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Clinical Trial Results:
STI571 Prospective International RandomIsed Trial 2 - A phase III, prospective randomised comparison of imatinib (STI571, Glivec/Gleevec) 400mg daily versus dasatinib (Sprycel) 100mg daily in patients with newly-diagnosed chronic phase chronic myeloid leukaemia.

Summary
EudraCT number	2007-006185-15
Trial protocol	GB
Global end of trial date	07 Mar 2018

Results information
Results version number	v1(current)
This version publication date	08 Jun 2019
First version publication date	08 Jun 2019
Other versions

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

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Trial information

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Sponsor protocol code

SPIRIT 2

ISRCTN number

ISRCTN54923521

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Newcastle-upon-Tyne Hospitals NHS Foundation Trust

Sponsor organisation address

Level 1, Regent Point, Regent Farm Road, Newcastle upon Tyne, United Kingdom, NE3 3HD

Public contact

Professor Stephen O'Brien, Newcastle Clinical Trials Unit, 0044 0191 208 2522, stephen.o'brien@ncl.ac.uk

Scientific contact

Professor Stephen O'Brien, Newcastle Clinical Trials Unit, 0044 0191 208 2522, stephen.o'brien@ncl.ac.uk

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

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

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

Analysis stage

Final

Date of interim/final analysis

21 May 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

07 Mar 2018

Global end of trial reached?

Yes

Global end of trial date

07 Mar 2018

Was the trial ended prematurely?

Main objective of the trial

To compare 5-year Event Free Survival (EFS) between the two treatment arms. The study is powered to demonstrate superiority of the dasatinib arm over the imatinib arm.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

none

Evidence for comparator

Actual start date of recruitment

07 Aug 2008

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 814

Worldwide total number of subjects

814

EEA total number of subjects

814

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

618

From 65 to 84 years

189

85 years and over

Subject disposition

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Recruitment details

Patients were recruited from haematology clinics in UK hospitals from August 2007 until end of February 2013. Eligible patients were screened by haematology consultants and then written informed consent obtained.

Screening details

Patients had blood tests (haematology and biochemistry), a bone marrow sample (aspirate and trephine) taken and a physical examination performed. Medical history and details of any concomitant diseases and any treatment given post diagnosis was noted. If patient met inclusion criteria and none of the exclusion criteria, they were then randomised.

Period 1 title

Treatment (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Arm A

Arm description

Imatinib 400mg per day

Arm type

Active comparator

Investigational medicinal product name

Imatinib

Investigational medicinal product code

Other name

Glivec

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One 400mg tablet to be taken orally each day with water.

Arm B

Arm description

Dasatinib 100mg daily

Arm type

Experimental

Investigational medicinal product name

Dasatinib

Investigational medicinal product code

Other name

Sprycel

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One 100mg tablet to be taken once a day, orally, with water.

Number of subjects in period 1 ^[1]	Arm A	Arm B
Started	406	406
Completed	194	230
Not completed	212	176
Consent withdrawn by subject	2	1
Adverse event, non-fatal	68	123
Pregnancy	2	4
Patient did not want to continue first line drug	8	8
patient developed another concomitant condition	4	-
joined another clinical trial	-	1
developed a concomitant condition	-	8
Lost to follow-up	4	3
Lack of efficacy	49	20
Inadequate PCR response/loss of PCR response	67	6
patient joined another clinical trial	7	-
Protocol deviation	1	2

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Only 812 (406 in each arm), out of 814 recruited, received treatment. So all study results are based on FAS/SAF analysis population, which consists actually on 812 total patients.

Baseline characteristics

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Reporting group title

Arm A

Reporting group description

Imatinib 400mg per day

Reporting group title

Arm B

Reporting group description

Dasatinib 100mg daily

Reporting group values	Arm A	Arm B	Total
Number of subjects	406	406	812
Age categorical
Units: Subjects
Adults (18-64 years)	309	308	617
From 65-84 years	96	92	188
85 years and over	1	6	7
Age continuous
Units: years
arithmetic mean (standard deviation)	53.3 ( 14.7 )	53.1 ( 15.4 )	-
Gender categorical
Male and female patients were selected from haematology clinics across the UK
Units: Subjects
Female	165	155	320
Male	241	251	492
Sokal Score
prognostic indicator at baseline Good prognosis (<0.8) Moderate prognosis (0.8-1.2) Poor prognosis (>1.2)
Units: Subjects
Good prognosis	80	94	174
Moderate prognosis	86	78	164
Poor prognosis	52	55	107
not recorded	188	179	367
Hasford Score
prognostic indicator measured at baseline Low risk (equal to or less than score of 780) Intermediate risk (>780 to less than or equal to 1480) High risk (>1480)
Units: Subjects
Low risk	83	84	167
Intermediate risk	99	107	206
high risk	23	17	40
not recorded	201	198	399
EUTOS Score
Prognostic score calculated at baseline Low risk (less than or equal to 87) High risk (>87)
Units: Subjects
Low risk	269	255	524
High risk	52	46	98
Not recorded	85	105	190
ELTS Score
EUTOS long term survival score. Prognostics score calculated at baseline Low risk (less than or equal to 1.5680) Intermediate risk (>1.5680 to less than or equal to 2.2185) High risk (>2.2185)
Units: Subjects
Low risk	122	133	255
Intermediate risk	62	67	129
High risk	34	27	61
Not recorded	188	179	367
BCR-ABL transcript type
breakpoint recorded at baseline from PCR sample
Units: Subjects
E13A2	142	146	288
E14A2	197	187	384
E13A2+E14A2	60	61	121
E1A2	1	2	3
not recorded	6	10	16
Time since CML diagnosis
number of days between diagnosis and start of treatment
Units: days
arithmetic mean (full range (min-max))	15 (0 to 94)	16 (0 to 91)	-

Subject analysis set title

FAS

Subject analysis set type

Full analysis

Subject analysis set description

The FAS is defined as all randomised patients who received study medication at least once. Patients will be analysed according to the treatment group to which they were randomised, rather than by the actual treatment they were administered. The FAS is the primary population of interest for all efficacy analyses.

Subject analysis set title

Safety Set

Subject analysis set type

Safety analysis

Subject analysis set description

All patients who are randomised into the study and who received study medication at least once will be considered evaluable for the Safety Set. This is the same definition as the FAS. However, in the event that a patient receives study medication other than that to which they have been randomised, analyses based on the Safety Set will be performed using the actual treatment group that was administered and so will be different to the FAS. All safety tables will be based on the Safety Set.

Subject analysis sets values	FAS	Safety Set
Number of subjects	812	812
Age categorical
Units: Subjects
Adults (18-64 years)	617	617
From 65-84 years	188	188
85 years and over	7	7
Age continuous
Units: years
arithmetic mean (standard deviation)	53.2 ( 15.0 )	53.2 ( 15.0 )
Gender categorical
Male and female patients were selected from haematology clinics across the UK
Units: Subjects
Female	320	320
Male	492	492
Sokal Score
prognostic indicator at baseline Good prognosis (<0.8) Moderate prognosis (0.8-1.2) Poor prognosis (>1.2)
Units: Subjects
Good prognosis
Moderate prognosis
Poor prognosis
not recorded
Hasford Score
prognostic indicator measured at baseline Low risk (equal to or less than score of 780) Intermediate risk (>780 to less than or equal to 1480) High risk (>1480)
Units: Subjects
Low risk
Intermediate risk
high risk
not recorded
EUTOS Score
Prognostic score calculated at baseline Low risk (less than or equal to 87) High risk (>87)
Units: Subjects
Low risk
High risk
Not recorded
ELTS Score
EUTOS long term survival score. Prognostics score calculated at baseline Low risk (less than or equal to 1.5680) Intermediate risk (>1.5680 to less than or equal to 2.2185) High risk (>2.2185)
Units: Subjects
Low risk
Intermediate risk
High risk
Not recorded
BCR-ABL transcript type
breakpoint recorded at baseline from PCR sample
Units: Subjects
E13A2
E14A2
E13A2+E14A2
E1A2
not recorded
Time since CML diagnosis
number of days between diagnosis and start of treatment
Units: days
arithmetic mean (full range (min-max))

End points

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Reporting group title

Arm A

Reporting group description

Imatinib 400mg per day

Reporting group title

Arm B

Reporting group description

Dasatinib 100mg daily

Subject analysis set title

FAS

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Safety Set

Subject analysis set type

Safety analysis

Subject analysis set description

Primary: Event free survival at 5 years

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End point title

Event free survival at 5 years

End point description

To establish whether dasatinib is superior to imatinib in terms of event free survival censored at 5 years. An event includes death from any cause, disease progression, loss of complete haematological response (CHR), increasing white blood cell count, or loss of major cytogenetic response (MCR).

End point type

Primary

End point timeframe

5 years

End point values	Arm A	Arm B
Number of subjects analysed	406	406
Units: number of patients
Death: non CML related	23	21
Death: CML related	2	0
Disease progression - blast crisis	7	6
disease progression - accelerated phase	4	4
Loss of CHR	5	3
Loss of MCR	2	1
Increasing white blood cell count	0	0
No event	363	371

Attachments

Kaplan-Meier Plot of Event Free Survival

Event-Free Survival Kaplan-Meier Analysis

Statistical analysis description

An event includes: death (any cause), disease progression, loss of CHR, increase in WBC count, or loss of MCR. See protocol for full details. Event-free survival is calculated as (Date of event - Date of first dose of study medication)/30.4. Patients who have not experienced an event within 5 years are censored at the earliest of (date of last visit, or the date of first dose of study medication + 1826.25 days).

Comparison groups

Arm B v Arm A

Number of subjects included in analysis

812

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.318

Method

Logrank

Confidence interval

Event-Free Survival Cox Proportional Hazard Model

Statistical analysis description

An event includes: death (any cause), disease progression, loss of CHR, increase in WBC count, or loss of MCR. See protocol for full details. Event-free survival is calculated as (Date of event - Date of first dose of study medication)/30.4. Patients who have not experienced an event within 5 years are censored at the earliest of (Date of last visit, or the date of first dose of study medication + 1826.25 days).

Comparison groups

Arm B v Arm A

Number of subjects included in analysis

812

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.319

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.797

Confidence interval

level

95%

sides

2-sided

lower limit

0.51

upper limit

1.245

Notes
[1] - Analysis is based on a Cox proportional hazards model with treatment group included as an explanatory variable.

Sensitivity Analysis

Statistical analysis description

Event-Free Survival Cox Proportional Hazards Model (Sensitivity Analysis) An event includes: death (any cause), disease progression, loss of CHR, increase in WBC count, or loss of MCR. See protocol for full details. Event-free survival is calculated as (Date of event - Date of first dose of study medication)/30.4. Patients who have not experienced an event within 5 years are censored at the earliest of (Date of last visit, or the date of first dose of study medication + 1826.25 days).

Comparison groups

Arm B v Arm A

Number of subjects included in analysis

812

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

= 0.216

Method

Regression, Cox

Parameter type

Cox proportional hazard

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

0.476

upper limit

1.183

Notes
[2] - Analysis is based on a Cox proportional hazards model with treatment group, gender, BCR-ABL transcript, dose received in first 3 months (<90% or =90%) included as explanatory variables.

Secondary: Rate of complete cytogenetic response

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End point title

Rate of complete cytogenetic response

End point description

The proportion of patients achieving CCR according to the G banding . For G-banding: CCR is defined as 0% Philadelphia chromosome positive metaphases in bone marrow cells. Data is presented as observed and worst case data where worst case presumes patients with missing cytogenetic responses are non-responders. Worst case data is presented as attachment.

End point type

Secondary

End point timeframe

24 months

End point values	Arm A	Arm B
Number of subjects analysed	406	406
Units: number of patients
Yes	129	173
No	28	27
not evaluable	249	206

Attachments

Untitled (Filename: Complete cytogenetic response by G-banding - worst case data.pdf)

Complete Cytogenetic Response(CCR) (Observed Data)

Comparison groups

Arm B v Arm A

Number of subjects included in analysis

812

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.26

Method

Chi-squared

Confidence interval

Secondary: Rate of treatment failure

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End point title

Rate of treatment failure

End point description

Treatment failure includes all events, intolerance (such that the patient has to stop study drug permanently) , failure to achieve complete haematological response (CHR) after 6 months of treatment, failure to achieve major cytogenetic response (MCR) after 12 months of treatment, failure to achieve CCR after 24 months of treatment, failure to achieve adequate PCR (defined as >10% after 3 months treatment, >1% after 6 months treatment and >0/1% after 12 months treatment) and loss of adequate PCR response (as assessed by investigator).

End point type

Secondary

End point timeframe

5 years

End point values	Arm A	Arm B
Number of subjects analysed	406	406
Units: Number of patients
Death: non CML related	14	12
Death: CML related	0	0
Disease progression - blast crisis	7	4
Disease progression - accelerated phase	0	4
Loss of CHR	4	0
Loss of MCR	2	1
increasing WBC count	0	0
Intolerance	69	120
Failure to achieve CHR after 6 mths of treatment	1	0
Failure to achieve MCR after 12 months of treatmen	16	7
Failure to achieve CCR after 24 mths of treatment	10	1
Failure to achieve adequate PCR	54	6
Loss of adequate PCR response	12	1
No treatment failure	217	250

Attachments

TIME TO TREATMENT FAILURE KAPLAN-MEIER ANALYSIS

Time to Treatment Failure Kaplan-Meier Analysis

Statistical analysis description

Time to treatment failure is calculated as (Date of failure - Date of first dose of study medication)/30.4. Patients who have not experienced treatment failure at 5 years are censored at the earliest of (date of last visit, or the date of first dose of study medication + 1826.25 days).

Comparison groups

Arm B v Arm A

Number of subjects included in analysis

812

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Logrank

Confidence interval

Secondary: Rate of complete haematological response

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End point title

Rate of complete haematological response

End point description

To compare the dates of complete haematological response (CHR) in patients on each arm after 6 months of treatment. Patients were not evaluable if the data was missing at the timepoint required. Data were analysed as observed data and worst cases data where worst case presumes patients with a missing response are non-responders.

End point type

Secondary

End point timeframe

6 months

End point values	Arm A	Arm B
Number of subjects analysed	406	406
Units: number of patients
yes	371	378
no	22	5
not evaluable	13	23

Attachments

Untitled (Filename: Complete haematological response (worst case data).pdf)

Complete Haematologic Response(CHR)(Observed Data)

Statistical analysis description

Duration of CHR calculated as (earliest of (Date of loss of CHR, or date of treatment failure) - Date of first documentation of CHR)/30.4.

Comparison groups

Arm B v Arm A

Number of subjects included in analysis

812

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

Chi-squared

Confidence interval

Secondary: Level of molecular responses by PCR on first line therapy

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End point title

Level of molecular responses by PCR on first line therapy

End point description

The level of molecular responses (BCR-ABL/ABL ratio by real time polymerase chain reaction (international scale) (PCR) in each of the treatment arms.

End point type

Secondary

End point timeframe

MR1 (<10% )at 3 months, MR2 (<1%) at 6 months, MR3 (<0.1%) at 12 months, MR4.5 (<0.032) at any time

End point values	Arm A	Arm B
Number of subjects analysed	406	406
Units: number of patients
MR1 yes	264	305
MR1 no	115	84
not evaluable for MR1	27	17
MR2 yes	202	277
MR2 no	113	90
not evaluable for MR2	91	39
MR3 yes	181	252
MR3 no	92	100
not evaluable for MR3	133	54
MR4.5 yes	231	313
MR4.5 no	31	27
not evaluable for MR4	144	66

No statistical analyses for this end point

Secondary: Quality of Life

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End point title

Quality of Life

End point description

Quality of life was assessed between the 2 arms. EQ-5D, FACT-G and FACT-BRM questionnaires were completed by patients during clinic visits. Data is presented graphically in attachment.

End point type

Secondary

End point timeframe

baseline, 3 months, 6, months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months

End point values	FAS
Number of subjects analysed
Units: percentage	812

Attachments

Untitled (Filename: Quality of Life data in figures.pdf)

No statistical analyses for this end point

Secondary: Overall survival

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End point title

Overall survival

End point description

Death from any cause was considered. Overall survival censored at 2 years (24 months) and 5 years (60 months) will be compared across treatments. Data is presented for 5 years and 2 years in attachment.

End point type

Secondary

End point timeframe

2 years and 5 years

End point values	Arm A	Arm B
Number of subjects analysed	406	406
Units: number of events (deaths)
0-12 months	5	5
12-24 months	11	9
24-36 months	19	14
36-48 months	27	25
48 to 60 months	34	31

Attachments

Untitled (Filename: Overall survival at 2 years.pdf)

No statistical analyses for this end point

Secondary: Tolerability between the regimens

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End point title

Tolerability between the regimens

End point description

The assessment of tolerability will consist of evaluating adverse events, laboratory parameters including haematology (haemaglobin, % blasts, WBC count, platelet count) and biochemistry (total bilirubin, LDH, AST, ALT, alkaline phosphatase, creatinine and urea), physical examinations and documentation of all concomitant medications and/or therapies including blood products. C'ardiovascular AEs include AEs with a preferred term of 'myocardial infarction', 'acute myocardial infarction', 'angina pectoris', 'coronary artery disease', 'acute coronary syndrome. Cytopenia AEs include AEs with a preferred term of 'anaemia', 'neutropenia' or 'thrombocytopenia'.

End point type

Secondary

End point timeframe

From start of study medication to 30 days after study medication stopped for each patient

End point values	Arm A	Arm B
Number of subjects analysed	406	406
Units: number of patients
Number of AEs	3801	4882
Number of patients with AEs	398	402
Number of SAEs	275	536
Number of patients with SAEs	140	233
Number of ADRs	1554	1861
Number of patients with ADRs	360	364
Number of serious ADRs	40	151
Number of patients with serious ADRs	33	105
Number of pleural effusion events	6	260
No. of patients with pleural effusion events	6	146
Number of pulmonary arterial hypertension events	0	1
No. of pts with PAH events	0	1
Number of dyspnoea events	41	141
Number of patients with dyspnoea events	38	100
Number of cardiovascular AEs	4	14
Number of patients with cardiovascular AEs	4	12
Number of cytopenia AEs	127	272
Number of patients with cytopenia AEs	76	129
Number of severe AEs	166	289
Number of patients with severe AEs	109	156
Number of AEs with tox grade 3 or 4	325	587
No. of patients with AEs of tox grade 3 or 4	185	253
Number of AEs leading to discontinuation	126	175
No. of pts with AEs leading to discontinuation	89	149
Number of AEs leading to death	22	18
Number of patients with AEs leading to death	20	18

Attachments

Uncoded AEs

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Occurring after starting study drug and up to 30 days after last dose

Adverse event reporting additional description

Adverse events (AEs) collected by physician, reported by patient or from laboratory tests. AEs were defined as any undesirable sign, symptom or medical condition whether considered study drug-related or not. If present before starting study drug, they are only considered AEs if they worsen after starting study drug.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Imatinib 400mg daily

Reporting group description

Imatinib 400mg daily

Reporting group title

Dasatinib 100mg daily

Reporting group description

Dasatinib 100mg daily

Serious adverse events	Imatinib 400mg daily	Dasatinib 100mg daily
Total subjects affected by serious adverse events
subjects affected / exposed	141 / 406 (34.73%)	234 / 406 (57.64%)
number of deaths (all causes)	34	31
number of deaths resulting from adverse events	20	18
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE LYMPHOCYTIC LEUKAEMIA
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
ACUTE MYELOID LEUKAEMIA
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 3
ADENOCARCINOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
B PRECURSOR TYPE ACUTE LEUKAEMIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
B-CELL LYMPHOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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	3 / 406 (0.74%)	5 / 406 (1.23%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
BLADDER TRANSITIONAL CELL CARCINOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BLAST CELL CRISIS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
BREAST CANCER
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
CHOLANGIOCARCINOMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
CHRONIC MYELOID LEUKAEMIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COLON CANCER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DIFFUSE LARGE B-CELL LYMPHOMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENDOMETRIAL CANCER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENDOMETRIAL CANCER METASTATIC
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
FOCAL NODULAR HYPERPLASIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GASTRIC CANCER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
INTRADUCTAL PROLIFERATIVE BREAST LESION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
KERATOACANTHOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
LYMPHOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
MALIGNANT NEOPLASM PROGRESSION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
MENINGIOMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MENINGIOMA MALIGNANT
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
METASTASES TO RECTUM
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
METASTASIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MYELODYSPLASTIC SYNDROME
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PARATHYROID TUMOUR BENIGN
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PLASMA CELL MYELOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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	4 / 406 (0.99%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RECTAL ADENOMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL CANCER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL ONCOCYTOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SQUAMOUS CELL CARCINOMA OF LUNG
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
TERATOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
UTERINE LEIOMYOMA
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
AORTIC ANEURYSM
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
AORTIC STENOSIS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ARTERIAL STENOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DEEP VEIN THROMBOSIS
subjects affected / exposed	4 / 406 (0.99%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 4	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMATOMA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMORRHAGE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (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	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOTENSION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
INTERMITTENT CLAUDICATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INTERNAL HAEMORRHAGE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LYMPHOEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL ARTERY OCCLUSION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL ISCHAEMIA
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
THROMBOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VASODILATATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
BREAST OPERATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHOLECYSTECTOMY
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HERNIA REPAIR
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HIP ARTHROPLASTY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
JOINT DEBRIDEMENT
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 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 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CATHETER SITE EXTRAVASATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CATHETER SITE HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHEST PAIN
subjects affected / exposed	2 / 406 (0.49%)	10 / 406 (2.46%)
occurrences causally related to treatment / all	0 / 2	2 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
DISEASE PROGRESSION
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	1 / 3	1 / 2
deaths causally related to treatment / all	0 / 2	0 / 0
GENERAL PHYSICAL HEALTH DETERIORATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GENERALISED OEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INFLUENZA LIKE ILLNESS
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
MUCOSAL ULCERATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
NON-CARDIAC CHEST PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OEDEMA PERIPHERAL
subjects affected / exposed	3 / 406 (0.74%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	3 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL SWELLING
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PYREXIA
subjects affected / exposed	3 / 406 (0.74%)	12 / 406 (2.96%)
occurrences causally related to treatment / all	1 / 3	6 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
ANAPHYLACTIC REACTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DRUG HYPERSENSITIVITY
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERSENSITIVITY
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
DYSMENORRHOEA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MENORRHAGIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OEDEMA GENITAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PRIAPISM
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TESTICULAR SWELLING
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
ASTHMA
subjects affected / exposed	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
subjects affected / exposed	2 / 406 (0.49%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
COUGH
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DYSPHONIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DYSPNOEA
subjects affected / exposed	3 / 406 (0.74%)	7 / 406 (1.72%)
occurrences causally related to treatment / all	0 / 3	3 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
EMPHYSEMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
EPISTAXIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMOPTYSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMOTHORAX
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOXIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OROPHARYNGEAL PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PLEURAL EFFUSION
subjects affected / exposed	1 / 406 (0.25%)	56 / 406 (13.79%)
occurrences causally related to treatment / all	0 / 1	61 / 65
deaths causally related to treatment / all	0 / 0	0 / 0
PLEURITIC PAIN
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY ARTERIAL HYPERTENSION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY CONGESTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY EMBOLISM
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY HYPERTENSION
subjects affected / exposed	0 / 406 (0.00%)	4 / 406 (0.99%)
occurrences causally related to treatment / all	0 / 0	4 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY OEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
CONFUSIONAL STATE
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
DEPRESSION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MAJOR DEPRESSION
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MENTAL DISORDER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PSYCHOTIC DISORDER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SUICIDE ATTEMPT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BLOOD CREATININE INCREASED
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BLOOD UREA INCREASED
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ELECTROCARDIOGRAM QT PROLONGED
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GAMMA-GLUTAMYLTRANSFERASE INCREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMOGLOBIN DECREASED
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LIVER FUNCTION TEST INCREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ANKLE FRACTURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CATARACT OPERATION COMPLICATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
FACIAL BONES FRACTURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
FALL
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
HUMERUS FRACTURE
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INJURY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INTENTIONAL OVERDOSE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
JOINT DISLOCATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
JOINT INJURY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LACERATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LUMBAR VERTEBRAL FRACTURE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OPEN FRACTURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL COMPLICATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL HAEMORRHAGE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RIB FRACTURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SOFT TISSUE INJURY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
STERNAL FRACTURE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SUBARACHNOID HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
SUBDURAL HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
SYNOVIAL RUPTURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TRANSFUSION REACTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ICHTHYOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
ACUTE CORONARY SYNDROME
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
ACUTE MYOCARDIAL INFARCTION
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
AGONAL RHYTHM
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
ANGINA PECTORIS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ARRHYTHMIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ATRIAL FIBRILLATION
subjects affected / exposed	7 / 406 (1.72%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	0 / 9	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
ATRIAL FLUTTER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ATRIOVENTRICULAR BLOCK
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ATRIOVENTRICULAR BLOCK FIRST DEGREE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BRADYCARDIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC ARREST
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
CARDIAC FAILURE
subjects affected / exposed	4 / 406 (0.99%)	4 / 406 (0.99%)
occurrences causally related to treatment / all	0 / 4	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 2
CARDIAC FAILURE CONGESTIVE
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	1 / 1	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC TAMPONADE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIOMEGALY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CORONARY ARTERY DISEASE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CYANOSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
LEFT VENTRICULAR FAILURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MYOCARDIAL INFARCTION
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
MYOCARDIAL ISCHAEMIA
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
PALPITATIONS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PERICARDIAL EFFUSION
subjects affected / exposed	0 / 406 (0.00%)	5 / 406 (1.23%)
occurrences causally related to treatment / all	0 / 0	5 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
PERICARDITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SUPRAVENTRICULAR TACHYCARDIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
AMNESIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BALANCE DISORDER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CENTRAL NERVOUS SYSTEM HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
CEREBELLAR HAEMORRHAGE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CEREBRAL INFARCTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CEREBROVASCULAR ACCIDENT
subjects affected / exposed	2 / 406 (0.49%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	0 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
DIZZINESS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
HEADACHE
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ISCHAEMIC STROKE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LACUNAR INFARCTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (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 / 406 (0.25%)	0 / 406 (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 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NEUROPATHY PERIPHERAL
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OPTIC NEURITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL SENSORY NEUROPATHY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PRESYNCOPE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SEIZURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SOMNOLENCE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SPEECH DISORDER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SYNCOPE
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TRANSIENT ISCHAEMIC ATTACK
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	2 / 406 (0.49%)	4 / 406 (0.99%)
occurrences causally related to treatment / all	2 / 2	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
CYTOPENIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LYMPHADENOPATHY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NEUTROPENIA
subjects affected / exposed	3 / 406 (0.74%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	3 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
THROMBOCYTOPENIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
THROMBOCYTOSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
MENIERE'S DISEASE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
MIDDLE EAR EFFUSION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VERTIGO POSITIONAL
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
CORNEAL PERFORATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
EYE OEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
EYE SWELLING
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MACULAR DEGENERATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIORBITAL OEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VITREOUS HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
ABDOMINAL HERNIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ABDOMINAL HERNIA OBSTRUCTIVE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ABDOMINAL PAIN
subjects affected / exposed	2 / 406 (0.49%)	6 / 406 (1.48%)
occurrences causally related to treatment / all	0 / 2	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
ABDOMINAL PAIN LOWER
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ANAL FISSURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ASCITES
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
BARRETT'S OESOPHAGUS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COLITIS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
CONSTIPATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CROHN'S DISEASE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DIARRHOEA
subjects affected / exposed	1 / 406 (0.25%)	9 / 406 (2.22%)
occurrences causally related to treatment / all	0 / 1	4 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
DIVERTICULUM
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DUODENAL STENOSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DYSPHAGIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENTEROCUTANEOUS FISTULA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
EPIGASTRIC DISCOMFORT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
EROSIVE DUODENITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GASTRIC MUCOSAL LESION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GASTRIC ULCER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROINTESTINAL HAEMORRHAGE
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
HAEMATEMESIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INTESTINAL OBSTRUCTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INTESTINAL PERFORATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LARGE INTESTINAL OBSTRUCTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LARGE INTESTINAL STENOSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LARGE INTESTINE PERFORATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
NAUSEA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PANCREATITIS ACUTE
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RECTAL HAEMORRHAGE
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SMALL INTESTINAL OBSTRUCTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VOMITING
subjects affected / exposed	2 / 406 (0.49%)	5 / 406 (1.23%)
occurrences causally related to treatment / all	1 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
BILIARY COLIC
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (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 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
GALLBLADDER PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HEPATIC CIRRHOSIS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Skin and subcutaneous tissue disorders
ANGIOEDEMA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ERYTHEMA MULTIFORME
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERSENSITIVITY VASCULITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIVASCULAR DERMATITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RASH
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RASH MACULAR
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SKIN REACTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SWELLING FACE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VASCULITIC RASH
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
ACUTE KIDNEY INJURY
subjects affected / exposed	2 / 406 (0.49%)	4 / 406 (0.99%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMATURIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	3 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
NEPHROLITHIASIS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NEPHROTIC SYNDROME
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POLLAKIURIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
URETHRAL DISORDER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
URETHRAL STENOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
HYPERTHYROIDISM
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
THYROID MASS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHRITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
BONE EROSION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BONE INFARCTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COSTOCHONDRITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
FRACTURE NONUNION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GROIN PAIN
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMARTHROSIS
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INTERVERTEBRAL DISC PROTRUSION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
MOBILITY DECREASED
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MUSCULOSKELETAL PAIN
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MYALGIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
NECK PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEITIS DEFORMANS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEOARTHRITIS
subjects affected / exposed	4 / 406 (0.99%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEONECROSIS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PAIN IN EXTREMITY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PERIARTHRITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ROTATOR CUFF SYNDROME
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SPINAL OSTEOARTHRITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SPINAL PAIN
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SYNOVITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
ABSCESS LIMB
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ANAL ABSCESS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
APPENDICITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHRITIS BACTERIAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
BACTERIAL DISEASE CARRIER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BACTERIAL INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BILIARY SEPSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CAMPYLOBACTER GASTROENTERITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CELLULITIS
subjects affected / exposed	4 / 406 (0.99%)	16 / 406 (3.94%)
occurrences causally related to treatment / all	1 / 4	3 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
CELLULITIS STREPTOCOCCAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CLOSTRIDIUM DIFFICILE INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COLONIC ABSCESS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CYSTITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DERMATITIS INFECTED
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DEVICE RELATED SEPSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DIVERTICULITIS
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ENDOCARDITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ERYSIPELAS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
FOLLICULITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
FUNGAL INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROENTERITIS
subjects affected / exposed	2 / 406 (0.49%)	8 / 406 (1.97%)
occurrences causally related to treatment / all	0 / 2	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROENTERITIS ASTROVIRAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROENTERITIS NOROVIRUS
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROENTERITIS VIRAL
subjects affected / exposed	0 / 406 (0.00%)	4 / 406 (0.99%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROINTESTINAL INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
H1N1 INFLUENZA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
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 / 406 (0.49%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTION
subjects affected / exposed	2 / 406 (0.49%)	4 / 406 (0.99%)
occurrences causally related to treatment / all	0 / 2	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
INFLUENZA
subjects affected / exposed	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
KIDNEY INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LOCALISED INFECTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LOWER RESPIRATORY TRACT INFECTION
subjects affected / exposed	8 / 406 (1.97%)	14 / 406 (3.45%)
occurrences causally related to treatment / all	0 / 8	2 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG INFECTION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NEUTROPENIC SEPSIS
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	3 / 3	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ORCHITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OTITIS EXTERNA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PAROTITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERINEAL INFECTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PERIORBITAL CELLULITIS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMOCYSTIS JIROVECII PNEUMONIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONIA
subjects affected / exposed	8 / 406 (1.97%)	15 / 406 (3.69%)
occurrences causally related to treatment / all	0 / 8	1 / 15
deaths causally related to treatment / all	0 / 3	0 / 1
PNEUMONIA PNEUMOCOCCAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL CELLULITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POSTOPERATIVE WOUND INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PYELONEPHRITIS ACUTE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RESPIRATORY SYNCYTIAL VIRUS INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RESPIRATORY TRACT INFECTION VIRAL
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SCARLET FEVER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SEPSIS
subjects affected / exposed	5 / 406 (1.23%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	1 / 5	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
STITCH ABSCESS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
STREPTOCOCCAL INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SUBCUTANEOUS ABSCESS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TUBERCULOSIS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
URINARY TRACT INFECTION
subjects affected / exposed	2 / 406 (0.49%)	5 / 406 (1.23%)
occurrences causally related to treatment / all	0 / 2	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
UROSEPSIS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
VIRAL INFECTION
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
VIRAL SEPSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIRAL TONSILLITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
WOUND INFECTION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
DEHYDRATION
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
FLUID RETENTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GOUT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERGLYCAEMIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERKALAEMIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERNATRAEMIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOGLYCAEMIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOKALAEMIA
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYPONATRAEMIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	Imatinib 400mg daily	Dasatinib 100mg daily
Total subjects affected by non serious adverse events
subjects affected / exposed	394 / 406 (97.04%)	392 / 406 (96.55%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADRENAL ADENOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
B-CELL LYMPHOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BASAL CELL CARCINOMA
subjects affected / exposed	4 / 406 (0.99%)	1 / 406 (0.25%)
occurrences all number	8	1
BENIGN BREAST NEOPLASM
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BENIGN NEOPLASM
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
FIBROADENOMA OF BREAST
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
LIPOMA
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	2
MELANOCYTIC NAEVUS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PROSTATE CANCER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SARCOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SCHWANNOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SKIN PAPILLOMA
subjects affected / exposed	3 / 406 (0.74%)	1 / 406 (0.25%)
occurrences all number	4	1
UTERINE LEIOMYOMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
Vascular disorders
ANGIODYSPLASIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
FLUSHING
subjects affected / exposed	3 / 406 (0.74%)	9 / 406 (2.22%)
occurrences all number	3	9
HAEMATOMA
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	3
HOT FLUSH
subjects affected / exposed	7 / 406 (1.72%)	14 / 406 (3.45%)
occurrences all number	7	14
HYPERTENSION
subjects affected / exposed	5 / 406 (1.23%)	12 / 406 (2.96%)
occurrences all number	5	13
HYPOTENSION
subjects affected / exposed	4 / 406 (0.99%)	1 / 406 (0.25%)
occurrences all number	4	1
LYMPHOEDEMA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
ORTHOSTATIC HYPOTENSION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
PERIPHERAL COLDNESS
subjects affected / exposed	3 / 406 (0.74%)	6 / 406 (1.48%)
occurrences all number	3	6
PERIPHERAL ISCHAEMIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PHLEBITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
RAYNAUD'S PHENOMENON
subjects affected / exposed	2 / 406 (0.49%)	3 / 406 (0.74%)
occurrences all number	2	3
THROMBOPHLEBITIS
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences all number	1	3
THROMBOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	2
VARICOSE VEIN
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
Surgical and medical procedures
ABSCESS DRAINAGE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ANOPLASTY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CANCER SURGERY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CATARACT OPERATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CIRCUMCISION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
FINGER REPAIR OPERATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
INGUINAL HERNIA REPAIR
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
KNEE ARTHROPLASTY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
LIPOMA EXCISION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
MANIPULATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
MOLE EXCISION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
NASAL SEPTAL OPERATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SALPINGO-OOPHORECTOMY BILATERAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SKIN NEOPLASM EXCISION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
TONSILLECTOMY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
TOOTH EXTRACTION
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
UMBILICAL HERNIA REPAIR
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
UVULECTOMY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
General disorders and administration site conditions
ADVERSE DRUG REACTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ASTHENIA
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
AXILLARY PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CHEST DISCOMFORT
subjects affected / exposed	5 / 406 (1.23%)	7 / 406 (1.72%)
occurrences all number	5	7
CHEST PAIN
subjects affected / exposed	12 / 406 (2.96%)	24 / 406 (5.91%)
occurrences all number	13	27
CHILLS
subjects affected / exposed	5 / 406 (1.23%)	8 / 406 (1.97%)
occurrences all number	5	8
CYST
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
DISCOMFORT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
FACE OEDEMA
subjects affected / exposed	7 / 406 (1.72%)	5 / 406 (1.23%)
occurrences all number	7	5
FATIGUE
subjects affected / exposed	123 / 406 (30.30%)	147 / 406 (36.21%)
occurrences all number	146	196
FEELING ABNORMAL
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
FEELING COLD
subjects affected / exposed	4 / 406 (0.99%)	8 / 406 (1.97%)
occurrences all number	4	8
FEELING HOT
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
GENERALISED OEDEMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
GRANULOMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
HERNIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
HERNIA PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HUNGER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
INFLUENZA LIKE ILLNESS
subjects affected / exposed	14 / 406 (3.45%)	17 / 406 (4.19%)
occurrences all number	20	18
LOCAL SWELLING
subjects affected / exposed	1 / 406 (0.25%)	6 / 406 (1.48%)
occurrences all number	1	8
LOCALISED OEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
MALAISE
subjects affected / exposed	6 / 406 (1.48%)	10 / 406 (2.46%)
occurrences all number	6	11
MASS
subjects affected / exposed	1 / 406 (0.25%)	6 / 406 (1.48%)
occurrences all number	1	7
MUCOSAL INFLAMMATION
subjects affected / exposed	3 / 406 (0.74%)	3 / 406 (0.74%)
occurrences all number	3	3
NODULE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
NON-CARDIAC CHEST PAIN
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
OEDEMA
subjects affected / exposed	8 / 406 (1.97%)	5 / 406 (1.23%)
occurrences all number	8	5
OEDEMA PERIPHERAL
subjects affected / exposed	31 / 406 (7.64%)	17 / 406 (4.19%)
occurrences all number	40	22
PAIN
subjects affected / exposed	18 / 406 (4.43%)	16 / 406 (3.94%)
occurrences all number	20	16
PERIPHERAL SWELLING
subjects affected / exposed	14 / 406 (3.45%)	6 / 406 (1.48%)
occurrences all number	16	7
POLYP
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PYREXIA
subjects affected / exposed	9 / 406 (2.22%)	18 / 406 (4.43%)
occurrences all number	10	22
SENSATION OF BLOOD FLOW
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SUPRAPUBIC PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SWELLING
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
TEMPERATURE INTOLERANCE
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	2
TENDERNESS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
THIRST
subjects affected / exposed	3 / 406 (0.74%)	1 / 406 (0.25%)
occurrences all number	3	1
ULCER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Immune system disorders
DRUG HYPERSENSITIVITY
subjects affected / exposed	2 / 406 (0.49%)	6 / 406 (1.48%)
occurrences all number	2	6
HYPERSENSITIVITY
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
HYPOGAMMAGLOBULINAEMIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SEASONAL ALLERGY
subjects affected / exposed	2 / 406 (0.49%)	10 / 406 (2.46%)
occurrences all number	2	10
Social circumstances
MENOPAUSE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BREAST DISCHARGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BREAST MASS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	2
BREAST OEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BREAST PAIN
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
BREAST SWELLING
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BREAST TENDERNESS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
CERVICAL DYSPLASIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
DYSMENORRHOEA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	2	0
ENDOMETRIOSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ERECTILE DYSFUNCTION
subjects affected / exposed	5 / 406 (1.23%)	2 / 406 (0.49%)
occurrences all number	6	2
GENITAL PAIN
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
GYNAECOMASTIA
subjects affected / exposed	2 / 406 (0.49%)	5 / 406 (1.23%)
occurrences all number	2	6
MENORRHAGIA
subjects affected / exposed	5 / 406 (1.23%)	7 / 406 (1.72%)
occurrences all number	6	8
MENSTRUATION IRREGULAR
subjects affected / exposed	4 / 406 (0.99%)	3 / 406 (0.74%)
occurrences all number	4	3
METRORRHAGIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
NIPPLE PAIN
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
OEDEMA GENITAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
OVARIAN CYST
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PELVIC PAIN
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
PENILE PAIN
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
PENILE SWELLING
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PERINEAL PAIN
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
POLYMENORRHOEA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PRIAPISM
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PROSTATITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PROSTATOMEGALY
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
SCROTAL OEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
TESTICULAR PAIN
subjects affected / exposed	1 / 406 (0.25%)	5 / 406 (1.23%)
occurrences all number	1	5
TESTICULAR SWELLING
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
VAGINAL CYST
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
VAGINAL DISCHARGE
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
VAGINAL HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	7 / 406 (1.72%)
occurrences all number	0	8
Respiratory, thoracic and mediastinal disorders
ASTHMA
subjects affected / exposed	2 / 406 (0.49%)	3 / 406 (0.74%)
occurrences all number	2	4
ATELECTASIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BRONCHOSPASM
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CATARRH
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
subjects affected / exposed	2 / 406 (0.49%)	3 / 406 (0.74%)
occurrences all number	2	3
COUGH
subjects affected / exposed	30 / 406 (7.39%)	60 / 406 (14.78%)
occurrences all number	32	70
DIAPHRAGMALGIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
DRY THROAT
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
DYSPHONIA
subjects affected / exposed	3 / 406 (0.74%)	4 / 406 (0.99%)
occurrences all number	3	4
DYSPNOEA
subjects affected / exposed	35 / 406 (8.62%)	99 / 406 (24.38%)
occurrences all number	38	134
DYSPNOEA AT REST
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
DYSPNOEA EXERTIONAL
subjects affected / exposed	12 / 406 (2.96%)	22 / 406 (5.42%)
occurrences all number	12	25
DYSPNOEA PAROXYSMAL NOCTURNAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
EPISTAXIS
subjects affected / exposed	10 / 406 (2.46%)	8 / 406 (1.97%)
occurrences all number	13	8
HAEMOPTYSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
HICCUPS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
HYPOXIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
INTERSTITIAL LUNG DISEASE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
LARYNGEAL INFLAMMATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
LARYNGEAL POLYP
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
LUNG CONSOLIDATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
NASAL CONGESTION
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences all number	5	2
OROPHARYNGEAL PAIN
subjects affected / exposed	18 / 406 (4.43%)	28 / 406 (6.90%)
occurrences all number	20	30
ORTHOPNOEA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PHARYNGEAL LEUKOPLAKIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PHARYNGEAL OEDEMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PLEURAL EFFUSION
subjects affected / exposed	4 / 406 (0.99%)	108 / 406 (26.60%)
occurrences all number	4	193
PLEURISY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PLEURITIC PAIN
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences all number	3	2
PNEUMONITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PRODUCTIVE COUGH
subjects affected / exposed	4 / 406 (0.99%)	13 / 406 (3.20%)
occurrences all number	5	13
PULMONARY CONGESTION
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
PULMONARY EMBOLISM
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PULMONARY FIBROSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PULMONARY HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PULMONARY HYPERTENSION
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
PULMONARY OEDEMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PULMONARY SARCOIDOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
RHINITIS ALLERGIC
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
RHINORRHOEA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
SINUS CONGESTION
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
SINUS PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SLEEP APNOEA SYNDROME
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
THROAT IRRITATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
VOCAL CORD CYST
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
WHEEZING
subjects affected / exposed	1 / 406 (0.25%)	7 / 406 (1.72%)
occurrences all number	1	7
Psychiatric disorders
ABNORMAL DREAMS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
AFFECT LABILITY
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
AFFECTIVE DISORDER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
AGGRESSION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
AGITATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ANXIETY
subjects affected / exposed	7 / 406 (1.72%)	13 / 406 (3.20%)
occurrences all number	7	17
CONFUSIONAL STATE
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
DEPRESSED MOOD
subjects affected / exposed	7 / 406 (1.72%)	18 / 406 (4.43%)
occurrences all number	7	19
DEPRESSION
subjects affected / exposed	16 / 406 (3.94%)	30 / 406 (7.39%)
occurrences all number	16	30
DEPRESSIVE SYMPTOM
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
EATING DISORDER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
HALLUCINATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	2	0
INSOMNIA
subjects affected / exposed	25 / 406 (6.16%)	23 / 406 (5.67%)
occurrences all number	26	25
IRRITABILITY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
LIBIDO DECREASED
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
LOSS OF LIBIDO
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
MENTAL DISORDER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
MOOD ALTERED
subjects affected / exposed	4 / 406 (0.99%)	7 / 406 (1.72%)
occurrences all number	4	7
MOOD SWINGS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PANIC ATTACK
subjects affected / exposed	0 / 406 (0.00%)	4 / 406 (0.99%)
occurrences all number	0	4
PERSONALITY DISORDER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PSYCHIATRIC SYMPTOM
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
SCHIZOPHRENIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SLEEP DISORDER
subjects affected / exposed	6 / 406 (1.48%)	3 / 406 (0.74%)
occurrences all number	6	3
STRESS
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
SUICIDE ATTEMPT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Product issues
DEVICE DAMAGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Hepatobiliary disorders
CHOLELITHIASIS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
GALLBLADDER PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HEPATIC CIRRHOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HEPATIC FUNCTION ABNORMAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HEPATIC STEATOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Investigations
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	7 / 406 (1.72%)	5 / 406 (1.23%)
occurrences all number	8	10
ASPARTATE AMINOTRANSFERASE INCREASED
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	5
BIOPSY PROSTATE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BLOOD ALKALINE PHOSPHATASE INCREASED
subjects affected / exposed	5 / 406 (1.23%)	0 / 406 (0.00%)
occurrences all number	5	0
BLOOD BILIRUBIN INCREASED
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	2
BLOOD CALCIUM DECREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BLOOD CHOLESTEROL INCREASED
subjects affected / exposed	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences all number	1	4
BLOOD COUNT ABNORMAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BLOOD CREATINE PHOSPHOKINASE INCREASED
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
BLOOD CREATININE INCREASED
subjects affected / exposed	3 / 406 (0.74%)	3 / 406 (0.74%)
occurrences all number	3	3
BLOOD FOLATE DECREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BLOOD GLUCOSE INCREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BLOOD IRON DECREASED
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BLOOD LACTATE DEHYDROGENASE INCREASED
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BLOOD PHOSPHORUS DECREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BLOOD POTASSIUM DECREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BLOOD PRESSURE INCREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BLOOD THYROID STIMULATING HORMONE INCREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BORRELIA TEST
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CARDIAC MURMUR
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
CLOSTRIDIUM TEST POSITIVE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
COLONOSCOPY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ECHOCARDIOGRAM ABNORMAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ELECTROCARDIOGRAM PR SHORTENED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ENDOSCOPY UPPER GASTROINTESTINAL TRACT
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
GAMMA-GLUTAMYLTRANSFERASE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
GAMMA-GLUTAMYLTRANSFERASE INCREASED
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
HAEMOGLOBIN DECREASED
subjects affected / exposed	3 / 406 (0.74%)	8 / 406 (1.97%)
occurrences all number	3	9
INTRAOCULAR PRESSURE INCREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
LIVER FUNCTION TEST ABNORMAL
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
MENSTRUATION NORMAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
NEUTROPHIL COUNT
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	2	2
NEUTROPHIL COUNT DECREASED
subjects affected / exposed	4 / 406 (0.99%)	7 / 406 (1.72%)
occurrences all number	5	10
PLATELET COUNT DECREASED
subjects affected / exposed	7 / 406 (1.72%)	11 / 406 (2.71%)
occurrences all number	9	20
PROSTATIC SPECIFIC ANTIGEN INCREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PROTEIN URINE PRESENT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SERUM FERRITIN DECREASED
subjects affected / exposed	0 / 406 (0.00%)	7 / 406 (1.72%)
occurrences all number	0	8
STREPTOCOCCUS TEST POSITIVE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
THYROID FUNCTION TEST ABNORMAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
VITAMIN B12 DECREASED
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
VITAMIN D DECREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
WEIGHT DECREASED
subjects affected / exposed	7 / 406 (1.72%)	15 / 406 (3.69%)
occurrences all number	8	15
WEIGHT INCREASED
subjects affected / exposed	15 / 406 (3.69%)	7 / 406 (1.72%)
occurrences all number	15	12
WHITE BLOOD CELL COUNT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	2
WHITE BLOOD CELL COUNT DECREASED
subjects affected / exposed	2 / 406 (0.49%)	4 / 406 (0.99%)
occurrences all number	2	4
WHITE BLOOD CELL COUNT INCREASED
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ANKLE FRACTURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ARTHROPOD BITE
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
AVULSION FRACTURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CHEST INJURY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CLAVICLE FRACTURE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CONTUSION
subjects affected / exposed	8 / 406 (1.97%)	9 / 406 (2.22%)
occurrences all number	8	9
DENTAL RESTORATION FAILURE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
EPICONDYLITIS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
EYE CONTUSION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
FALL
subjects affected / exposed	8 / 406 (1.97%)	11 / 406 (2.71%)
occurrences all number	9	14
FOOT FRACTURE
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
FRACTURE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
GASTROINTESTINAL STOMA COMPLICATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
HEAD INJURY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
INJURY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
JOINT DISLOCATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
JOINT INJURY
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
LACERATION
subjects affected / exposed	6 / 406 (1.48%)	0 / 406 (0.00%)
occurrences all number	6	0
LIGAMENT RUPTURE
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
LIGAMENT SPRAIN
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
LIMB INJURY
subjects affected / exposed	2 / 406 (0.49%)	3 / 406 (0.74%)
occurrences all number	2	3
MEDICATION ERROR
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
MENISCUS INJURY
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
MUSCLE STRAIN
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	2
NECK INJURY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
POST PROCEDURAL DISCOMFORT
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
POST PROCEDURAL HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
POST-TRAUMATIC NECK SYNDROME
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PROCEDURAL DIZZINESS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PROCEDURAL PAIN
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
RIB FRACTURE
subjects affected / exposed	3 / 406 (0.74%)	1 / 406 (0.25%)
occurrences all number	3	1
SOFT TISSUE INJURY
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
SUNBURN
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
TENDON RUPTURE
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
THERMAL BURN
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	3	0
UPPER LIMB FRACTURE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	2	0
VACCINATION COMPLICATION
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
WRIST FRACTURE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	2	0
Congenital, familial and genetic disorders
GILBERT'S SYNDROME
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HYDROCELE
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences all number	3	2
PHIMOSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
Cardiac disorders
ANGINA PECTORIS
subjects affected / exposed	0 / 406 (0.00%)	4 / 406 (0.99%)
occurrences all number	0	4
ARRHYTHMIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ATRIAL FIBRILLATION
subjects affected / exposed	3 / 406 (0.74%)	6 / 406 (1.48%)
occurrences all number	3	7
BRADYCARDIA
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
BUNDLE BRANCH BLOCK RIGHT
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CARDIAC FAILURE CHRONIC
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CARDIAC VALVE DISEASE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CARDIOMEGALY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CARDIOMYOPATHY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CARDIOTOXICITY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CONDUCTION DISORDER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
DIASTOLIC DYSFUNCTION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
LEFT VENTRICULAR DYSFUNCTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
LEFT VENTRICULAR FAILURE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
LEFT VENTRICULAR HYPERTROPHY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
MITRAL VALVE INCOMPETENCE
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
MYOCARDIAL ISCHAEMIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
PALPITATIONS
subjects affected / exposed	9 / 406 (2.22%)	17 / 406 (4.19%)
occurrences all number	11	19
PERICARDIAL EFFUSION
subjects affected / exposed	1 / 406 (0.25%)	7 / 406 (1.72%)
occurrences all number	1	7
PERICARDITIS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	2
SUPRAVENTRICULAR EXTRASYSTOLES
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
TACHYCARDIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
Nervous system disorders
AGEUSIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
AMNESIA
subjects affected / exposed	2 / 406 (0.49%)	5 / 406 (1.23%)
occurrences all number	2	5
BALANCE DISORDER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BURNING SENSATION
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
CAROTID ARTERY CALCIFICATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CARPAL TUNNEL SYNDROME
subjects affected / exposed	0 / 406 (0.00%)	5 / 406 (1.23%)
occurrences all number	0	6
CEREBELLAR INFARCTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CLUSTER HEADACHE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
COGNITIVE DISORDER
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
DEMENTIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	2
DISTURBANCE IN ATTENTION
subjects affected / exposed	4 / 406 (0.99%)	2 / 406 (0.49%)
occurrences all number	4	2
DIZZINESS
subjects affected / exposed	29 / 406 (7.14%)	36 / 406 (8.87%)
occurrences all number	31	45
DIZZINESS POSTURAL
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
DYSGEUSIA
subjects affected / exposed	13 / 406 (3.20%)	9 / 406 (2.22%)
occurrences all number	13	9
DYSKINESIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
DYSTONIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
EXERTIONAL HEADACHE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
FACIAL PARALYSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HEADACHE
subjects affected / exposed	61 / 406 (15.02%)	110 / 406 (27.09%)
occurrences all number	75	140
HYPERAESTHESIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
HYPOAESTHESIA
subjects affected / exposed	11 / 406 (2.71%)	8 / 406 (1.97%)
occurrences all number	12	9
LETHARGY
subjects affected / exposed	39 / 406 (9.61%)	34 / 406 (8.37%)
occurrences all number	42	37
LOSS OF CONSCIOUSNESS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
MEMORY IMPAIRMENT
subjects affected / exposed	3 / 406 (0.74%)	8 / 406 (1.97%)
occurrences all number	4	8
MENTAL IMPAIRMENT
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
MIGRAINE
subjects affected / exposed	6 / 406 (1.48%)	3 / 406 (0.74%)
occurrences all number	6	3
NERVE COMPRESSION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
NEURALGIA
subjects affected / exposed	5 / 406 (1.23%)	3 / 406 (0.74%)
occurrences all number	5	3
NEUROLOGICAL SYMPTOM
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
NEUROPATHY PERIPHERAL
subjects affected / exposed	8 / 406 (1.97%)	5 / 406 (1.23%)
occurrences all number	9	5
PARAESTHESIA
subjects affected / exposed	12 / 406 (2.96%)	15 / 406 (3.69%)
occurrences all number	14	16
PERIPHERAL MOTOR NEUROPATHY
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
PERIPHERAL SENSORY NEUROPATHY
subjects affected / exposed	3 / 406 (0.74%)	8 / 406 (1.97%)
occurrences all number	3	8
POOR QUALITY SLEEP
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
POST HERPETIC NEURALGIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PRESYNCOPE
subjects affected / exposed	3 / 406 (0.74%)	0 / 406 (0.00%)
occurrences all number	3	0
RESTLESS LEGS SYNDROME
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
SCIATICA
subjects affected / exposed	4 / 406 (0.99%)	7 / 406 (1.72%)
occurrences all number	5	8
SEIZURE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SENSORY DISTURBANCE
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
SOMNOLENCE
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	3	1
SPEECH DISORDER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SYNCOPE
subjects affected / exposed	5 / 406 (1.23%)	4 / 406 (0.99%)
occurrences all number	5	4
TRANSIENT ISCHAEMIC ATTACK
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	3	1
TREMOR
subjects affected / exposed	1 / 406 (0.25%)	6 / 406 (1.48%)
occurrences all number	1	7
VASCULAR DEMENTIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
VISUAL FIELD DEFECT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	27 / 406 (6.65%)	40 / 406 (9.85%)
occurrences all number	34	66
BICYTOPENIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BONE MARROW FAILURE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
COAGULOPATHY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CYTOPENIA
subjects affected / exposed	4 / 406 (0.99%)	4 / 406 (0.99%)
occurrences all number	4	4
HAEMATOTOXICITY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
INCREASED TENDENCY TO BRUISE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
IRON DEFICIENCY ANAEMIA
subjects affected / exposed	4 / 406 (0.99%)	3 / 406 (0.74%)
occurrences all number	4	3
LEUKOCYTOSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
LEUKOPENIA
subjects affected / exposed	3 / 406 (0.74%)	3 / 406 (0.74%)
occurrences all number	3	3
LYMPHADENITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
LYMPHADENOPATHY
subjects affected / exposed	1 / 406 (0.25%)	9 / 406 (2.22%)
occurrences all number	1	9
LYMPHOCYTOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
NEUTROPENIA
subjects affected / exposed	37 / 406 (9.11%)	49 / 406 (12.07%)
occurrences all number	60	94
NEUTROPHILIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PANCYTOPENIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
POLYCYTHAEMIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SPLENIC INFARCTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SPLENOMEGALY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
THROMBOCYTOPENIA
subjects affected / exposed	23 / 406 (5.67%)	65 / 406 (16.01%)
occurrences all number	28	106
THROMBOCYTOPENIC PURPURA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
THROMBOCYTOSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
Ear and labyrinth disorders
DEAFNESS
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
DEAFNESS UNILATERAL
subjects affected / exposed	3 / 406 (0.74%)	1 / 406 (0.25%)
occurrences all number	3	1
EAR CONGESTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
EAR DISCOMFORT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
EAR HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
EAR PAIN
subjects affected / exposed	5 / 406 (1.23%)	5 / 406 (1.23%)
occurrences all number	5	5
EXCESSIVE CERUMEN PRODUCTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
EXTERNAL EAR PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HYPERACUSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
HYPOACUSIS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
MENIERE'S DISEASE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
MIDDLE EAR DISORDER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
OTORRHOEA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
TINNITUS
subjects affected / exposed	4 / 406 (0.99%)	8 / 406 (1.97%)
occurrences all number	4	8
TYMPANIC MEMBRANE PERFORATION
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
VERTIGO
subjects affected / exposed	3 / 406 (0.74%)	7 / 406 (1.72%)
occurrences all number	3	8
VERTIGO POSITIONAL
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
Eye disorders
ANGLE CLOSURE GLAUCOMA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ASTHENOPIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	2	1
BLEPHARAL PIGMENTATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BLEPHARITIS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
BLEPHAROSPASM
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
BLINDNESS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CATARACT
subjects affected / exposed	2 / 406 (0.49%)	4 / 406 (0.99%)
occurrences all number	2	4
CATARACT NUCLEAR
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CONJUNCTIVAL HAEMORRHAGE
subjects affected / exposed	8 / 406 (1.97%)	1 / 406 (0.25%)
occurrences all number	8	1
CONJUNCTIVITIS ALLERGIC
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
DIABETIC RETINOPATHY
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
DIPLOPIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
DRY AGE-RELATED MACULAR DEGENERATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
DRY EYE
subjects affected / exposed	10 / 406 (2.46%)	7 / 406 (1.72%)
occurrences all number	11	7
ERYTHEMA OF EYELID
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
EYE ALLERGY
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
EYE DISCHARGE
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	3
EYE HAEMORRHAGE
subjects affected / exposed	4 / 406 (0.99%)	1 / 406 (0.25%)
occurrences all number	5	1
EYE INFLAMMATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
EYE OEDEMA
subjects affected / exposed	13 / 406 (3.20%)	3 / 406 (0.74%)
occurrences all number	15	3
EYE PAIN
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences all number	3	2
EYE PRURITUS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
EYE SWELLING
subjects affected / exposed	36 / 406 (8.87%)	8 / 406 (1.97%)
occurrences all number	40	10
EYE ULCER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
EYELID OEDEMA
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	3	1
GLAUCOMA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
IRITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
KERATOCONUS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
LACRIMATION INCREASED
subjects affected / exposed	15 / 406 (3.69%)	4 / 406 (0.99%)
occurrences all number	15	4
MACULAR DEGENERATION
subjects affected / exposed	3 / 406 (0.74%)	0 / 406 (0.00%)
occurrences all number	3	0
MACULAR FIBROSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
MACULAR OEDEMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
OCULAR HYPERAEMIA
subjects affected / exposed	7 / 406 (1.72%)	7 / 406 (1.72%)
occurrences all number	11	7
OCULAR HYPERTENSION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ORBITAL OEDEMA
subjects affected / exposed	5 / 406 (1.23%)	0 / 406 (0.00%)
occurrences all number	5	0
PERIORBITAL OEDEMA
subjects affected / exposed	50 / 406 (12.32%)	22 / 406 (5.42%)
occurrences all number	58	28
PHOTOPHOBIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PHOTOPSIA
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
RETINAL DETACHMENT
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
RETINAL HAEMORRHAGE
subjects affected / exposed	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences all number	1	4
RETINOPATHY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
RETINOPATHY HYPERTENSIVE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SCLERAL HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SWOLLEN TEAR DUCT
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
VISION BLURRED
subjects affected / exposed	11 / 406 (2.71%)	11 / 406 (2.71%)
occurrences all number	13	13
VISUAL IMPAIRMENT
subjects affected / exposed	4 / 406 (0.99%)	5 / 406 (1.23%)
occurrences all number	4	7
VITREOUS FLOATERS
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
VITREOUS HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
subjects affected / exposed	14 / 406 (3.45%)	13 / 406 (3.20%)
occurrences all number	17	13
ABDOMINAL DISTENSION
subjects affected / exposed	10 / 406 (2.46%)	11 / 406 (2.71%)
occurrences all number	11	13
ABDOMINAL HERNIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ABDOMINAL PAIN
subjects affected / exposed	40 / 406 (9.85%)	39 / 406 (9.61%)
occurrences all number	42	45
ABDOMINAL PAIN UPPER
subjects affected / exposed	15 / 406 (3.69%)	17 / 406 (4.19%)
occurrences all number	16	18
ABDOMINAL PAIN LOWER
subjects affected / exposed	4 / 406 (0.99%)	4 / 406 (0.99%)
occurrences all number	4	4
ABDOMINAL TENDERNESS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
ANAL FISSURE
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences all number	1	3
ANAL FISTULA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ANAL INCONTINENCE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ANAL POLYP
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ANORECTAL DISCOMFORT
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ASCITES
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BOWEL MOVEMENT IRREGULARITY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BUCCAL MUCOSAL ROUGHENING
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CHANGE OF BOWEL HABIT
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
COLITIS
subjects affected / exposed	0 / 406 (0.00%)	4 / 406 (0.99%)
occurrences all number	0	4
CROHN'S DISEASE
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	2	1
CONSTIPATION
subjects affected / exposed	22 / 406 (5.42%)	54 / 406 (13.30%)
occurrences all number	24	64
DENTAL CARIES
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
DIARRHOEA
subjects affected / exposed	151 / 406 (37.19%)	112 / 406 (27.59%)
occurrences all number	204	160
DIVERTICULUM
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
DRY MOUTH
subjects affected / exposed	4 / 406 (0.99%)	2 / 406 (0.49%)
occurrences all number	4	2
DUODENAL ULCER
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
DYSPEPSIA
subjects affected / exposed	35 / 406 (8.62%)	20 / 406 (4.93%)
occurrences all number	43	24
DYSPHAGIA
subjects affected / exposed	2 / 406 (0.49%)	5 / 406 (1.23%)
occurrences all number	2	5
EPIGASTRIC DISCOMFORT
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
FAECES DISCOLOURED
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
FAECES SOFT
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
FLATULENCE
subjects affected / exposed	9 / 406 (2.22%)	9 / 406 (2.22%)
occurrences all number	10	9
FOOD POISONING
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences all number	3	2
FREQUENT BOWEL MOVEMENTS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
GASTRIC ANTRAL VASCULAR ECTASIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
GASTRIC ULCER
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
GASTRITIS
subjects affected / exposed	2 / 406 (0.49%)	5 / 406 (1.23%)
occurrences all number	2	5
GASTRITIS EROSIVE
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
GASTRITIS HAEMORRHAGIC
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
GASTROINTESTINAL DISORDER
subjects affected / exposed	5 / 406 (1.23%)	1 / 406 (0.25%)
occurrences all number	5	1
GASTROINTESTINAL HAEMORRHAGE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
GASTROINTESTINAL INFLAMMATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
GASTROOESOPHAGEAL REFLUX DISEASE
subjects affected / exposed	7 / 406 (1.72%)	5 / 406 (1.23%)
occurrences all number	8	5
GINGIVAL BLEEDING
subjects affected / exposed	4 / 406 (0.99%)	2 / 406 (0.49%)
occurrences all number	4	2
GINGIVAL PAIN
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
GLOSSODYNIA
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
HAEMATEMESIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HAEMATOCHEZIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
HAEMORRHOIDAL HAEMORRHAGE
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
HAEMORRHOIDS
subjects affected / exposed	4 / 406 (0.99%)	7 / 406 (1.72%)
occurrences all number	4	8
HIATUS HERNIA
subjects affected / exposed	4 / 406 (0.99%)	2 / 406 (0.49%)
occurrences all number	4	2
HYPERCHLORHYDRIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ILEUS PARALYTIC
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
IRRITABLE BOWEL SYNDROME
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
LARGE INTESTINE POLYP
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
LIP DRY
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
LIP PAIN
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
LIP SWELLING
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
MELAENA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
MOUTH CYST
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
MOUTH HAEMORRHAGE
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
MOUTH ULCERATION
subjects affected / exposed	17 / 406 (4.19%)	27 / 406 (6.65%)
occurrences all number	17	40
NAUSEA
subjects affected / exposed	146 / 406 (35.96%)	108 / 406 (26.60%)
occurrences all number	180	125
ODYNOPHAGIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
OESOPHAGITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ORAL MUCOSAL BLISTERING
subjects affected / exposed	3 / 406 (0.74%)	0 / 406 (0.00%)
occurrences all number	3	0
ORAL PAIN
subjects affected / exposed	0 / 406 (0.00%)	4 / 406 (0.99%)
occurrences all number	0	4
PAROTID GLAND ENLARGEMENT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
POUCHITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PROCTALGIA
subjects affected / exposed	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences all number	1	4
RECTAL DISCHARGE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
RECTAL HAEMORRHAGE
subjects affected / exposed	9 / 406 (2.22%)	7 / 406 (1.72%)
occurrences all number	9	7
RECTAL POLYP
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	5	1
REFLUX GASTRITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
RETCHING
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SPLENIC ARTERY ANEURYSM
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
STOMATITIS
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences all number	1	3
SWOLLEN TONGUE
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
TONGUE BLISTERING
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
TONGUE COATED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
TONGUE OEDEMA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
TONGUE ULCERATION
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	3	0
TOOTH DISORDER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
TOOTH EROSION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
TOOTH IMPACTED
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
TOOTH LOSS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
TOOTHACHE
subjects affected / exposed	3 / 406 (0.74%)	7 / 406 (1.72%)
occurrences all number	3	8
VOMITING
subjects affected / exposed	67 / 406 (16.50%)	53 / 406 (13.05%)
occurrences all number	81	64
UMBILICAL HERNIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders
ACNE
subjects affected / exposed	0 / 406 (0.00%)	12 / 406 (2.96%)
occurrences all number	0	13
ACTINIC KERATOSIS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
ALOPECIA
subjects affected / exposed	22 / 406 (5.42%)	21 / 406 (5.17%)
occurrences all number	23	21
BLISTER
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences all number	3	2
BLOOD BLISTER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
COLD SWEAT
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
DERMAL CYST
subjects affected / exposed	4 / 406 (0.99%)	1 / 406 (0.25%)
occurrences all number	4	1
DERMATITIS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
DERMATITIS ACNEIFORM
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	3
DERMATITIS ALLERGIC
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
DERMATITIS CONTACT
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
DERMATOSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
DIABETIC FOOT
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
DRY SKIN
subjects affected / exposed	21 / 406 (5.17%)	21 / 406 (5.17%)
occurrences all number	22	24
ECZEMA
subjects affected / exposed	7 / 406 (1.72%)	8 / 406 (1.97%)
occurrences all number	8	8
ERYTHEMA
subjects affected / exposed	5 / 406 (1.23%)	7 / 406 (1.72%)
occurrences all number	6	7
ERYTHEMA NODOSUM
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
EXCESSIVE SKIN
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
EXFOLIATIVE RASH
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
FORDYCE SPOTS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HAIR COLOUR CHANGES
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HAIR GROWTH ABNORMAL
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
HAND DERMATITIS
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
HYPERHIDROSIS
subjects affected / exposed	6 / 406 (1.48%)	13 / 406 (3.20%)
occurrences all number	6	13
HYPERKERATOSIS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
INGROWING NAIL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
INTERTRIGO
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
LICHEN PLANUS
subjects affected / exposed	3 / 406 (0.74%)	0 / 406 (0.00%)
occurrences all number	3	0
LICHEN SCLEROSUS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
MILIARIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
NAIL DISCOLOURATION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
NAIL RIDGING
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
NIGHT SWEATS
subjects affected / exposed	13 / 406 (3.20%)	16 / 406 (3.94%)
occurrences all number	13	16
ONYCHOCLASIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
ONYCHOMADESIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PAIN OF SKIN
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences all number	1	3
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
PETECHIAE
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	2
PHOTOSENSITIVITY REACTION
subjects affected / exposed	2 / 406 (0.49%)	5 / 406 (1.23%)
occurrences all number	2	6
PIGMENTATION DISORDER
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PRURITUS
subjects affected / exposed	20 / 406 (4.93%)	27 / 406 (6.65%)
occurrences all number	23	30
PRURITUS GENERALISED
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PSORIASIS
subjects affected / exposed	2 / 406 (0.49%)	5 / 406 (1.23%)
occurrences all number	2	6
PURPURA
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
RASH
subjects affected / exposed	77 / 406 (18.97%)	119 / 406 (29.31%)
occurrences all number	92	160
RASH ERYTHEMATOUS
subjects affected / exposed	6 / 406 (1.48%)	4 / 406 (0.99%)
occurrences all number	6	4
RASH FOLLICULAR
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
RASH GENERALISED
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
RASH MACULAR
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
RASH MACULO-PAPULAR
subjects affected / exposed	4 / 406 (0.99%)	11 / 406 (2.71%)
occurrences all number	4	14
RASH PAPULAR
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences all number	1	3
RASH PRURITIC
subjects affected / exposed	5 / 406 (1.23%)	6 / 406 (1.48%)
occurrences all number	5	6
RASH VESICULAR
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
ROSACEA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
SEBORRHOEA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SKIN BURNING SENSATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SKIN DEPIGMENTATION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
SKIN DISORDER
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
SKIN EXFOLIATION
subjects affected / exposed	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences all number	1	4
SKIN HYPERPIGMENTATION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SKIN HYPOPIGMENTATION
subjects affected / exposed	3 / 406 (0.74%)	3 / 406 (0.74%)
occurrences all number	3	3
SKIN IRRITATION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
SKIN LESION
subjects affected / exposed	5 / 406 (1.23%)	7 / 406 (1.72%)
occurrences all number	5	7
SKIN SENSITISATION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
SKIN STRIAE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SKIN ULCER
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
SWELLING FACE
subjects affected / exposed	9 / 406 (2.22%)	3 / 406 (0.74%)
occurrences all number	10	4
URTICARIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
Renal and urinary disorders
ACUTE KIDNEY INJURY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BLADDER IRRITATION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BLADDER SPASM
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CALCULUS BLADDER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CHRONIC KIDNEY DISEASE
subjects affected / exposed	3 / 406 (0.74%)	1 / 406 (0.25%)
occurrences all number	3	1
DYSURIA
subjects affected / exposed	2 / 406 (0.49%)	3 / 406 (0.74%)
occurrences all number	2	3
HAEMATURIA
subjects affected / exposed	4 / 406 (0.99%)	4 / 406 (0.99%)
occurrences all number	5	4
HYDRONEPHROSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
NEPHROLITHIASIS
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	3	2
NOCTURIA
subjects affected / exposed	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences all number	1	4
POLLAKIURIA
subjects affected / exposed	5 / 406 (1.23%)	13 / 406 (3.20%)
occurrences all number	5	14
POLYURIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
PROTEINURIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
RENAL CYST
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
RENAL IMPAIRMENT
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
RENAL PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
URINARY INCONTINENCE
subjects affected / exposed	1 / 406 (0.25%)	5 / 406 (1.23%)
occurrences all number	1	5
URINARY RETENTION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
URINARY TRACT DISORDER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
URINE ODOUR ABNORMAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Endocrine disorders
ADRENAL MASS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
CUSHING'S SYNDROME
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
HYPERTHYROIDISM
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
HYPOTHYROIDISM
subjects affected / exposed	1 / 406 (0.25%)	7 / 406 (1.72%)
occurrences all number	1	7
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	71 / 406 (17.49%)	66 / 406 (16.26%)
occurrences all number	79	95
ARTHRITIS
subjects affected / exposed	3 / 406 (0.74%)	6 / 406 (1.48%)
occurrences all number	3	6
BACK PAIN
subjects affected / exposed	39 / 406 (9.61%)	34 / 406 (8.37%)
occurrences all number	43	39
BONE LOSS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
BONE PAIN
subjects affected / exposed	22 / 406 (5.42%)	9 / 406 (2.22%)
occurrences all number	23	11
BURSITIS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
CHONDROCALCINOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CHONDROCALCINOSIS PYROPHOSPHATE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
FISTULA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
FLANK PAIN
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
FOOT DEFORMITY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
GROIN PAIN
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
HAEMARTHROSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
INCLUSION BODY MYOSITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
INTERVERTEBRAL DISC PROTRUSION
subjects affected / exposed	3 / 406 (0.74%)	0 / 406 (0.00%)
occurrences all number	3	0
JAW CYST
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
JOINT LOCK
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
JOINT STIFFNESS
subjects affected / exposed	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences all number	1	4
JOINT SWELLING
subjects affected / exposed	12 / 406 (2.96%)	8 / 406 (1.97%)
occurrences all number	12	8
MOBILITY DECREASED
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
MUSCLE SPASMS
subjects affected / exposed	134 / 406 (33.00%)	14 / 406 (3.45%)
occurrences all number	179	18
MUSCLE TWITCHING
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
MUSCULAR WEAKNESS
subjects affected / exposed	4 / 406 (0.99%)	3 / 406 (0.74%)
occurrences all number	4	5
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	3 / 406 (0.74%)	6 / 406 (1.48%)
occurrences all number	3	6
MUSCULOSKELETAL DISCOMFORT
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences all number	3	2
MUSCULOSKELETAL PAIN
subjects affected / exposed	25 / 406 (6.16%)	22 / 406 (5.42%)
occurrences all number	30	23
MUSCULOSKELETAL STIFFNESS
subjects affected / exposed	3 / 406 (0.74%)	3 / 406 (0.74%)
occurrences all number	3	3
MYALGIA
subjects affected / exposed	46 / 406 (11.33%)	29 / 406 (7.14%)
occurrences all number	53	32
NECK MASS
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
NECK PAIN
subjects affected / exposed	7 / 406 (1.72%)	9 / 406 (2.22%)
occurrences all number	8	9
OSTEITIS DEFORMANS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
OSTEOARTHRITIS
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
OSTEOPOROSIS
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
PAIN IN EXTREMITY
subjects affected / exposed	53 / 406 (13.05%)	42 / 406 (10.34%)
occurrences all number	59	51
PAIN IN JAW
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences all number	1	3
PERIARTHRITIS
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
PLANTAR FASCIITIS
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
PLICA SYNDROME
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
RHABDOMYOLYSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ROTATOR CUFF SYNDROME
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SACROILIITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SOFT TISSUE SWELLING
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SPINAL OSTEOARTHRITIS
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
SPINAL PAIN
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SYNOVIAL CYST
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
TEMPOROMANDIBULAR JOINT SYNDROME
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
TENDON PAIN
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
TENDONITIS
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
TRIGGER FINGER
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
TRISMUS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
Infections and infestations
ABDOMINAL INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ABSCESS
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
ANAL ABSCESS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
ANAL INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ARTHRITIS BACTERIAL
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
BODY TINEA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BREAST CELLULITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
BRONCHITIS
subjects affected / exposed	0 / 406 (0.00%)	4 / 406 (0.99%)
occurrences all number	0	4
CAMPYLOBACTER INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
CANDIDA INFECTION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
CELLULITIS
subjects affected / exposed	8 / 406 (1.97%)	9 / 406 (2.22%)
occurrences all number	10	12
CLOSTRIDIUM DIFFICILE INFECTION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
CONJUNCTIVITIS
subjects affected / exposed	10 / 406 (2.46%)	4 / 406 (0.99%)
occurrences all number	12	4
CYSTITIS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
DIABETIC FOOT INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
EAR INFECTION
subjects affected / exposed	13 / 406 (3.20%)	11 / 406 (2.71%)
occurrences all number	15	12
ENTERITIS INFECTIOUS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ENTEROBIASIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	2
EPIDIDYMITIS
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
ESCHERICHIA URINARY TRACT INFECTION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
EYE INFECTION
subjects affected / exposed	3 / 406 (0.74%)	5 / 406 (1.23%)
occurrences all number	3	5
EYE INFECTION VIRAL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
EYELID INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
FOLLICULITIS
subjects affected / exposed	1 / 406 (0.25%)	10 / 406 (2.46%)
occurrences all number	1	10
FUNGAL INFECTION
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
FUNGAL SKIN INFECTION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
FURUNCLE
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
GASTROENTERITIS
subjects affected / exposed	2 / 406 (0.49%)	7 / 406 (1.72%)
occurrences all number	2	8
GASTROENTERITIS NOROVIRUS
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences all number	3	2
GASTROENTERITIS VIRAL
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
GASTROINTESTINAL VIRAL INFECTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
GENITAL ABSCESS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
GINGIVITIS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
GROIN ABSCESS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HELICOBACTER INFECTION
subjects affected / exposed	2 / 406 (0.49%)	2 / 406 (0.49%)
occurrences all number	2	2
HEPATITIS B
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
HERPES OPHTHALMIC
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HERPES SIMPLEX
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	3
HERPES ZOSTER
subjects affected / exposed	10 / 406 (2.46%)	7 / 406 (1.72%)
occurrences all number	15	8
HORDEOLUM
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
INFECTED BITE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
INFECTED DERMAL CYST
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
INFECTION
subjects affected / exposed	6 / 406 (1.48%)	8 / 406 (1.97%)
occurrences all number	6	8
INFECTIOUS MONONUCLEOSIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
INFECTIVE GLOSSITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
INFECTIVE KERATITIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
INFLUENZA
subjects affected / exposed	4 / 406 (0.99%)	8 / 406 (1.97%)
occurrences all number	4	8
INJECTION SITE INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
INTERVERTEBRAL DISCITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	2
KIDNEY INFECTION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	2
LABYRINTHITIS
subjects affected / exposed	3 / 406 (0.74%)	6 / 406 (1.48%)
occurrences all number	3	6
LOCALISED INFECTION
subjects affected / exposed	2 / 406 (0.49%)	4 / 406 (0.99%)
occurrences all number	2	4
LOWER RESPIRATORY TRACT INFECTION
subjects affected / exposed	55 / 406 (13.55%)	68 / 406 (16.75%)
occurrences all number	73	93
LUNG INFECTION
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
LYMPH GLAND INFECTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
LYMPH NODE ABSCESS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
MALARIA
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
NAIL INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
NASOPHARYNGITIS
subjects affected / exposed	26 / 406 (6.40%)	32 / 406 (7.88%)
occurrences all number	34	39
ONYCHOMYCOSIS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
ORAL CANDIDIASIS
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences all number	1	3
ORAL FUNGAL INFECTION
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
ORAL HERPES
subjects affected / exposed	6 / 406 (1.48%)	13 / 406 (3.20%)
occurrences all number	6	17
ORAL INFECTION
subjects affected / exposed	1 / 406 (0.25%)	5 / 406 (1.23%)
occurrences all number	1	5
OTITIS EXTERNA
subjects affected / exposed	3 / 406 (0.74%)	1 / 406 (0.25%)
occurrences all number	3	1
OTITIS MEDIA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
OTITIS MEDIA ACUTE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
PARONYCHIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PAROTITIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
PHARYNGITIS
subjects affected / exposed	6 / 406 (1.48%)	10 / 406 (2.46%)
occurrences all number	6	10
PNEUMONIA
subjects affected / exposed	1 / 406 (0.25%)	5 / 406 (1.23%)
occurrences all number	1	5
POST PROCEDURAL INFECTION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
RASH PUSTULAR
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
RESPIRATORY TRACT INFECTION
subjects affected / exposed	3 / 406 (0.74%)	5 / 406 (1.23%)
occurrences all number	3	5
RHINITIS
subjects affected / exposed	3 / 406 (0.74%)	4 / 406 (0.99%)
occurrences all number	3	4
RHINOVIRUS INFECTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SEPSIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
SIALOADENITIS
subjects affected / exposed	0 / 406 (0.00%)	2 / 406 (0.49%)
occurrences all number	0	2
SINUSITIS
subjects affected / exposed	4 / 406 (0.99%)	13 / 406 (3.20%)
occurrences all number	4	14
SKIN CANDIDA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
SKIN INFECTION
subjects affected / exposed	4 / 406 (0.99%)	2 / 406 (0.49%)
occurrences all number	4	4
SOFT TISSUE INFECTION
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
STAPHYLOCOCCAL INFECTION
subjects affected / exposed	2 / 406 (0.49%)	0 / 406 (0.00%)
occurrences all number	2	0
STREPTOCOCCAL INFECTION
subjects affected / exposed	3 / 406 (0.74%)	0 / 406 (0.00%)
occurrences all number	3	0
STRONGYLOIDIASIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	2	0
TINEA CRURIS
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
TINEA INFECTION
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
TINEA PEDIS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
TONSILLITIS
subjects affected / exposed	3 / 406 (0.74%)	2 / 406 (0.49%)
occurrences all number	3	2
TOOTH ABSCESS
subjects affected / exposed	4 / 406 (0.99%)	11 / 406 (2.71%)
occurrences all number	4	11
TOOTH INFECTION
subjects affected / exposed	5 / 406 (1.23%)	4 / 406 (0.99%)
occurrences all number	6	6
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	33 / 406 (8.13%)	39 / 406 (9.61%)
occurrences all number	36	50
URINARY TRACT INFECTION
subjects affected / exposed	21 / 406 (5.17%)	32 / 406 (7.88%)
occurrences all number	29	47
VAGINAL INFECTION
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
VARICELLA
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
VIRAL INFECTION
subjects affected / exposed	9 / 406 (2.22%)	17 / 406 (4.19%)
occurrences all number	11	18
VIRAL PHARYNGITIS
subjects affected / exposed	2 / 406 (0.49%)	1 / 406 (0.25%)
occurrences all number	2	1
VIRAL RASH
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
VIRAL UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	2 / 406 (0.49%)	3 / 406 (0.74%)
occurrences all number	2	3
VULVOVAGINAL CANDIDIASIS
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
WOUND INFECTION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
Metabolism and nutrition disorders
ALCOHOL INTOLERANCE
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
DECREASED APPETITE
subjects affected / exposed	18 / 406 (4.43%)	31 / 406 (7.64%)
occurrences all number	21	34
DEHYDRATION
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	1	1
DIABETES MELLITUS
subjects affected / exposed	1 / 406 (0.25%)	2 / 406 (0.49%)
occurrences all number	1	2
DIABETES MELLITUS INADEQUATE CONTROL
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
FLUID RETENTION
subjects affected / exposed	16 / 406 (3.94%)	14 / 406 (3.45%)
occurrences all number	18	14
FOLATE DEFICIENCY
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
FOOD INTOLERANCE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
GOUT
subjects affected / exposed	9 / 406 (2.22%)	12 / 406 (2.96%)
occurrences all number	12	14
HYPERCHOLESTEROLAEMIA
subjects affected / exposed	0 / 406 (0.00%)	5 / 406 (1.23%)
occurrences all number	0	5
HYPERKALAEMIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	2
HYPERLIPIDAEMIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HYPERNATRAEMIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HYPERTRIGLYCERIDAEMIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HYPOCALCAEMIA
subjects affected / exposed	6 / 406 (1.48%)	3 / 406 (0.74%)
occurrences all number	6	7
HYPOGLYCAEMIA
subjects affected / exposed	1 / 406 (0.25%)	3 / 406 (0.74%)
occurrences all number	1	4
HYPOKALAEMIA
subjects affected / exposed	4 / 406 (0.99%)	2 / 406 (0.49%)
occurrences all number	8	2
HYPOMAGNESAEMIA
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
HYPOPHOSPHATAEMIA
subjects affected / exposed	1 / 406 (0.25%)	1 / 406 (0.25%)
occurrences all number	14	1
INCREASED APPETITE
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
IRON DEFICIENCY
subjects affected / exposed	0 / 406 (0.00%)	3 / 406 (0.74%)
occurrences all number	0	3
TETANY
subjects affected / exposed	1 / 406 (0.25%)	0 / 406 (0.00%)
occurrences all number	1	0
TUMOUR LYSIS SYNDROME
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
TYPE 2 DIABETES MELLITUS
subjects affected / exposed	0 / 406 (0.00%)	1 / 406 (0.25%)
occurrences all number	0	1
VITAMIN D DEFICIENCY
subjects affected / exposed	1 / 406 (0.25%)	4 / 406 (0.99%)
occurrences all number	1	4

More information

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Were there any global substantial amendments to the protocol? Yes

08 Jun 2016

The protocol was updated as regarding guidance on management of pleural effusions and the addition of concerns around pulmonary arterial hypertension. The requirement for bone marrow trephine was removed. For laboratory evaluations, LDH was changed to optional, lymphocyte count added and only one test for either AST or ALT was made acceptable. The definition of serious adverse events was updated to include new malignancies and CML disease progression. The section on study drug dose escalation was updated. Drug storage conditions and contraindications were updated to reflect the SmPC. Amendments also allowed GCSF to be given as a concomitant medication and advice regarding QT prolongation with TKIs was updated. The contact details for trials team, sponsor and central laboratory were updated.

12 Dec 2016

The protocol was updated to allow the use of generic imatinib, to remove the requirement for bone marrow aspirate samples, to correct SAE definitions and other typographical errors and inconsistencies.

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.

The additional endpoint of broad comparative costs between the regimens as described in the protocol, was not analysed at the end of study as there was no beneficial reason to do so when imatinib became generic in Dec 2016 at vastly reduced cost.

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Clinical trials

Clinical Trial Results:
STI571 Prospective International RandomIsed Trial 2 - A phase III, prospective randomised comparison of imatinib (STI571, Glivec/Gleevec) 400mg daily versus dasatinib (Sprycel) 100mg daily in patients with newly-diagnosed chronic phase chronic myeloid leukaemia.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Event free survival at 5 years

Primary: Event free survival at 5 years

Secondary: Rate of complete cytogenetic response

Secondary: Rate of complete cytogenetic response

Secondary: Rate of treatment failure

Secondary: Rate of treatment failure

Secondary: Rate of complete haematological response

Secondary: Rate of complete haematological response

Secondary: Level of molecular responses by PCR on first line therapy

Secondary: Level of molecular responses by PCR on first line therapy

Secondary: Quality of Life

Secondary: Quality of Life

Secondary: Overall survival

Secondary: Overall survival

Secondary: Tolerability between the regimens

Secondary: Tolerability between the regimens

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Greece
Hungary
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Italy
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Outside EU/EEA

Clinical trials

Clinical Trial Results: STI571 Prospective International RandomIsed Trial 2 - A phase III, prospective randomised comparison of imatinib (STI571, Glivec/Gleevec) 400mg daily versus dasatinib (Sprycel) 100mg daily in patients with newly-diagnosed chronic phase chronic myeloid leukaemia.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Event free survival at 5 years

Primary: Event free survival at 5 years

Secondary: Rate of complete cytogenetic response

Secondary: Rate of complete cytogenetic response

Secondary: Rate of treatment failure

Secondary: Rate of treatment failure

Secondary: Rate of complete haematological response

Secondary: Rate of complete haematological response

Secondary: Level of molecular responses by PCR on first line therapy

Secondary: Level of molecular responses by PCR on first line therapy

Secondary: Quality of Life

Secondary: Quality of Life

Secondary: Overall survival

Secondary: Overall survival

Secondary: Tolerability between the regimens

Secondary: Tolerability between the regimens

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
STI571 Prospective International RandomIsed Trial 2 - A phase III, prospective randomised comparison of imatinib (STI571, Glivec/Gleevec) 400mg daily versus dasatinib (Sprycel) 100mg daily in patients with newly-diagnosed chronic phase chronic myeloid leukaemia.