISRCTN number

-

US NCT number

-

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

04 Mar 2022

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

03 Sep 2021

Was the trial ended prematurely?

No

Main objective of the trial

To compare PFS of lenalidomide/dexamethasone + elotuzumab (E-Ld) versus lenalidomide/dexamethasone (Ld) in subjects with newly diagnosed, untreated multiple myeloma (MM).

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 subjects were followed.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

18 May 2011

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 7

Country: Number of subjects enrolled

Poland: 72

Country: Number of subjects enrolled

Australia: 42

Country: Number of subjects enrolled

Canada: 77

Country: Number of subjects enrolled

Israel: 28

Country: Number of subjects enrolled

United States: 175

Country: Number of subjects enrolled

Czechia: 12

Country: Number of subjects enrolled

Germany: 35

Country: Number of subjects enrolled

Greece: 68

Country: Number of subjects enrolled

Italy: 95

Country: Number of subjects enrolled

Romania: 20

Country: Number of subjects enrolled

Spain: 53

Country: Number of subjects enrolled

Switzerland: 5

Country: Number of subjects enrolled

Belgium: 20

Country: Number of subjects enrolled

Hungary: 16

Country: Number of subjects enrolled

Ireland: 6

Country: Number of subjects enrolled

Russian Federation: 3

Country: Number of subjects enrolled

Turkey: 5

Country: Number of subjects enrolled

United Kingdom: 9

Worldwide total number of subjects

748

EEA total number of subjects

404

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)

40

From 65 to 84 years

677

85 years and over

31

Subject disposition

Top of page

Recruitment details

-

Screening details

- E-Ld cohort: 374 participants were randomized. 371 participants entered the treatment period. - Ld cohort: 374 participants were randomized. 371 participants entered the treatment period.

Period 1 title

Pre-treatment period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

E-Ld cohort

Arm description

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Arm type

Experimental

Investigational medicinal product name

Elotuzumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

20 mL Vial

Investigational medicinal product name

Lenalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

5 mg, 10 mg, 15 mg and 25 mg Capsules

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 mg and 4 mg & various strengths

Investigational medicinal product name

Dexamethosone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravascular use

Dosage and administration details

4 mg/ml, 8 mg/ml & various strengths

Ld cohort

Arm description

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Arm type

Active comparator

Investigational medicinal product name

Lenalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

5 mg, 10 mg, 15 mg and 25 mg Capsules

Investigational medicinal product name

Dexamethosone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravascular use

Dosage and administration details

4 mg/ml, 8 mg/ml & various strengths

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 mg and 4 mg & various strengths

Number of subjects in period 1	E-Ld cohort	Ld cohort
Started	374	374
Completed	371	371
Not completed	3	3
Consent withdrawal	3	-
No longer meeting study criteria	-	1
Participant request to discontinue	-	1
Adverse event unrelated to study drug	-	1

Period 2 title

Treatment period

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

E-Ld cohort

Arm description

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Arm type

Experimental

Investigational medicinal product name

Elotuzumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravascular use

Dosage and administration details

400 mg/vial

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 mg and 4 mg & various strengths

Investigational medicinal product name

Dexamethosone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravascular use

Dosage and administration details

4 mg/ml, 8 mg/ml & various strengths

Investigational medicinal product name

Lenalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

5 mg, 10 mg, 15 mg and 25 mg

Ld cohort

Arm description

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Arm type

Active comparator

Investigational medicinal product name

Lenalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

5 mg, 10 mg, 15 mg and 25 mg

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 mg and 4 mg & various strengths

Investigational medicinal product name

Dexamethosone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravascular use

Dosage and administration details

4 mg/ml, 8 mg/ml & various strengths

Number of subjects in period 2	E-Ld cohort	Ld cohort
Started	371	371
Completed	0	0
Not completed	371	371
Adverse event, serious fatal	7	6
No longer meet study criteria	1	1
Disease progression	117	145
Consent withdrawal	10	7
Study drug toxicity	52	64
Participant request to discontinue	30	22
Maximum clinical benefit	1	1
Adverse event unrelated to study drug	110	73
Other reasons	30	30
Poor/Non-compliance	3	4
Administrative reasons by Sponsor	8	16
Lost to follow-up	2	2

Baseline characteristics

Top of page

Reporting group title

E-Ld cohort

Reporting group description

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Reporting group title

Ld cohort

Reporting group description

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Reporting group values	E-Ld cohort	Ld cohort	Total
Number of subjects	374	374	748
Age categorical
Units: Subjects
Adults (18-64 years)	20	20	40
From 65-84 years	341	336	677
85 years and over	13	18	31
Age Continuous
Units: Years
arithmetic mean (standard deviation)	72.9 ( 6.58 )	73.1 ( 6.70 )	-
Sex: Female, Male
Units: Participants
Female	163	173	336
Male	211	201	412
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0
Asian	1	4	5
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	13	16	29
White	360	351	711
More than one race	0	0	0
Unknown or Not Reported	0	2	2
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	9	8	17
Not Hispanic or Latino	70	87	157
Unknown or Not Reported	295	279	574

End points

Top of page

Reporting group title

E-Ld cohort

Reporting group description

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Reporting group title

Ld cohort

Reporting group description

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Reporting group title

E-Ld cohort

Reporting group description

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Reporting group title

Ld cohort

Reporting group description

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Primary: Progression-Free Survival (PFS)

Top of page

End point title

Progression-Free Survival (PFS)

End point description

PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: - Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. - Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. - Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. - Participants without any post-baseline tumor assessments were censored on the date of randomization

End point type

Primary

End point timeframe

From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)

End point values	E-Ld cohort	Ld cohort
Number of subjects analysed	374	374
Units: Months
median (confidence interval 95%)	31.38 (26.18 to 36.80)	29.47 (23.49 to 34.30)

Statistical Analaysis for PFS

Comparison groups

E-Ld cohort v Ld cohort

Number of subjects included in analysis

748

Analysis specification

Pre-specified

Analysis type

P-value

= 0.4358

Method

Stratified Log Rank

Confidence interval

Statistical Anlaysis of PFS

Comparison groups

E-Ld cohort v Ld cohort

Number of subjects included in analysis

748

Analysis specification

Pre-specified

Analysis type

Method

Parameter type

Hazard ratio (HR)

Point estimate

0.93

Confidence interval

level

95.71%

sides

2-sided

lower limit

0.77

upper limit

1.12

Secondary: Objective Response Rate (ORR)

Top of page

End point title

Objective Response Rate (ORR)

End point description

ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Indipendent Review Committee (IRC) assessment, as per EBMT criteria.

End point type

Secondary

End point timeframe

From randomization to primary completion date (approximately 8 years)

End point values	E-Ld cohort	Ld cohort
Number of subjects analysed	374	374
Units: Percent of Participants
number (confidence interval 95%)	82.9 (78.7 to 86.6)	79.4 (75.0 to 83.4)

Statistical Analysis for ORR

Comparison groups

E-Ld cohort v Ld cohort

Number of subjects included in analysis

748

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2232

Method

CMH ESTIMATE OF COMMON ODDS RATIO

Parameter type

CMH ESTIMATE OF COMMON ODDS RATIO

Point estimate

1.26

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.82

Secondary: Overall Survival (OS)

Top of page

End point title

Overall Survival (OS)

End point description

Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact (‘last known date alive”).

End point type

Secondary

End point timeframe

From randomization to the date of death (up to 8 years)

End point values	E-Ld cohort	Ld cohort
Number of subjects analysed	374	374
Units: Months
median (confidence interval 95%)	60.42 (52.76 to 67.35)	57.56 (48.95 to 66.56)

Statistical Analysis for OS

Comparison groups

E-Ld cohort v Ld cohort

Number of subjects included in analysis

748

Analysis specification

Pre-specified

Analysis type

P-value

= 0.8932

Method

Stratified log rank test

Parameter type

Hazard ratio (HR)

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.82

upper limit

1.19

Secondary: Mean Change from Baseline of Pain Severity Score and Pain Interference Score

Top of page

End point title

Mean Change from Baseline of Pain Severity Score and Pain Interference Score

End point description

Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).

End point type

Secondary

End point timeframe

From Baseline to End of Treatment (approximately 8 years)

End point values	E-Ld cohort	Ld cohort
Number of subjects analysed	374	374
Units: Rating score
arithmetic mean (standard deviation)
Pain Severity	0.02 ( 2.645 )	-0.25 ( 2.721 )
Pain Interference	0.33 ( 3.077 )	-0.18 ( 3.082 )

No statistical analyses for this end point

Secondary: Progression Free Survival (PFS) Rate at Specific Time-points

Top of page

End point title

Progression Free Survival (PFS) Rate at Specific Time-points

End point description

PFS rate is defined as the proportion of participants experiencing PFS at the defined time-points.

End point type

Secondary

End point timeframe

From randomization to the specified time-point (up to 5 years)

End point values	E-Ld cohort	Ld cohort
Number of subjects analysed	374	374
Units: Percent of participants
number (confidence interval 95%)
1 year	0.77 (0.72 to 0.81)	0.76 (0.71 to 0.80)
2 year	0.59 (0.53 to 0.64)	0.55 (0.49 to 0.60)
3 year	0.46 (0.40 to 0.51)	0.41 (0.35 to 0.46)
4 year	0.36 (0.31 to 0.41)	0.33 (0.28 to 0.38)
5 year	0.26 (0.21 to 0.32)	0.25 (0.20 to 0.30)

Statistical Analysis for PFS

Statistical analysis description

Statistical Analysis for PFS at specific time points

Comparison groups

E-Ld cohort v Ld cohort

Number of subjects included in analysis

748

Analysis specification

Pre-specified

Analysis type

P-value

= 0.4358

Method

Hazard Ratio

Parameter type

Hazard ratio (HR)

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.78

upper limit

1.12

Adverse events

Top of page

Timeframe for reporting adverse events

From first dose to 60 days after last dose (up to 93.3 months)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

MedDRA24.1

Reporting group title

Ld Cohort

Reporting group description

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Reporting group title

E-Ld Cohort

Reporting group description

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Serious adverse events	Ld Cohort	E-Ld Cohort
Total subjects affected by serious adverse events
subjects affected / exposed	279 / 371 (75.20%)	293 / 371 (78.98%)
number of deaths (all causes)	232	240
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma metastatic
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Adenocarcinoma pancreas
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Angiosarcoma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Atypical fibroxanthoma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	10 / 371 (2.70%)	10 / 371 (2.70%)
occurrences causally related to treatment / all	6 / 11	6 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Basosquamous carcinoma
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bowen's disease
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Colon cancer
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer metastatic
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Hepatic cancer
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Hepatocellular carcinoma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal proliferative breast lesion
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Keratoacanthoma
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lip squamous cell carcinoma
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal squamous cell carcinoma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Malignant melanoma in situ
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm progression
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal cavity cancer
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papilloma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell leukaemia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	3 / 371 (0.81%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 3
Plasmacytoma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	0 / 371 (0.00%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	0 / 0	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectosigmoid cancer
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Refractory anaemia with ringed sideroblasts
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sebaceous carcinoma
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spindle cell sarcoma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	7 / 371 (1.89%)	13 / 371 (3.50%)
occurrences causally related to treatment / all	5 / 9	6 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	7 / 371 (1.89%)	9 / 371 (2.43%)
occurrences causally related to treatment / all	3 / 14	4 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of head and neck
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Squamous cell carcinoma of the oral cavity
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Aortic aneurysm
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Arteriosclerosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (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	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	10 / 371 (2.70%)	9 / 371 (2.43%)
occurrences causally related to treatment / all	8 / 10	7 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism
subjects affected / exposed	0 / 371 (0.00%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Embolism venous
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	2 / 371 (0.54%)	7 / 371 (1.89%)
occurrences causally related to treatment / all	0 / 2	1 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
Hypovolaemic shock
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Malignant hypertension
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Superficial vein thrombosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Adverse drug reaction
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	6 / 371 (1.62%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	1 / 6	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	4 / 371 (1.08%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Complication associated with device
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	3 / 371 (0.81%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 2
Disease progression
subjects affected / exposed	5 / 371 (1.35%)	8 / 371 (2.16%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 5	0 / 8
Fat necrosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	5 / 371 (1.35%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	1 / 5	1 / 3
deaths causally related to treatment / all	0 / 2	0 / 1
Fatigue
subjects affected / exposed	2 / 371 (0.54%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammation
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
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 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Non-cardiac chest pain
subjects affected / exposed	3 / 371 (0.81%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	4 / 371 (1.08%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	2 / 4	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	3 / 371 (0.81%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Performance status decreased
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	7 / 371 (1.89%)	19 / 371 (5.12%)
occurrences causally related to treatment / all	1 / 7	11 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Sudden death
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
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
Endometrial hyperplasia
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine prolapse
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
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
Acute pulmonary oedema
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Acute respiratory failure
subjects affected / exposed	0 / 371 (0.00%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Bronchiectasis
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 14	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchopneumopathy
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Bronchospasm
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	7 / 371 (1.89%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	3 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	8 / 371 (2.16%)	13 / 371 (3.50%)
occurrences causally related to treatment / all	1 / 8	3 / 15
deaths causally related to treatment / all	0 / 1	0 / 0
Epistaxis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	3 / 371 (0.81%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 3	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	3 / 371 (0.81%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	1 / 3	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
Pleuritic pain
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	4 / 371 (1.08%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary congestion
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	15 / 371 (4.04%)	12 / 371 (3.23%)
occurrences causally related to treatment / all	14 / 15	9 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	4 / 371 (1.08%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	1 / 4	2 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Respiratory depression
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Respiratory disorder
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Respiratory failure
subjects affected / exposed	3 / 371 (0.81%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 1
Restrictive pulmonary disease
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus disorder
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord disorder
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Anxiety
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Confusional state
subjects affected / exposed	5 / 371 (1.35%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Delusional disorder, unspecified type
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device dislocation
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	4 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Aspartate aminotransferase increased
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial test positive
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	2 / 371 (0.54%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	1 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
C-reactive protein increased
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza A virus test positive
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza B virus test positive
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus test positive
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respirovirus test positive
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral test positive
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accidental overdose
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Combined tibia-fibula fracture
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Comminuted fracture
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	3 / 371 (0.81%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	8 / 371 (2.16%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture
subjects affected / exposed	0 / 371 (0.00%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	4 / 371 (1.08%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infusion related reaction
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Medication error
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Overdose
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Rib fracture
subjects affected / exposed	4 / 371 (1.08%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Shunt malfunction
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	4 / 371 (1.08%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	3 / 371 (0.81%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stress fracture
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Thoracic vertebral fracture
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic fracture
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Corneal dystrophy
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	2 / 371 (0.54%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	1 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	0 / 371 (0.00%)	7 / 371 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve calcification
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Arrhythmia
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 1	1 / 1
Atrial fibrillation
subjects affected / exposed	12 / 371 (3.23%)	22 / 371 (5.93%)
occurrences causally related to treatment / all	4 / 14	3 / 26
deaths causally related to treatment / all	0 / 0	1 / 2
Atrial flutter
subjects affected / exposed	3 / 371 (0.81%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	1 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	6 / 371 (1.62%)	7 / 371 (1.89%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 6	0 / 6
Cardiac failure
subjects affected / exposed	7 / 371 (1.89%)	13 / 371 (3.50%)
occurrences causally related to treatment / all	0 / 7	1 / 16
deaths causally related to treatment / all	0 / 2	0 / 4
Cardiac failure acute
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac failure chronic
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	2 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	4 / 371 (1.08%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	2 / 4	2 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiac septal hypertrophy
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac ventricular thrombosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiogenic shock
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardio-respiratory arrest
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Cardiomyopathy
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiovascular disorder
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Congestive cardiomyopathy
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Left ventricular dysfunction
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Myocardial infarction
subjects affected / exposed	5 / 371 (1.35%)	6 / 371 (1.62%)
occurrences causally related to treatment / all	1 / 5	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 2
Pericarditis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prinzmetal angina
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus arrest
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	1 / 371 (0.27%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Systolic dysfunction
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	0 / 371 (0.00%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Torsade de pointes
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Ataxia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar haemorrhage
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	3 / 371 (0.81%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Cerebral infarction
subjects affected / exposed	2 / 371 (0.54%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	2 / 371 (0.54%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 2	2 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Cerebrovascular accident
subjects affected / exposed	7 / 371 (1.89%)	8 / 371 (2.16%)
occurrences causally related to treatment / all	5 / 8	3 / 8
deaths causally related to treatment / all	0 / 1	0 / 1
Coma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depressed level of consciousness
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness postural
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic cerebral infarction
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (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 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial haematoma
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cerebral infarction
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	1 / 371 (0.27%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 1	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Lethargy
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Memory impairment
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (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 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normal pressure hydrocephalus
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Somnolence
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Syncope
subjects affected / exposed	5 / 371 (1.35%)	7 / 371 (1.89%)
occurrences causally related to treatment / all	0 / 5	2 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Transient aphasia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	4 / 371 (1.08%)	6 / 371 (1.62%)
occurrences causally related to treatment / all	0 / 4	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Agranulocytosis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	12 / 371 (3.23%)	12 / 371 (3.23%)
occurrences causally related to treatment / all	4 / 17	5 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	3 / 371 (0.81%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	1 / 3	3 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Haemolysis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemolytic anaemia
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	0 / 371 (0.00%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Plasmacytosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Thrombocytopenia
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Sudden hearing loss
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Blindness transient
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	9 / 371 (2.43%)	10 / 371 (2.70%)
occurrences causally related to treatment / all	8 / 13	6 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract cortical
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epiretinal membrane
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Optic ischaemic neuropathy
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal haemorrhage
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anorectal varices haemorrhage
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	2 / 371 (0.54%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	1 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic hernia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	10 / 371 (2.70%)	9 / 371 (2.43%)
occurrences causally related to treatment / all	3 / 11	2 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral hernia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 371 (0.00%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 0	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Incarcerated inguinal hernia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated umbilical hernia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	2 / 371 (0.54%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia strangulated
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal infarction
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	2 / 371 (0.54%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	3 / 371 (0.81%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	2 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Odynophagia
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oroantral fistula
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	3 / 371 (0.81%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumatosis intestinalis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Varices oesophageal
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 371 (0.27%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary obstruction
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder rupture
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocholecystis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Actinic keratosis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angioedema
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cold sweat
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cutaneous vasculitis
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis bullous
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis exfoliative generalised
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erythema
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Exfoliative rash
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Purpura
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rash
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rash maculo-papular
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stasis dermatitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous emphysema
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stevens-Johnson syndrome
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
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	20 / 371 (5.39%)	20 / 371 (5.39%)
occurrences causally related to treatment / all	4 / 21	4 / 20
deaths causally related to treatment / all	0 / 1	0 / 2
Calculus urinary
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myeloma cast nephropathy
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Haematuria
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	7 / 371 (1.89%)	10 / 371 (2.70%)
occurrences causally related to treatment / all	2 / 7	5 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	2 / 371 (0.54%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	3 / 371 (0.81%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal injury
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract disorder
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 371 (0.54%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis reactive
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	9 / 371 (2.43%)	11 / 371 (2.96%)
occurrences causally related to treatment / all	0 / 11	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Bone pain
subjects affected / exposed	4 / 371 (1.08%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chondrocalcinosis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chondrocalcinosis pyrophosphate
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Flank pain
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle contracture
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint hyperextension
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal disorder
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
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 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	0 / 371 (0.00%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis of jaw
subjects affected / exposed	2 / 371 (0.54%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	1 / 371 (0.27%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (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	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Bacteraemia
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial prostatitis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary sepsis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	6 / 371 (1.62%)	18 / 371 (4.85%)
occurrences causally related to treatment / all	1 / 6	6 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis infective
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	8 / 371 (2.16%)	9 / 371 (2.43%)
occurrences causally related to treatment / all	1 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis orbital
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Central nervous system infection
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridial sepsis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium colitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Clostridium difficile colitis
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dacryocystitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	3 / 371 (0.81%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	0 / 3	4 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia infection
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile infection
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	2 / 371 (0.54%)	8 / 371 (2.16%)
occurrences causally related to treatment / all	0 / 2	2 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis clostridial
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
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	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
H1N1 influenza
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis E
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
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	2 / 371 (0.54%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster disseminated
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected cyst
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
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 / 371 (0.27%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 1	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Influenza
subjects affected / exposed	6 / 371 (1.62%)	7 / 371 (1.89%)
occurrences causally related to treatment / all	1 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine infection
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leishmaniasis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis listeria
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lower respiratory tract infection
subjects affected / exposed	8 / 371 (2.16%)	9 / 371 (2.43%)
occurrences causally related to treatment / all	4 / 8	1 / 10
deaths causally related to treatment / all	0 / 1	0 / 0
Metapneumovirus bronchiolitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metapneumovirus infection
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pharyngitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plague
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural infection
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumococcal sepsis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonia
subjects affected / exposed	48 / 371 (12.94%)	60 / 371 (16.17%)
occurrences causally related to treatment / all	11 / 58	21 / 80
deaths causally related to treatment / all	1 / 5	2 / 10
Pneumonia aspiration
subjects affected / exposed	0 / 371 (0.00%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 2
Pneumonia bacterial
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia cytomegaloviral
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia fungal
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Pneumonia streptococcal
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Progressive multifocal leukoencephalopathy
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Pseudomembranous colitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyoderma
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	3 / 371 (0.81%)	8 / 371 (2.16%)
occurrences causally related to treatment / all	2 / 5	2 / 9
deaths causally related to treatment / all	0 / 0	0 / 1
Sepsis
subjects affected / exposed	6 / 371 (1.62%)	15 / 371 (4.04%)
occurrences causally related to treatment / all	3 / 6	1 / 15
deaths causally related to treatment / all	0 / 1	0 / 5
Septic shock
subjects affected / exposed	6 / 371 (1.62%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	2 / 6	0 / 4
deaths causally related to treatment / all	2 / 5	0 / 4
Staphylococcal infection
subjects affected / exposed	0 / 371 (0.00%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	4 / 371 (1.08%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	1 / 4	1 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Urinary tract infection
subjects affected / exposed	11 / 371 (2.96%)	15 / 371 (4.04%)
occurrences causally related to treatment / all	3 / 13	2 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (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 enterococcal
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	5 / 371 (1.35%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	2 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Varicella zoster virus infection
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular device infection
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Whipple's disease
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Wound infection staphylococcal
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Alcohol intolerance
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
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 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	5 / 371 (1.35%)	7 / 371 (1.89%)
occurrences causally related to treatment / all	2 / 5	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic complication
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic metabolic decompensation
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	2 / 371 (0.54%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	1 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	5 / 371 (1.35%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	2 / 371 (0.54%)	3 / 371 (0.81%)
occurrences causally related to treatment / all	2 / 2	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoalbuminaemia
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	4 / 371 (1.08%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	1 / 371 (0.27%)	5 / 371 (1.35%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	1 / 371 (0.27%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	0 / 371 (0.00%)	4 / 371 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	1 / 371 (0.27%)	2 / 371 (0.54%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypophosphataemia
subjects affected / exposed	0 / 371 (0.00%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	1 / 371 (0.27%)	0 / 371 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour lysis syndrome
subjects affected / exposed	1 / 371 (0.27%)	1 / 371 (0.27%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Ld Cohort	E-Ld Cohort
Total subjects affected by non serious adverse events
subjects affected / exposed	365 / 371 (98.38%)	364 / 371 (98.11%)
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	26 / 371 (7.01%)	20 / 371 (5.39%)
occurrences all number	30	20
Flushing
subjects affected / exposed	17 / 371 (4.58%)	19 / 371 (5.12%)
occurrences all number	18	22
Hypertension
subjects affected / exposed	44 / 371 (11.86%)	54 / 371 (14.56%)
occurrences all number	60	100
Hypotension
subjects affected / exposed	44 / 371 (11.86%)	63 / 371 (16.98%)
occurrences all number	51	86
General disorders and administration site conditions
Asthenia
subjects affected / exposed	73 / 371 (19.68%)	88 / 371 (23.72%)
occurrences all number	108	137
Chest pain
subjects affected / exposed	32 / 371 (8.63%)	24 / 371 (6.47%)
occurrences all number	39	30
Chills
subjects affected / exposed	9 / 371 (2.43%)	35 / 371 (9.43%)
occurrences all number	12	44
Fatigue
subjects affected / exposed	188 / 371 (50.67%)	183 / 371 (49.33%)
occurrences all number	279	288
Influenza like illness
subjects affected / exposed	28 / 371 (7.55%)	40 / 371 (10.78%)
occurrences all number	54	61
Mucosal inflammation
subjects affected / exposed	8 / 371 (2.16%)	21 / 371 (5.66%)
occurrences all number	8	28
Non-cardiac chest pain
subjects affected / exposed	19 / 371 (5.12%)	20 / 371 (5.39%)
occurrences all number	22	23
Oedema
subjects affected / exposed	19 / 371 (5.12%)	17 / 371 (4.58%)
occurrences all number	21	17
Oedema peripheral
subjects affected / exposed	182 / 371 (49.06%)	163 / 371 (43.94%)
occurrences all number	314	259
Pain
subjects affected / exposed	19 / 371 (5.12%)	24 / 371 (6.47%)
occurrences all number	36	27
Peripheral swelling
subjects affected / exposed	24 / 371 (6.47%)	24 / 371 (6.47%)
occurrences all number	30	25
Pyrexia
subjects affected / exposed	77 / 371 (20.75%)	111 / 371 (29.92%)
occurrences all number	167	211
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	106 / 371 (28.57%)	120 / 371 (32.35%)
occurrences all number	168	191
Dysphonia
subjects affected / exposed	27 / 371 (7.28%)	45 / 371 (12.13%)
occurrences all number	30	49
Dyspnoea
subjects affected / exposed	93 / 371 (25.07%)	87 / 371 (23.45%)
occurrences all number	122	118
Dyspnoea exertional
subjects affected / exposed	18 / 371 (4.85%)	24 / 371 (6.47%)
occurrences all number	20	30
Epistaxis
subjects affected / exposed	18 / 371 (4.85%)	27 / 371 (7.28%)
occurrences all number	26	33
Oropharyngeal pain
subjects affected / exposed	26 / 371 (7.01%)	26 / 371 (7.01%)
occurrences all number	35	30
Productive cough
subjects affected / exposed	20 / 371 (5.39%)	33 / 371 (8.89%)
occurrences all number	24	43
Psychiatric disorders
Agitation
subjects affected / exposed	17 / 371 (4.58%)	21 / 371 (5.66%)
occurrences all number	21	23
Anxiety
subjects affected / exposed	28 / 371 (7.55%)	44 / 371 (11.86%)
occurrences all number	33	50
Confusional state
subjects affected / exposed	32 / 371 (8.63%)	37 / 371 (9.97%)
occurrences all number	35	43
Depression
subjects affected / exposed	31 / 371 (8.36%)	42 / 371 (11.32%)
occurrences all number	35	45
Insomnia
subjects affected / exposed	96 / 371 (25.88%)	98 / 371 (26.42%)
occurrences all number	112	129
Mood altered
subjects affected / exposed	17 / 371 (4.58%)	25 / 371 (6.74%)
occurrences all number	33	26
Investigations
Alanine aminotransferase increased
subjects affected / exposed	27 / 371 (7.28%)	18 / 371 (4.85%)
occurrences all number	38	24
Aspartate aminotransferase increased
subjects affected / exposed	21 / 371 (5.66%)	17 / 371 (4.58%)
occurrences all number	27	25
Blood creatinine increased
subjects affected / exposed	72 / 371 (19.41%)	56 / 371 (15.09%)
occurrences all number	111	85
Neutrophil count decreased
subjects affected / exposed	28 / 371 (7.55%)	11 / 371 (2.96%)
occurrences all number	55	27
Glomerular filtration rate decreased
subjects affected / exposed	17 / 371 (4.58%)	20 / 371 (5.39%)
occurrences all number	35	37
Platelet count decreased
subjects affected / exposed	20 / 371 (5.39%)	12 / 371 (3.23%)
occurrences all number	58	17
Weight decreased
subjects affected / exposed	66 / 371 (17.79%)	79 / 371 (21.29%)
occurrences all number	78	93
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	53 / 371 (14.29%)	47 / 371 (12.67%)
occurrences all number	72	60
Fall
subjects affected / exposed	32 / 371 (8.63%)	33 / 371 (8.89%)
occurrences all number	49	46
Skin abrasion
subjects affected / exposed	13 / 371 (3.50%)	24 / 371 (6.47%)
occurrences all number	15	29
Skin laceration
subjects affected / exposed	23 / 371 (6.20%)	19 / 371 (5.12%)
occurrences all number	31	26
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	25 / 371 (6.74%)	28 / 371 (7.55%)
occurrences all number	29	35
Nervous system disorders
Dizziness
subjects affected / exposed	68 / 371 (18.33%)	84 / 371 (22.64%)
occurrences all number	102	124
Dysgeusia
subjects affected / exposed	13 / 371 (3.50%)	26 / 371 (7.01%)
occurrences all number	15	29
Headache
subjects affected / exposed	50 / 371 (13.48%)	61 / 371 (16.44%)
occurrences all number	73	85
Hypoaesthesia
subjects affected / exposed	25 / 371 (6.74%)	24 / 371 (6.47%)
occurrences all number	28	28
Memory impairment
subjects affected / exposed	15 / 371 (4.04%)	27 / 371 (7.28%)
occurrences all number	16	28
Neuropathy peripheral
subjects affected / exposed	48 / 371 (12.94%)	41 / 371 (11.05%)
occurrences all number	54	48
Paraesthesia
subjects affected / exposed	45 / 371 (12.13%)	40 / 371 (10.78%)
occurrences all number	55	65
Peripheral sensory neuropathy
subjects affected / exposed	59 / 371 (15.90%)	57 / 371 (15.36%)
occurrences all number	71	70
Syncope
subjects affected / exposed	20 / 371 (5.39%)	18 / 371 (4.85%)
occurrences all number	23	22
Taste disorder
subjects affected / exposed	27 / 371 (7.28%)	24 / 371 (6.47%)
occurrences all number	27	24
Tremor
subjects affected / exposed	55 / 371 (14.82%)	61 / 371 (16.44%)
occurrences all number	69	72
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	160 / 371 (43.13%)	153 / 371 (41.24%)
occurrences all number	325	338
Leukopenia
subjects affected / exposed	37 / 371 (9.97%)	23 / 371 (6.20%)
occurrences all number	141	83
Neutropenia
subjects affected / exposed	117 / 371 (31.54%)	93 / 371 (25.07%)
occurrences all number	397	286
Thrombocytopenia
subjects affected / exposed	69 / 371 (18.60%)	66 / 371 (17.79%)
occurrences all number	153	178
Eye disorders
Cataract
subjects affected / exposed	56 / 371 (15.09%)	61 / 371 (16.44%)
occurrences all number	64	70
Vision blurred
subjects affected / exposed	28 / 371 (7.55%)	28 / 371 (7.55%)
occurrences all number	30	29
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	51 / 371 (13.75%)	50 / 371 (13.48%)
occurrences all number	66	76
Abdominal pain upper
subjects affected / exposed	29 / 371 (7.82%)	33 / 371 (8.89%)
occurrences all number	37	40
Constipation
subjects affected / exposed	144 / 371 (38.81%)	142 / 371 (38.27%)
occurrences all number	215	230
Diarrhoea
subjects affected / exposed	180 / 371 (48.52%)	192 / 371 (51.75%)
occurrences all number	399	476
Dry mouth
subjects affected / exposed	26 / 371 (7.01%)	28 / 371 (7.55%)
occurrences all number	31	30
Dyspepsia
subjects affected / exposed	32 / 371 (8.63%)	43 / 371 (11.59%)
occurrences all number	34	58
Haemorrhoids
subjects affected / exposed	19 / 371 (5.12%)	10 / 371 (2.70%)
occurrences all number	21	10
Nausea
subjects affected / exposed	108 / 371 (29.11%)	117 / 371 (31.54%)
occurrences all number	161	189
Toothache
subjects affected / exposed	15 / 371 (4.04%)	24 / 371 (6.47%)
occurrences all number	18	30
Vomiting
subjects affected / exposed	50 / 371 (13.48%)	69 / 371 (18.60%)
occurrences all number	72	119
Skin and subcutaneous tissue disorders
Dry skin
subjects affected / exposed	22 / 371 (5.93%)	27 / 371 (7.28%)
occurrences all number	24	27
Erythema
subjects affected / exposed	21 / 371 (5.66%)	19 / 371 (5.12%)
occurrences all number	24	19
Night sweats
subjects affected / exposed	15 / 371 (4.04%)	24 / 371 (6.47%)
occurrences all number	21	29
Hyperhidrosis
subjects affected / exposed	26 / 371 (7.01%)	36 / 371 (9.70%)
occurrences all number	32	43
Pruritus
subjects affected / exposed	43 / 371 (11.59%)	39 / 371 (10.51%)
occurrences all number	50	48
Rash
subjects affected / exposed	86 / 371 (23.18%)	90 / 371 (24.26%)
occurrences all number	113	132
Skin lesion
subjects affected / exposed	17 / 371 (4.58%)	19 / 371 (5.12%)
occurrences all number	21	25
Renal and urinary disorders
Dysuria
subjects affected / exposed	19 / 371 (5.12%)	16 / 371 (4.31%)
occurrences all number	23	19
Pollakiuria
subjects affected / exposed	19 / 371 (5.12%)	14 / 371 (3.77%)
occurrences all number	20	14
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	121 / 371 (32.61%)	111 / 371 (29.92%)
occurrences all number	189	171
Bone pain
subjects affected / exposed	57 / 371 (15.36%)	58 / 371 (15.63%)
occurrences all number	75	75
Back pain
subjects affected / exposed	136 / 371 (36.66%)	133 / 371 (35.85%)
occurrences all number	209	214
Joint swelling
subjects affected / exposed	18 / 371 (4.85%)	19 / 371 (5.12%)
occurrences all number	21	19
Muscle spasms
subjects affected / exposed	83 / 371 (22.37%)	84 / 371 (22.64%)
occurrences all number	112	110
Muscular weakness
subjects affected / exposed	52 / 371 (14.02%)	45 / 371 (12.13%)
occurrences all number	58	56
Musculoskeletal chest pain
subjects affected / exposed	50 / 371 (13.48%)	49 / 371 (13.21%)
occurrences all number	60	66
Musculoskeletal pain
subjects affected / exposed	21 / 371 (5.66%)	28 / 371 (7.55%)
occurrences all number	24	29
Myalgia
subjects affected / exposed	17 / 371 (4.58%)	22 / 371 (5.93%)
occurrences all number	18	27
Neck pain
subjects affected / exposed	37 / 371 (9.97%)	30 / 371 (8.09%)
occurrences all number	43	37
Pain in jaw
subjects affected / exposed	12 / 371 (3.23%)	19 / 371 (5.12%)
occurrences all number	12	23
Pain in extremity
subjects affected / exposed	78 / 371 (21.02%)	76 / 371 (20.49%)
occurrences all number	97	118
Spinal pain
subjects affected / exposed	23 / 371 (6.20%)	15 / 371 (4.04%)
occurrences all number	31	19
Infections and infestations
Cystitis
subjects affected / exposed	20 / 371 (5.39%)	13 / 371 (3.50%)
occurrences all number	22	14
Cellulitis
subjects affected / exposed	26 / 371 (7.01%)	21 / 371 (5.66%)
occurrences all number	30	26
Bronchitis
subjects affected / exposed	52 / 371 (14.02%)	46 / 371 (12.40%)
occurrences all number	95	99
Influenza
subjects affected / exposed	20 / 371 (5.39%)	14 / 371 (3.77%)
occurrences all number	31	18
Herpes zoster
subjects affected / exposed	18 / 371 (4.85%)	23 / 371 (6.20%)
occurrences all number	19	23
Nasopharyngitis
subjects affected / exposed	62 / 371 (16.71%)	60 / 371 (16.17%)
occurrences all number	129	120
Oral herpes
subjects affected / exposed	11 / 371 (2.96%)	23 / 371 (6.20%)
occurrences all number	20	29
Pneumonia
subjects affected / exposed	23 / 371 (6.20%)	33 / 371 (8.89%)
occurrences all number	29	37
Sinusitis
subjects affected / exposed	17 / 371 (4.58%)	23 / 371 (6.20%)
occurrences all number	20	32
Respiratory tract infection
subjects affected / exposed	34 / 371 (9.16%)	38 / 371 (10.24%)
occurrences all number	67	90
Upper respiratory tract infection
subjects affected / exposed	84 / 371 (22.64%)	82 / 371 (22.10%)
occurrences all number	162	142
Urinary tract infection
subjects affected / exposed	56 / 371 (15.09%)	58 / 371 (15.63%)
occurrences all number	111	114
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	86 / 371 (23.18%)	100 / 371 (26.95%)
occurrences all number	113	117
Dehydration
subjects affected / exposed	22 / 371 (5.93%)	25 / 371 (6.74%)
occurrences all number	24	29
Hyperglycaemia
subjects affected / exposed	69 / 371 (18.60%)	120 / 371 (32.35%)
occurrences all number	121	255
Hypoalbuminaemia
subjects affected / exposed	21 / 371 (5.66%)	24 / 371 (6.47%)
occurrences all number	36	61
Hypokalaemia
subjects affected / exposed	91 / 371 (24.53%)	84 / 371 (22.64%)
occurrences all number	183	175
Hypocalcaemia
subjects affected / exposed	75 / 371 (20.22%)	73 / 371 (19.68%)
occurrences all number	169	160
Hypomagnesaemia
subjects affected / exposed	23 / 371 (6.20%)	41 / 371 (11.05%)
occurrences all number	32	67
Hypophosphataemia
subjects affected / exposed	16 / 371 (4.31%)	20 / 371 (5.39%)
occurrences all number	25	36
Hyponatraemia
subjects affected / exposed	17 / 371 (4.58%)	27 / 371 (7.28%)
occurrences all number	20	37

More information

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Were there any global substantial amendments to the protocol? Yes

15 Mar 2012

 Clarification of subject eligibility or study procedures.  Modification of screening requirements to conform to the standard of care and to enhance overall study conduct.  A revision was made to timing of when pregnancy testing must be completed. This change is in compliance with a recently approved, company-wide SOP for women of childbearing potential participating in clinical trials conducted by the Sponsor.  The inclusion criteria have been revised to clarify that refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto 006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old.  Instructions for what should be done with missed doses of lenalidomide or dexamethasone.  Revisions are made to exclusion criteria for clarity and consistency throughout the development program.  The requirement to discontinue elotuzumab and lenalidomide if a subject becomes pregnant.  Timing and details surrounding when certain study assessments are performed.  An update to the shelf-life of reconstituted elotuzumab.  Correction of typographical errors.

21 May 2014

 Elotuzumab infusion rate escalation plan added to decrease the infusion of elotuzumab to approximately 1 hour  Change to the UPEP efficacy testing to reduce the requirement of 24 hour urine collection in a subset of patients  Broadening of the medications that can be used for thromboprophylaxis.  Additional Clarifications in the protocol serve to reduce any ambiguity regarding study procedures, and provide additional guidance of the EBMT efficacy requirements.

21 Aug 2014

 Planned Interim Analysis will now take place at 70% of events (338 events) compared to the previous timepoint of 241 (50%) progression events  BPI-SF pain severity and pain interference will be evaluated as a secondary endpoint, and formal comparison between treatment arms will be conducted, though it will not be included hierarchical testing.  Addition of exploratory objectives to assess PFS at 1, 2 and 3 years and OS rates at 3, 4, 5 and 6 years.  Correction of typographical errors in the protocol and appendix documents.

17 Aug 2015

 Update statistical assumptions and protocol treatment rationale based on currently available published data  Clarify requirements for subjects with no measureable urine M protein at baseline  Inclusion of new PK/HAHA collection after Cycle 18  Inclusion of updated safety information regarding use of adequate contraception based on recent elotuzumab PK data.  Change recommended diluent volume of elotuzumab from fixed volumes to range of 100-500 mL.

24 Aug 2016

 To promote PFS rates from an exploratory objective to a secondary objective, and to expand the assessment of PFS rates from 1,2,3 years to cover years 1-5, inclusive.  Add Time-to-next-treatment (TTNT) as exploratory objective  Remove the following sentence from Section 4.3.1. “On the days of elotuzumab administration, the dose of lenalidomide is to be administered at least 2 hours after completion of elotuzumab dosing.  Change referencing of Experimental treatment arm of lenalidomide/dexamethasone + elotuzumab from LdE to E-Ld.  Add Section 8.3.7-Time to Next Treatment (TTNT)  Add Section 9.1.2.1 Source Documentation  Update Section 9.2.2 Study Drug Records

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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