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The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

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The EU Clinical Trials Register currently displays 44366 clinical trials with a EudraCT protocol, of which 7389 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

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Clinical Trial Results:
An Open-Label Study of Abiraterone Acetate in Subjects with Metastatic Castration- Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy

Summary
EudraCT number	2010-021425-13
Trial protocol	CZ HU ES IT LT DK GR
Global end of trial date	19 Oct 2015

Results information
Results version number	v1(current)
This version publication date	23 Sep 2016
First version publication date	23 Sep 2016
Other versions

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

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Trial information

Top of page

Sponsor protocol code

212082PCR3001

ISRCTN number

-

US NCT number

NCT01217697

WHO universal trial number (UTN)

-

Sponsor organisation name

Janssen Research and Development, LLC

Sponsor organisation address

Antwerpseweg 15-17, Beerse, Belgium, B-2340

Public contact

Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.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

19 Oct 2015

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

19 Oct 2015

Was the trial ended prematurely?

No

Main objective of the trial

The main objective of this study was to collect additional safety data during treatment with abiraterone acetate plus prednisone or prednisolone among subjects with metastatic castration-resistant prostate cancer (CRPC) who had failed 1 or 2 chemotherapy regimens, 1 of which contains a taxane base such as docetaxel, who reside in areas in which abiraterone acetate was not yet available through local healthcare providers,and who were not eligible for enrollment into an available ongoing clinical study of abiraterone acetate.

Protection of trial subjects

Safety evaluations included the collection of adverse events, evaluation of deaths, other serious adverse events and other significant adverse events, clinical laboratory tests, other safety observations (vital signs, physical examinations and Electrocardiograms).

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

17 Nov 2010

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 312

Country: Number of subjects enrolled

Brazil: 73

Country: Number of subjects enrolled

Canada: 100

Country: Number of subjects enrolled

Colombia: 2

Country: Number of subjects enrolled

Czech Republic: 107

Country: Number of subjects enrolled

Denmark: 57

Country: Number of subjects enrolled

Spain: 96

Country: Number of subjects enrolled

Greece: 61

Country: Number of subjects enrolled

Hong Kong: 17

Country: Number of subjects enrolled

Croatia: 20

Country: Number of subjects enrolled

Hungary: 84

Country: Number of subjects enrolled

Indonesia: 2

Country: Number of subjects enrolled

Italy: 550

Country: Number of subjects enrolled

Korea, Republic of: 45

Country: Number of subjects enrolled

Mexico: 63

Country: Number of subjects enrolled

Malaysia: 17

Country: Number of subjects enrolled

Poland: 50

Country: Number of subjects enrolled

Romania: 60

Country: Number of subjects enrolled

Russian Federation: 86

Country: Number of subjects enrolled

Singapore: 33

Country: Number of subjects enrolled

Thailand: 26

Country: Number of subjects enrolled

Taiwan: 23

Country: Number of subjects enrolled

United States: 432

Worldwide total number of subjects

2316

EEA total number of subjects

1085

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)

595

From 65 to 84 years

1667

85 years and over

54

Subject disposition

Top of page

Recruitment details

The study was conducted from 17 November 2010 to 19 October 2015.

Screening details

2,316 Subjects were enrolled in the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Abiraterone Acetate

Arm description

Subjects received abiraterone acetate 1000 milligram (mg) daily as four tablets of 250 mg orally and 5 mg prednisone or prednisolone twice daily as oral dose.

Arm type

Experimental

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available).

Investigational medicinal product name

Abiraterone Acetate

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received abiraterone acetate 1000 milligram (mg) daily as four tablets of 250 mg orally

Number of subjects in period 1	Abiraterone Acetate
Started	2316
Completed	0
Not completed	2316
Study Terminated by sponsor	59
Consent withdrawn by subject	153
Adverse Event	186
Market Authorization / Reimbursement	455
Death	178
Other	109
Lost to follow-up	18
Disease Progression	1142
Protocol deviation	16

Baseline characteristics

Top of page

Reporting group title

Abiraterone Acetate

Reporting group description

Subjects received abiraterone acetate 1000 milligram (mg) daily as four tablets of 250 mg orally and 5 mg prednisone or prednisolone twice daily as oral dose.

Reporting group values	Abiraterone Acetate	Total
Number of subjects	2316	2316
Title for AgeCategorical
Units: subjects
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	595	595
From 65 to 84 years	1667	1667
85 years and over	54	54
Title for AgeContinuous
Units: years
arithmetic mean (standard deviation)	70 ( 8.07 )	-
Title for Gender
Units: subjects
Male	2316	2316

End points

Top of page

Reporting group title

Abiraterone Acetate

Reporting group description

Subjects received abiraterone acetate 1000 milligram (mg) daily as four tablets of 250 mg orally and 5 mg prednisone or prednisolone twice daily as oral dose.

Subject analysis set title

Safety Analysis Population

Subject analysis set type

Safety analysis

Subject analysis set description

Saefty analysis set included all subjects who received at least one dose of primary study drug (Abiraterone acetate)

Primary: Number of Subjects With Adverse Events (A.Es)

Top of page

End point title

Number of Subjects With Adverse Events (A.Es) ^[1]

End point description

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

End point type

Primary

End point timeframe

From the time of signing the informed consent to the time of the End-of-Study Visit (30 days after discontinuation of study drug)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analysis was not reported for this endpoint as inferential analysis was not performed as planned.

End point values	Abiraterone Acetate
Number of subjects analysed	2316 ^[2]
Units: Subjects
Treatment-emergent serious or clinically important	1166
Grade 3-4 treatment emergent A.Es	980
Treatment-emergent serious A.Es	682
Treatment-emergent A.Es leading to treatment	385
Treatment-emergent A.Es leading to death	248

Notes
[2] - Safety analysis population

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From the time of signing the informed consent to the time of the End-of-Study Visit (30 days after discontinuation of study drug)

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

14.0

Reporting group title

Abiraterone Acetate

Reporting group description

Subjects received abiraterone acetate 1000 milligram (mg) daily as four tablets of 250 mg orally and 5 mg prednisone or prednisolone twice daily as oral dose.

Serious adverse events	Abiraterone Acetate
Total subjects affected by serious adverse events
subjects affected / exposed	818 / 2316 (35.32%)
number of deaths (all causes)	248
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Basal Cell Carcinoma
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Carcinoid Tumour of the Caecum
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastric Cancer
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Colon Cancer
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Lung Adenocarcinoma
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lung Neoplasm Malignant
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Malignant Melanoma
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Malignant Pleural Effusion
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Meningeal Neoplasm
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metastases to Bone Marrow
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Metastases to Bone
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metastases to Central Nervous System
subjects affected / exposed	6 / 2316 (0.26%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 1
Metastases to Lung
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Metastases to Liver
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Metastatic Pain
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Metastases to Meninges
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Neoplasm Malignant
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Pancreatic Carcinoma
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Pancreatic Neoplasm
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Prostate Cancer
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 4
Prostate Cancer Metastatic
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 3
Rectal Cancer
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Tumour Flare
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Tumour Pain
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Vascular disorders
Arterial Occlusive Disease
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Circulatory Collapse
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Deep Vein Thrombosis
subjects affected / exposed	8 / 2316 (0.35%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 0
Haematoma
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Haemorrhage
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Hypertension
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hypotension
subjects affected / exposed	8 / 2316 (0.35%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 2
Peripheral Ischaemia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vascular Compression
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Shock
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Venous Thrombosis Limb
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Surgical and medical procedures
Aortic Valve Replacement
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Coronary Angioplasty
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Fasciectomy
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hernia Repair
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hospitalisation
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Photon Radiation Therapy to Brain
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lung Lobectomy
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Radiotherapy
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Spinal Decompression
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Spinal Fusion Surgery
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Stent Removal
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	15 / 2316 (0.65%)
occurrences causally related to treatment / all	0 / 15
deaths causally related to treatment / all	0 / 4
Chest Discomfort
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Chest Pain
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 1
Death
subjects affected / exposed	12 / 2316 (0.52%)
occurrences causally related to treatment / all	0 / 12
deaths causally related to treatment / all	0 / 12
Device Failure
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Discomfort
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Disease Progression
subjects affected / exposed	25 / 2316 (1.08%)
occurrences causally related to treatment / all	0 / 25
deaths causally related to treatment / all	0 / 22
Drug Interaction
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Fatigue
subjects affected / exposed	15 / 2316 (0.65%)
occurrences causally related to treatment / all	0 / 16
deaths causally related to treatment / all	0 / 4
General Physical Health Deterioration
subjects affected / exposed	39 / 2316 (1.68%)
occurrences causally related to treatment / all	0 / 40
deaths causally related to treatment / all	0 / 31
Hernia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hyperpyrexia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Malaise
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Multi-Organ Failure
subjects affected / exposed	9 / 2316 (0.39%)
occurrences causally related to treatment / all	0 / 9
deaths causally related to treatment / all	0 / 9
Medical Device Complication
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Non-Cardiac Chest Pain
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Oedema
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Oedema Peripheral
subjects affected / exposed	10 / 2316 (0.43%)
occurrences causally related to treatment / all	0 / 10
deaths causally related to treatment / all	0 / 0
Pain
subjects affected / exposed	20 / 2316 (0.86%)
occurrences causally related to treatment / all	0 / 22
deaths causally related to treatment / all	0 / 1
Performance Status Decreased
subjects affected / exposed	6 / 2316 (0.26%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 6
Sudden Death
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Pyrexia
subjects affected / exposed	21 / 2316 (0.91%)
occurrences causally related to treatment / all	0 / 29
deaths causally related to treatment / all	0 / 0
Reproductive system and breast disorders
Breast Pain
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Prostatic Obstruction
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute Interstitial Pneumonitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Acute Respiratory Failure
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 3
Chronic Obstructive Pulmonary Disease
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Cough
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Dyspnoea
subjects affected / exposed	15 / 2316 (0.65%)
occurrences causally related to treatment / all	0 / 17
deaths causally related to treatment / all	0 / 2
Epistaxis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Haemoptysis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Interstitial Lung Disease
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hydrothorax
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Laryngeal Oedema
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lung Disorder
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Pleural Effusion
subjects affected / exposed	9 / 2316 (0.39%)
occurrences causally related to treatment / all	0 / 10
deaths causally related to treatment / all	0 / 1
Pneumonia Aspiration
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Pneumonitis
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Pneumothorax
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Pulmonary Congestion
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pulmonary Embolism
subjects affected / exposed	12 / 2316 (0.52%)
occurrences causally related to treatment / all	0 / 12
deaths causally related to treatment / all	0 / 2
Pulmonary Microemboli
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pulmonary Oedema
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Respiratory Arrest
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Respiratory Disorder
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Respiratory Failure
subjects affected / exposed	10 / 2316 (0.43%)
occurrences causally related to treatment / all	0 / 10
deaths causally related to treatment / all	0 / 10
Psychiatric disorders
Agitation
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Confusional State
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Delirium
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Depression
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Disorientation
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Mental Status Changes
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hallucination
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Suicidal Ideation
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Suicide Attempt
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Investigations
Biopsy Liver
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Blood Creatinine Increased
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Haemoglobin Decreased
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hepatic Enzyme Increased
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
International Normalised Ratio Increased
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Liver Function Test Abnormal
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Platelet Count Decreased
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Prostatic Specific Antigen Increased
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Urine Output Decreased
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Injury, poisoning and procedural complications
Accident
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Accidental Overdose
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Ankle Fracture
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Clavicle Fracture
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Cervical Vertebral Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Compression Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cystitis Radiation
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Fall
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 0
Femoral Neck Fracture
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Femur Fracture
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 2
Foot Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hand Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Head Injury
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Humerus Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lumbar Vertebral Fracture
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Open Wound
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Overdose
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Patella Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pelvic Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Post Procedural Haematuria
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Rib Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Radius Fracture
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Spinal Compression Fracture
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Spinal Fracture
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Subdural Haematoma
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 2
Subdural Haemorrhage
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Thoracic Vertebral Fracture
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Toxicity to Various Agents
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Transfusion Reaction
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Traumatic Brain Injury
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Upper Limb Fracture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Wound Secretion
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac disorders
Acute Coronary Syndrome
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 3
Acute Myocardial Infarction
subjects affected / exposed	6 / 2316 (0.26%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 0
Angina Pectoris
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Angina Unstable
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Arrhythmia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Atrial Fibrillation
subjects affected / exposed	8 / 2316 (0.35%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 0
Atrial Flutter
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Atrioventricular Block
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bundle Branch Block Left
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac Arrest
subjects affected / exposed	8 / 2316 (0.35%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 8
Cardiac Disorder
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac Failure
subjects affected / exposed	9 / 2316 (0.39%)
occurrences causally related to treatment / all	0 / 9
deaths causally related to treatment / all	0 / 4
Cardiac Failure Congestive
subjects affected / exposed	6 / 2316 (0.26%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 4
Cardio-Respiratory Arrest
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 4
Cardio-Respiratory Distress
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Cardiovascular Disorder
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Myocardial Infarction
subjects affected / exposed	6 / 2316 (0.26%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 1
Intracardiac Thrombus
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Myocardial Ischaemia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Palpitations
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pericardial Effusion
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Supraventricular Tachycardia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Tachycardia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ventricular Tachycardia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Nervous system disorders
Altered State of Consciousness
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Brain Oedema
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Central Nervous System Lesion
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Cerebral Haemorrhage
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Cerebral Infarction
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Cerebral Ischaemia
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Cerebrovascular Accident
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 5
Cognitive Disorder
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Coma
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Convulsion
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cranial Nerve Disorder
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Depressed Level of Consciousness
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Diabetic Coma
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Diabetic Neuropathy
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Dizziness
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Dysarthria
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Encephalopathy
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Epilepsy
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Haemorrhage Intracranial
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Hemiparesis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Headache
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Hemiplegia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Iiird Nerve Paralysis
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Lethargy
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Loss of Consciousness
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metabolic Encephalopathy
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Nerve Root Compression
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Monoparesis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Neuralgia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Neurological Symptom
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Paraparesis
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 1
Paraplegia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Peripheral Sensory Neuropathy
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Presyncope
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Sedation
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Sciatica
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Spinal Cord Compression
subjects affected / exposed	28 / 2316 (1.21%)
occurrences causally related to treatment / all	0 / 28
deaths causally related to treatment / all	0 / 2
Syncope
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Trigeminal Neuralgia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Transient Ischaemic Attack
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Blood and lymphatic system disorders
Anaemia
alternative assessment type: Systematic
subjects affected / exposed	50 / 2316 (2.16%)
occurrences causally related to treatment / all	0 / 53
deaths causally related to treatment / all	0 / 12
Anaemia Macrocytic
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bone Marrow Failure
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Disseminated Intravascular Coagulation
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 3
Febrile Neutropenia
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Leukopenia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Neutropenia
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Pancytopenia
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Thrombocytopenia
subjects affected / exposed	8 / 2316 (0.35%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 1
Thrombotic Thrombocytopenic Purpura
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Ear and labyrinth disorders
Vertigo Positional
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vertigo
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Eye disorders
Glaucoma
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Diplopia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Visual Impairment
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Retinal Vein Occlusion
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Abdominal Adhesions
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Abdominal Distension
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Abdominal Mass
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Abdominal Pain
subjects affected / exposed	9 / 2316 (0.39%)
occurrences causally related to treatment / all	0 / 10
deaths causally related to treatment / all	0 / 1
Abdominal Pain Upper
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Anal Fistula
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Anal Haemorrhage
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ascites
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Colonic Obstruction
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Colitis
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Constipation
subjects affected / exposed	7 / 2316 (0.30%)
occurrences causally related to treatment / all	0 / 7
deaths causally related to treatment / all	0 / 1
Diarrhoea
subjects affected / exposed	11 / 2316 (0.47%)
occurrences causally related to treatment / all	0 / 11
deaths causally related to treatment / all	0 / 1
Diverticulum
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Diverticulum Intestinal Haemorrhagic
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Duodenal Ulcer
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Dysphagia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Erosive Oesophagitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Enterovesical Fistula
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastritis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal Hypomotility
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal Haemorrhage
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Haematemesis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gingivitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hiatus Hernia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ileus
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Impaired Gastric Emptying
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Intestinal Obstruction
subjects affected / exposed	7 / 2316 (0.30%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 1
Large Intestine Perforation
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Lower Gastrointestinal Haemorrhage
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Nausea
subjects affected / exposed	7 / 2316 (0.30%)
occurrences causally related to treatment / all	0 / 13
deaths causally related to treatment / all	0 / 0
Mouth Haemorrhage
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Proctalgia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pancreatitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Obstruction Gastric
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Rectal Haemorrhage
subjects affected / exposed	6 / 2316 (0.26%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 1
Retroperitoneal Haemorrhage
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vomiting
subjects affected / exposed	13 / 2316 (0.56%)
occurrences causally related to treatment / all	0 / 20
deaths causally related to treatment / all	0 / 0
Small Intestinal Obstruction
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Upper Gastrointestinal Haemorrhage
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Hepatobiliary disorders
Cholangitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cholecystitis Acute
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Cholecystitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hepatic Function Abnormal
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hepatic Failure
subjects affected / exposed	6 / 2316 (0.26%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 4
Hepatitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hepatorenal Failure
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Hyperbilirubinaemia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Liver Injury
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Renal and urinary disorders
Bladder Obstruction
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Dysuria
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Bladder Spasm
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Haematuria
subjects affected / exposed	30 / 2316 (1.30%)
occurrences causally related to treatment / all	0 / 41
deaths causally related to treatment / all	0 / 2
Hydronephrosis
subjects affected / exposed	10 / 2316 (0.43%)
occurrences causally related to treatment / all	0 / 10
deaths causally related to treatment / all	0 / 1
Nephrolithiasis
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Nephropathy Toxic
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Obstructive Uropathy
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Renal Failure
subjects affected / exposed	7 / 2316 (0.30%)
occurrences causally related to treatment / all	0 / 7
deaths causally related to treatment / all	0 / 2
Renal Impairment
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Renal Failure Acute
subjects affected / exposed	16 / 2316 (0.69%)
occurrences causally related to treatment / all	0 / 16
deaths causally related to treatment / all	0 / 5
Ureteric Rupture
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Urethral Stenosis
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Urinary Incontinence
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Urinary Retention
subjects affected / exposed	12 / 2316 (0.52%)
occurrences causally related to treatment / all	0 / 14
deaths causally related to treatment / all	0 / 0
Urinary Tract Obstruction
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Endocrine disorders
Adrenal Insufficiency
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	13 / 2316 (0.56%)
occurrences causally related to treatment / all	0 / 14
deaths causally related to treatment / all	0 / 0
Back Pain
subjects affected / exposed	52 / 2316 (2.25%)
occurrences causally related to treatment / all	0 / 58
deaths causally related to treatment / all	0 / 3
Bone Pain
subjects affected / exposed	16 / 2316 (0.69%)
occurrences causally related to treatment / all	0 / 16
deaths causally related to treatment / all	0 / 3
Bursitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Groin Pain
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Haemarthrosis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lumbar Spinal Stenosis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Muscle Spasms
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Muscular Weakness
subjects affected / exposed	7 / 2316 (0.30%)
occurrences causally related to treatment / all	0 / 7
deaths causally related to treatment / all	0 / 0
Musculoskeletal Chest Pain
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Musculoskeletal Pain
subjects affected / exposed	8 / 2316 (0.35%)
occurrences causally related to treatment / all	0 / 9
deaths causally related to treatment / all	0 / 0
Myalgia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Neck Pain
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Osteoarthritis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Osteonecrosis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Osteonecrosis of Jaw
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pain in Extremity
subjects affected / exposed	7 / 2316 (0.30%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 0
Pathological Fracture
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Rhabdomyolysis
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Infections and infestations
Abdominal Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Abscess Limb
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Anal Abscess
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Alveolar Osteitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Appendicitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Arteriovenous Fistula Site Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Arthritis Infective
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bacteraemia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Bacterial Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Biliary Tract Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Biliary Sepsis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bronchitis
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Cellulitis
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Bronchopneumonia
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Clostridium Difficile Colitis
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Cellulitis Orbital
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cystitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Device Related Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Diverticulitis
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Enterocolitis Infectious
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Escherichia Bacteraemia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Escherichia Sepsis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Eye Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastroenteritis
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Gastrointestinal Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastroenteritis Viral
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Haematoma Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infection
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Infective Exacerbation of Chronic Obstructive Airways Disease
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Influenza
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Laryngitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lower Respiratory Tract Infection
subjects affected / exposed	6 / 2316 (0.26%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 0
Lobar Pneumonia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ludwig Angina
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Necrotising Fasciitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lung Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Pneumonia
subjects affected / exposed	40 / 2316 (1.73%)
occurrences causally related to treatment / all	0 / 44
deaths causally related to treatment / all	0 / 8
Osteomyelitis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Post Procedural Sepsis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Psoas Abscess
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Pulmonary Tuberculosis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pyelonephritis
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Pyelonephritis Acute
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory Tract Infection
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Salmonella Bacteraemia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Salmonella Sepsis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Salmonellosis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Scrotal Abscess
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Sepsis
subjects affected / exposed	18 / 2316 (0.78%)
occurrences causally related to treatment / all	0 / 18
deaths causally related to treatment / all	0 / 9
Septic Shock
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Staphylococcal Sepsis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Upper Respiratory Tract Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Urinary Tract Infection
subjects affected / exposed	34 / 2316 (1.47%)
occurrences causally related to treatment / all	0 / 38
deaths causally related to treatment / all	0 / 2
Urinary Tract Infection Bacterial
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Urosepsis
subjects affected / exposed	25 / 2316 (1.08%)
occurrences causally related to treatment / all	0 / 31
deaths causally related to treatment / all	0 / 3
Viral Upper Respiratory Tract Infection
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Wound Sepsis
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metabolism and nutrition disorders
Cachexia
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Decreased Appetite
subjects affected / exposed	5 / 2316 (0.22%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Dehydration
subjects affected / exposed	18 / 2316 (0.78%)
occurrences causally related to treatment / all	0 / 19
deaths causally related to treatment / all	0 / 2
Diabetes Mellitus
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Diabetes Mellitus Inadequate Control
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Failure to Thrive
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Fluid Retention
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hypercalcaemia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hyperkalaemia
subjects affected / exposed	4 / 2316 (0.17%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Hypoglycaemia
subjects affected / exposed	3 / 2316 (0.13%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Hypokalaemia
subjects affected / exposed	7 / 2316 (0.30%)
occurrences causally related to treatment / all	0 / 7
deaths causally related to treatment / all	0 / 0
Hyponatraemia
subjects affected / exposed	2 / 2316 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Hypophosphataemia
subjects affected / exposed	1 / 2316 (0.04%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0

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

Non-serious adverse events	Abiraterone Acetate
Total subjects affected by non serious adverse events
subjects affected / exposed	149 / 2316 (6.43%)
Investigations
Blood Alkaline Phosphatase Increased
alternative assessment type: Systematic
subjects affected / exposed	149 / 2316 (6.43%)
occurrences all number	172

More information

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Were there any global substantial amendments to the protocol? Yes

17 Sep 2010

Amendment clarified disease progression assessments in addition to other minor clarifications and corrections: Prostate-specific antigen (PSA) progression and clinical progression assessments were clarified, Key results from Study COU-AA-301 were summarized and included in the study design rationale as background for this early access protocol (EAP), Per the request from the United States (US) Food and Drug Administration, an exclusion criterion for prior systemic treatment with an azole drug, For example (e.g.), fluconazole, itraconazole, ketoconazole) within 1 month of study start was added. This was included because the safety of subjects with recent exposure to azoles and abiraterone had not been tested. Quality-of-Life (QoL) and medical resource utilization (MRU) assessments were expanded to be performed at non-European as well as European sites.

20 May 2011

Amendment added the following information in addition to the correction of minor errors: The end-of-study definition was revised with further clarification of the last assessment of the last subject. The dosage of abiraterone acetate was clarified to be once daily and not in divided doses Over the course of the day. References to sites in Europe for Patient-reported outcome/Medical resource utilization (PRO/MRU) assessments were removed as they may also be assessed at non-European sites. An attachment was added to clearly define PSA progression, to determine the eligibility of a subject for the study (referred to in the inclusion criteria). Concomitant therapy was added as an exclusion criterion. Location of recording clinically important signs and symptoms in the case report form (CRF) was specified. Clarification was made to inclusion criterion. Albumin was added to the serum chemistry panel to be consistent with other sections of the protocol. The definition of a serious adverse event (SAE) was updated, and the timeframe for case report form transmission to the sponsor was changed per company standards. Assessment of physical examination and measurement of blood pressure and weight were added to the CRF. Information on management of Grade 2 hypokalemia was added.

07 May 2012

Amendment added the following information in addition to the corrections of minor errors: Language for the reporting of all clinically important adverse events (AEs) to the sponsor was changed back to the wording in the original protocol. The timeframe for obtaining an electrocardiogram (ECG) in the screening period was changed to be consistent with the requirement associated with multiple gated acquisition (MUGA) scans. Assessment of serum testosterone level at screening was expanded to account for those areas where it was not the standard of care. The requirement for completion of the MRU questionnaire at Cycle 1 Day 1 was removed. An allowance for all study procedures to be conducted within a window of ± 2 days was added. Serum, magnesium, amylase, and lipase were added to the procedures required at the end of study visit. The term “investigator” was removed from “investigator prescribed” when referring to prednisone. The definition of uncontrolled hypertension in the exclusion criteria was clarified. Other azole drugs were added to list of prohibited medications. The upper limit of Grade 1 and the lower limit of Grade 2 increases in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were amended from 2.5 x the upper limit of normal (ULN) to 3x ULN.

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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