Download PDF

Clinical Trial Results:
Phase III, multicentre, open-label, prospective randomised trial comparing Imatinib alone at 400mg versus 800mg daily versus Imatinib 400mg daily plus PEG Interferon-alpha with newly diagnosed chronic myeloid leukaemia

Summary
EudraCT number	2004-001622-24
Trial protocol	IE
Global end of trial date	15 Jan 2014

Results information
Results version number	v1(current)
This version publication date	08 Sep 2016
First version publication date	08 Sep 2016
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

Spirit Version 16

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Newcastle upon Tyne Hospitals NHS Trust

Sponsor organisation address

Freeman Hospital, Freeman Road, Newcastle upon Tyne, United Kingdom, NE7 7DN

Public contact

Spirit Trials Secretary, Spirit Trials Office, 0044 0191 282 0904, enu-tr.spirittrials@nhs.net

Scientific contact

Stephen O'Brien, Newcastle Clinical Trials Unit, 0044 0191 282 0904, 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

10 Feb 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 Jan 2014

Was the trial ended prematurely?

Yes

Main objective of the trial

To determine overall survival at 5 years

Protection of trial subjects

No specific protection in addition to standard care offered to chronic myeloid leukaemia patients

Background therapy

Evidence for comparator

The rationale for combining imatinib with interferon alpha is based on pre-clinical data that demonstrates additive to synergistic anti-proliferative activity of these agents against leukaemic cells in vitro. Clinical studies have shown that the agents, when given in combination, produce higher rates of cytogenetic responses despite using low doses of imatinib. The rationale for using a higher dose of imatinib comes from early studies in newly diagnosed CML patients in chronic phase where a higher cytogenetic response was seen in the higher dose (800mg/day) group than the standard dose (400mg/day) group, 74% versus 59% respectively.

Actual start date of recruitment

03 Jun 2005

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: 259

Worldwide total number of subjects

259

EEA total number of subjects

259

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)

208

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Recruitment opened in June 2005 and closed on 1st February 2009. During that period 259 patients were recruited at 66 sites in the UK.

Screening details

Patients only entered screening if they had newly diagnosed chronic myeloid leukaemia in chronic phase. Patients could not be taking any drug therapy for their leukaemia other than hydroxycarbamide on analgrelide and have not undergone bone marrow transplantation. All screening assessments had to be carried out within 14 days of randomisation.

Period 1 title

On Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Imatinib 400mg

Arm description

Imatinib 400mg daily

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

Take one 400mg tablet once daily

Imatinib 800mg

Arm description

Imatinib 800mg daily

Arm type

Experimental

Investigational medicinal product name

Imatinib

Investigational medicinal product code

Other name

Glivec

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Take one 400mg tablet twice daily

Imatinib 400mg + INF

Arm description

Pegylated interferon-alpha and imatinib

Arm type

Experimental

Investigational medicinal product name

Imatinib

Investigational medicinal product code

Other name

Glivec

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Take one 400mg tablet once daily

Investigational medicinal product name

pegylated interferon-alpha

Investigational medicinal product code

Other name

Pegasys

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Starting with dose of 90 micrograms of Pegasys to be given once a week every 4 weeks for 3 weeks, followed by once a week every 2 weeks for a further 4 weeks then once a week every week for 6 weeks then dose increased to 180 micrograms once every week for rest of study period.

Number of subjects in period 1	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Started	99	96	64
Start Of Treatment	98	96	64
Treatment Discontinuation	98	96	64
Completed	52	39	12
Not completed	47	57	52
Adverse event, serious fatal	4	1	2
Consent withdrawn by subject	1	4	3
Adverse event, non-fatal	7	26	26
Other Reasons	4	10	4
Lost to follow-up	1	-	-
Lack of efficacy	28	16	14
Protocol deviation	2	-	3

Period 2 title

Off Treatment Period

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Imatinib 400mg

Arm description

Imatinib 400mg daily

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

Take one 400mg tablet once daily

Imatinib 800mg

Arm description

Imatinib 800mg daily

Arm type

Experimental

Investigational medicinal product name

Imatinib

Investigational medicinal product code

Other name

Glivec

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Take one 400mg tablet twice daily

Imatinib 400mg + INF

Arm description

Pegylated interferon-alpha and imatinib

Arm type

Experimental

Investigational medicinal product name

Imatinib

Investigational medicinal product code

Other name

Glivec

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Take one 400mg tablet once daily

Investigational medicinal product name

pegylated interferon-alpha

Investigational medicinal product code

Other name

Pegasys

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Number of subjects in period 2	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Started	52	39	12
Completed	52	39	12

Baseline characteristics

Top of page

Reporting group title

Imatinib 400mg

Reporting group description

Imatinib 400mg daily

Reporting group title

Imatinib 800mg

Reporting group description

Imatinib 800mg daily

Reporting group title

Imatinib 400mg + INF

Reporting group description

Pegylated interferon-alpha and imatinib

Reporting group values	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF	Total
Number of subjects	99	96	64	259
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	0	0	0	0
Adults (18-64 years)	78	80	50	208
From 65-84 years	21	16	14	51
85 years and over	0	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	52.414 ± 13.771	52.073 ± 13.406	53.75 ± 13.406	-
Gender categorical
Units: Subjects
Female	39	36	22	97
Male	60	60	42	162
Weight
Units: kg
arithmetic mean (standard deviation)	77.426 ± 16.686	81.867 ± 19.63	77.389 ± 15.698	-
Height
Units: meters
arithmetic mean (standard deviation)	1.699 ± 0.089	1.713 ± 0.094	1.707 ± 0.109	-
BMI
Body Mass Index
Units: Kg/(m^2)
arithmetic mean (standard deviation)	26.639 ± 4.987	27.739 ± 6.708	26.3 ± 4.003	-

Subject analysis set title

Full Analysis Set

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	Full Analysis Set	Safety Set
Number of subjects	258	258
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	207	207
From 65-84 years	51	51
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	52.659 ± 13.155	52.659 ± 13.155
Gender categorical
Units: Subjects
Female	96	96
Male	162	162
Weight
Units: kg
arithmetic mean (standard deviation)	78.579 ± 18.996	78.579 ± 18.996
Height
Units: meters
arithmetic mean (standard deviation)	1.706 ± 0.096	1.706 ± 0.096
BMI
Body Mass Index
Units: Kg/(m^2)
arithmetic mean (standard deviation)	26.994 ± 5.558	26.994 ± 5.558

End points

Top of page

Reporting group title

Imatinib 400mg

Reporting group description

Imatinib 400mg daily

Reporting group title

Imatinib 800mg

Reporting group description

Imatinib 800mg daily

Reporting group title

Imatinib 400mg + INF

Reporting group description

Pegylated interferon-alpha and imatinib

Reporting group title

Imatinib 400mg

Reporting group description

Imatinib 400mg daily

Reporting group title

Imatinib 800mg

Reporting group description

Imatinib 800mg daily

Reporting group title

Imatinib 400mg + INF

Reporting group description

Pegylated interferon-alpha and imatinib

Subject analysis set title

Full Analysis Set

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: Overall Survival at 5 Years

Top of page

End point title

Overall Survival at 5 Years

End point description

To compare overall survival in the three arms at 5 years

End point type

Primary

End point timeframe

5 years

End point values	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Number of subjects analysed	98 ^[1]	96 ^[2]	64 ^[3]
Units: Patients Alive at 5 Years
Patients Alive	27	19	8
Patients Died	71	77	56

Attachments

Kaplan-Meier plot

Notes
[1] - Full Analysis Set
[2] - Full Analysis Set
[3] - Full Analysis Set

Kaplan-Meier

Statistical analysis description

The proportion of patients surviving to 5 years will be summarised by treatment group for the FAS. A Kaplan-Meier Plot will be produced using the following method of censoring: Patients discontinuing study medication for any reason other than death will be censored at the time of discontinuation from study drug. For Overall Survival, irrespective of any further follow-up/last contact information.

Comparison groups

Imatinib 800mg v Imatinib 400mg v Imatinib 400mg + INF

Number of subjects included in analysis

258

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0246 ^[4]

Method

Logrank

Confidence interval

Notes
[4] - The Log-Rank test was planned in the protocol, however due to the lack of sample size, the study is underpowered, and therefore this hypotesis test will not be performed.

Secondary: Molecular Response

Top of page

End point title

Molecular Response

End point description

To compare the level of molecular response (BCR-ABL/ABL ratio by real time PCR after one year of study therapy in each of the treatment arms.

End point type

Secondary

End point timeframe

After 1 year of therapy (Visit 7).

End point values	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Number of subjects analysed	98 ^[5]	96 ^[6]	64 ^[7]
Units: Patients with Molecular Response
Molecular Response 3 (MR3) - PCR <0.1%	23	33	18
Molecular Response 4 (MR4) - PCR <0.01%	7	9	10
Molecular Response 4.5 (MR4.5) - PCR <0.0032%	3	3	5
No Molecular Response	65	51	31

Notes
[5] - Full Analysis Set
[6] - Full Analysis Set
[7] - Full Analysis Set

No statistical analyses for this end point

Secondary: Time to Progression

Top of page

End point title

Time to Progression

End point description

To compare time to progression in the three arms of the study according to progression definitions in protocol.

End point type

Secondary

End point timeframe

From start of therapy to protocol definition of progression.

End point values	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Number of subjects analysed	96 ^[8]	93 ^[9]	64 ^[10]
Units: Months
arithmetic mean (standard deviation)	40.4 ± 23.94	34.38 ± 23.69	22.22 ± 21.77

Notes
[8] - Selection of Patients with Available data for the Endpoint from Full Analysis Set
[9] - Selection of Patients with Available data for the Endpoint from Full Analysis Set
[10] - Selection of Patients with Available data for the Endpoint from Full Analysis Set

No statistical analyses for this end point

Secondary: Time to Treatment Failure

Top of page

End point title

Time to Treatment Failure

End point description

To compare time to treatment failure in the three arms of the study.

End point type

Secondary

End point timeframe

From start of treatment to documented protocol defined treatment failure.

End point values	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Number of subjects analysed	98 ^[11]	96 ^[12]	64 ^[13]
Units: Months
arithmetic mean (standard deviation)	44.57 ± 27.37	50.98 ± 24.41	47.36 ± 25.58

Notes
[11] - Full Analysis Set
[12] - Full Analysis Set
[13] - Full Analysis Set

No statistical analyses for this end point

Secondary: Rate of Cytogenetic Response

Top of page

End point title

Rate of Cytogenetic Response

End point description

To compare rate of cytogenetic responses (major and complete) at one year and the cumulative incidence of such responses with each of the regimens.

End point type

Secondary

End point timeframe

At 1 year after study treatment started (Visit 7).

End point values	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Number of subjects analysed	98 ^[14]	96 ^[15]	64 ^[16]
Units: Patients
No cytogenetic response	35	22	17
Major cytogenetic response	36	40	26
Complete cytogenetic response	27	34	21

Notes
[14] - Full Analysis Set
[15] - Full Analysis Set
[16] - Full Analysis Set

No statistical analyses for this end point

Secondary: Complete Haematological Response Rate

Top of page

End point title

Complete Haematological Response Rate

End point description

To compare the rates of complete haematological response in patients treated with all regimens.

End point type

Secondary

End point timeframe

Whole 5 year study period

End point values	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Number of subjects analysed	98 ^[17]	96 ^[18]	64 ^[19]
Units: Patients
Hematological Responders	93	88	61
Hematological Non-Responders	5	8	3

Notes
[17] - Full Analysis Set Patients
[18] - Full Analysis Set Patients
[19] - Full Analysis Set Patients

No statistical analyses for this end point

Secondary: Tolerability

Top of page

End point title

Tolerability

End point description

To compare tolerability of these regimens.

End point type

Secondary

End point timeframe

Whole 5 year study period.

End point values	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Number of subjects analysed	98 ^[20]	96 ^[21]	64 ^[22]
Units: Patients with AE Related to Study Drug
Patients who experienced AEs Related to Study Drug	76	89	55
Patient without AEs Related to Study Drug	22	7	9

Notes
[20] - Full Analysis Set
[21] - Full Analysis Set
[22] - Full Analysis Set

No statistical analyses for this end point

Secondary: Quality of Life

Top of page

End point title

Quality of Life

End point description

To assess quality of life on each of the 3 arms.

End point type

Secondary

End point timeframe

At 1 year from the baseline visit (visit 7).

End point values	Imatinib 400mg	Imatinib 800mg	Imatinib 400mg + INF
Number of subjects analysed	98 ^[23]	96 ^[24]	64 ^[25]
Units: Quality of life Scores
arithmetic mean (standard deviation)
FACT-G / Total Score / Baseline	83.96 ± 15.57	82.13 ± 16.99	84.13 ± 15.03
EQ-5D / VAS Score / Baseline	58 ± 35.58	54.82 ± 32.94	69.71 ± 30.69
FACT-BRM / Total Outcome Index / Baseline	82.21 ± 18.07	78.39 ± 19.83	85.12 ± 18.7
FACT-G / Total Score / 12 Months	87.66 ± 16.57	82.21 ± 19.1	88.26 ± 11.87
EQ-5D / VAS Score / 12 Months	71.34 ± 32.03	70.5 ± 27.88	71.25 ± 33.33
FACT-BRM / Total Outcome Index / 12 Months	84.92 ± 17.7	77.91 ± 24.03	83.31 ± 14.81

Notes
[23] - Full Analysis Set
[24] - Full Analysis Set
[25] - Full Analysis Set

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From date of signed informed consent to 4 weeks post last dose of study drug taken for each subject

Adverse event reporting additional description

Adverse events collected by physician, reported by patient or from laboratory tests

Assessment type

Non-systematic

Dictionary name

Reported Term

Dictionary version

Reporting group title

Imatinib 400mg

Reporting group description

Imatinib 400mg daily

Reporting group title

Imatinib 400mg + INF

Reporting group description

Pegylated interferon-alpha and imatinib

Reporting group title

Imatinib 800mg

Reporting group description

Imatinib 800mg daily

Serious adverse events	Imatinib 400mg	Imatinib 400mg + INF	Imatinib 800mg
Total subjects affected by serious adverse events
subjects affected / exposed	19 / 89 (21.35%)	10 / 62 (16.13%)	24 / 107 (22.43%)
number of deaths (all causes)	11	9	6
number of deaths resulting from adverse events	0	0	0
General disorders and administration site conditions
ABDOMINAL PAIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ACUTE CORONARY SYNDROME
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ACUTE RENAL FALIURE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ADENOCARCINOMA (GI)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ADENOCARCINOMA OF GI ORIGIN
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ADMITTED TO HOSPITAL WITH SEVERE BONE PAIN ? DUE TO LOW WCC
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
AGITATION DUE TO INFECTED RIGHT TOTAL KNEE REPLACEMENT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ALT RESULT 174-TRIAL DRUGS TEMPORARY STOPPED AWAITING HEPATOLOGY OPINION
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ANAEMIA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ANGIOEDEMA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
BLADDER CANCER
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
BLAST CRISIS OF CML
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
BLURRED VISION (PERSISTANT MIGRAINE AURA)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
BONE PAIN IN PELVIS AND THIGHS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CALF HAEMATOMA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CAMPYLOBACTER GASTROENTERITIS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CARCINOMA OF PROSTATE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CARDIAC ISCHEMIA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CEREBRAL INFARCTION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CHEST INFECTION
subjects affected / exposed	2 / 89 (2.25%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CHRONIC RENAL FAILURE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CML TRANSFORMED TO AML
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
CONFUSION DUE TO INFECTED RIGHT TOTAL KNEE REPLACEMENT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
COUGH AND MILD FEVER
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CVA/ VENOUS SINUS THROMBOSIS WITH SECONDARY HAEMORRHAGE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DEHYDRATION
subjects affected / exposed	1 / 89 (1.12%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DERANGED LFTS (BORDERLINE GRADE 3 TOXICITY) - ZONE 3 HEPATIC NECROSIS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DIARRHOEA
subjects affected / exposed	1 / 89 (1.12%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DIARRHOEA AND VOMITING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DIFFUSE LARGE B-CELL LYMPHOMA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
EPIGASTRIC PAIN
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
EXACERBATION OF COPD
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
FAST ATRIAL FIBRILATION AND GRADE 3 PLATELET TOXICITY
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
FATIGUE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
FEVER (WITH NORMAL NEUTROPHILS)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
GLOSSAL SWELLING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
GRADUAL DECREASE IN FULL BLOOD COUNT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HEADACHES VOMITING, LOOSE BOWELS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HEPATO-TOXICITY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
INFECTION
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
INFECTIVE EXACERBATION OF FIBROSING ALVEOLITIS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
INSOMNIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
INTENTIONAL OVERDOSE OF ZOPICLONE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
LEFT PNEUMOTHORAX
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
LEFT SIDED STROKE (CVA)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
LEFT SUBCONJUNCTIVAL HAEMORRHAGE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
LICHEN PLANUS ON TONGUE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
LOSS OF CONCIOUSNESS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
LOW PHOSPHATES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
LOWER LEFT ABDOMINAL PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
LOWER RESPIRATORY TRACT INFECTION
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
MENINGOCOCCAL SEPSIS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
MENORRAGHIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
NAUSEA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
NAUSEA/SICKNESS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
NEUTROPENIA
subjects affected / exposed	1 / 89 (1.12%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PAIN IN RIGHT LEG FOLLOWING BONE MARROW PROCEDURE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PELVIC AND THIGH BONE PAIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PNEUMONIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PNEUMONITIS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PROBABLE ATRIAL FIBRILLATION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PROSTATE CANCER
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PT PARTNER MISCARRIED
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PULMONARY EMBOLISM
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PYREXIA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
RAISED CREATININE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
RENAL FAILURE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
RESTRICTIVE CARDIOMYOPATHY
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
RIGORS / CHILLS - FLUE LIKE SYMPTOMS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SEPTIC EVENT POST TOTAL KNEE REPLACEMENT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SEVERE LOW PRESSUREHEADACHE AS A RESULT OF A CSF LEAK.
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SEVERE MUSCULOSKELETAL PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SEVERE THROAT INFECTION
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SHINGLES
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SHORTNESS OF BREATH (PULMONARY OEDEMA&PNEUMONIA)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SWOLLEN UPPER LIP
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
TOOK AN OVERDOSE OF IMATINIB
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
TRANSFORMATION TO PRE B- CELL ALL.
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
VERY LOW MOOD
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
VOMITING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
VOMITTING
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
WORSENING OF CHRONIC FIBROSING ALVEOLITIS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Imatinib 400mg	Imatinib 400mg + INF	Imatinib 800mg
Total subjects affected by non serious adverse events
subjects affected / exposed	88 / 89 (98.88%)	61 / 62 (98.39%)	91 / 107 (85.05%)
General disorders and administration site conditions
"FRAGILE SKIN"
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	2
1 WEEK OF FLU LIKE SYMPTOMS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
2 DAYS OF FLU LIKE SYMPTOMS AFTER PEG-INTERFON
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ACUTE VERTIGO, LOUD NOISE, NUMBNESS OF FACE. ATYPICAL MENIERE'S DISEASE.
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
? INFECTED RIGHT KNEE JOINT
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
? PITYRIASIS LICHENOIDES CHRONICA ON LEGS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ABDOMENAL PAIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ABDOMINAL BLOATING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ABDOMINAL CRAMPS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	2 / 107 (1.87%)
occurrences all number	0	1	2
ABDOMINAL DISCOMFORT
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ABDOMINAL OEDEMA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ABDOMINAL PAIN
subjects affected / exposed	1 / 89 (1.12%)	3 / 62 (4.84%)	5 / 107 (4.67%)
occurrences all number	1	3	5
ABDOMINAL PAIN AND OCCASIONAL CRAMPS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ABDOMINAL PAIN, INCREASED BURPING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ABNORMAL LFT'S
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ABSOULTE NEUTROPHIL COUNT
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ACHES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ACHES AND PAINS IN BOTH THIGHS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ACHES AND PAINS IN JOINTS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ACHES AND PAINS IN LEGS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ACHES IN BODY
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	4
ACHES IN HIPS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ACHES IN LEGS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	0	0	2
ACHING BONES
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ACHING JOINTS
subjects affected / exposed	1 / 89 (1.12%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	1	1	0
ACHING JOINTS AND FLU SYMPTOMS RELATED TO FLU JAB
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ACHING LEGS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	0	0	2
ACHING LEGS, SHOULDERS AND CALVES
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ACHING MUSCLES
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	1 / 107 (0.93%)
occurrences all number	0	1	1
ACHING THIGH BONES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ACHING THIGHS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ACHING THIGHS AND GROIN AREAS BILATERALLY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ACID REFLUX
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
ACOUSTIC NUEROMA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
AGGITATION
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
AGITATION/ ANXIETY
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ALLERGIC REACTION (SWOLLEN TONGUE AND NECK)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ALLERGIC REACTION -SWOLLEN TONGUE DURING A MEAL. CAUSE UNKNOWN OF WHICH FOOD ITEM
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ALLERGIC REACTION ? CAUSE AFFECTS TONGUE SWOLLEN AND FLUID COLLECTS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ALLERGIC REACTION AT SITE OF PNEUMOVAX INJECTION (ARM)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ALLERGIC REACTION TO LISINOPRIL
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ALTERED BOWEL FUNCTION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ALTERED SENSE OF TASTE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ALTERED TASTE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ALTERNATING CONSTIPATION AND DIARRHOEA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ALTERNATING DIARRHOEA AND CONSTIPATION
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ALTHRALGIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
AMENORRHOEA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ANAEMIA
subjects affected / exposed	7 / 89 (7.87%)	5 / 62 (8.06%)	5 / 107 (4.67%)
occurrences all number	8	11	6
ANAEMIA HB 10.9G/DL
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ANAL FISSURE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	1 / 107 (0.93%)
occurrences all number	0	1	1
ANEMIA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
ANGINA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ANKEL OEDEMA, PUFFY EYES AND FEW CHEST SOUNDS AT RIGHT BASE.
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ANKLE ODEMA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ANKLE OEDEMA
subjects affected / exposed	1 / 89 (1.12%)	4 / 62 (6.45%)	3 / 107 (2.80%)
occurrences all number	1	5	3
ANOREXIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	5 / 107 (4.67%)
occurrences all number	0	0	5
ANXIETY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ANXIOUS/PALPITATIONS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
APHTHOUS ULCERS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ARTHRALGIA
subjects affected / exposed	0 / 89 (0.00%)	2 / 62 (3.23%)	3 / 107 (2.80%)
occurrences all number	0	2	3
ARTHRALGIA (R LEG)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ARTHRALGIA + MYALGIA
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ARTHRALGIA ONLY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ARTHRALGIA/MYALGIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ARTHROSCOPY LEFT KNEE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ASTENIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ATRIAL FIBRILLATION
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ATTACK OF GOUT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BACK ACHE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	0	0	2
BACK AND HIP PAIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BACK PAIN
subjects affected / exposed	2 / 89 (2.25%)	2 / 62 (3.23%)	5 / 107 (4.67%)
occurrences all number	2	2	5
BACK PAIN, RSIDED LOWER RIBS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BACKACHE AND NECK PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BI-LATERAL SUBMANDIBULAR LYMPHADENOPATHY
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BILATERAL ANKLE OEDEMA IN BOTH LEGS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BILATERAL ANKLE RASH
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
BILATERAL LOIN PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BILATERAL OEDEMA IN BOTH LEGS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
BILIARY REFLUX
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BLACKOUTS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLEED INTO RIGHT EYE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BLEEDING AROUND EYES
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
BLEEDING FROM BOWELS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLEEDING GIMS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BLEEDING LEFT EYE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BLISTERING RASH ON LEGS WHICH BECAME INFECTED
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLOOD BLISTER IN MOUTH
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLOOD BLISTER ON RIGHT WRIST
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLOOD BLISTERS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLOOD BLISTERS AROUND WRISTS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLOOD SHOT EYES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLOODSHOT LEFT EYE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLOTCHY SKIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLUE TINGE TO TOES AND COLD FEET
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BLURRED VISION
subjects affected / exposed	1 / 89 (1.12%)	1 / 62 (1.61%)	1 / 107 (0.93%)
occurrences all number	2	1	1
BLURRED VISION - BILATERAL
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BLURRED VISION LEFT EYE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
BLURRED VISION.
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BONE AND JOINT PAIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BONE PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	7 / 107 (6.54%)
occurrences all number	1	0	7
BONE PAIN, - BACK, LEGS AND RIBS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BONEY ACHES AND PAIN
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
BONEY PROMINENCE RIGHT ELBOW - NEW
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BOWEL FREQUENCY
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BREAST INFECTION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BREATHLESSNESS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	2	0	2
BRONCHITIS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
BRUISED AROUND INJECTION SITE FROM INSULIN
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
BRUISED LEGS (VERY LARGE BRUISES)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BRUISING
subjects affected / exposed	2 / 89 (2.25%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	2	0	1
BRUISING OF BALL OF R FOOT
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BRUISING OVER RIBS ON RIGHT SIDE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BRUSING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
BURNING HEAD AND RED FACE LASTING 4-5HRS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BURNT RIGHT HAND
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
BURSITIS IN RIGHT FOOT
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
BUZZING IN EARS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CALF CRAMPS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
CARDIAC OTHER - MILD DIZZINESS THOUGHT TO BE MILD HYPOTENSION ALTHOUGH BP NOT MEASURED AT CLINIC
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CATARACT REPAIR LEFT EYE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CATTERACT RIGHT EYE FOLLOWING LASER SURGERY FOR RETINA DETACHMENT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CELLULITIS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CENTRAL CHEST PAIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CENTRAL CHEST PAIN RADIATING TO MID BACK
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CHEST HEAVYNESS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CHEST INFECTION
subjects affected / exposed	10 / 89 (11.24%)	1 / 62 (1.61%)	6 / 107 (5.61%)
occurrences all number	20	1	6
CHEST INFECTION NOS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CHEST INFECTION-DETAILS NOT KNOWN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CHEST PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
CHEST PAIN WITH COLD
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CHEST PAINS AT NIGHT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CHESTY COUGH FROM POST NASAL DRIP
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
CHICKEN POX
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CHILLS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CHRAMP
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CIRCUMORBITAL OEDEMA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
COGNATIVE IMPAIRMENT
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
COLD
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	2
COLD - RUNNY NOSE AND SORE THROAT
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
COLD AND FLU SYMPTOMS
subjects affected / exposed	1 / 89 (1.12%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	1	1	0
COLD AND FLU SYMPTOMS RELATED TO INTERFERON INJECTION
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
COLD AND UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
COLD FINGERS AND TOES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
COLD INTOLERANCE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
COLD SORE
subjects affected / exposed	1 / 89 (1.12%)	2 / 62 (3.23%)	1 / 107 (0.93%)
occurrences all number	1	2	1
COLD SORE ON LOWER LIP
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
COLD SORE UPPER LIP
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
COLD SORES TO NOSE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
COLD SWEATS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
COLD SYMPTOMS
subjects affected / exposed	0 / 89 (0.00%)	2 / 62 (3.23%)	0 / 107 (0.00%)
occurrences all number	0	3	0
COLD VIRUS WITH SINUS DISCHARGE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
COMMON COLD VIRUS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
COMPLAINS OF A REDUCED APPETITE SINCE COMMENCING GLIVEC
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CONJUCTIVITIS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CONJUNCTIVAL INFECTION (RIGHT EYE)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CONJUNCTIVITIS
subjects affected / exposed	0 / 89 (0.00%)	2 / 62 (3.23%)	2 / 107 (1.87%)
occurrences all number	0	2	2
CONSTIPATION
subjects affected / exposed	2 / 89 (2.25%)	1 / 62 (1.61%)	5 / 107 (4.67%)
occurrences all number	2	1	5
CONTINUAL UPSET STOMACH
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CORYZAL SYMPTOMS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
COUGH
subjects affected / exposed	4 / 89 (4.49%)	3 / 62 (4.84%)	2 / 107 (1.87%)
occurrences all number	4	3	2
COUGH AND SORE THROAT
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
COUGH AT NIGHT
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
COUGH WITH SPUTUM
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
COUGH/VIRAL INFECTION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
COVERED IN RASH:HOT AND RED ALL OVER
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
CRAMP
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CRAMP IN HANDS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	0	0	2
CRAMPS
subjects affected / exposed	1 / 89 (1.12%)	4 / 62 (6.45%)	5 / 107 (4.67%)
occurrences all number	1	4	5
CRAMPS HANDS AND LEGS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CRAMPS IN BOTH HANDS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CRAMPS IN BOTH LOWER LEG AREAS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CRAMPS IN CALVES
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CRAMPS IN FEET
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CRAMPS IN FINGERS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CRAMPS IN LEG AND ABDOMEN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CRAMPS IN LEGS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CRAMPS INTERMITTENTLY IN FINGERS AND FEET
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CRAMPS ON CHEST WALL
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
CRAMPS TO KNEE AT NIGHT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CRAMPS, NOT SPECIFIED WHERE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CRAMPS-NOT SPECIFIED
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
CRAMPY ABDOMINAL PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CRAMPY PAIN IN LEGS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
CROHN'S DISEASE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
CROHNS FLARE UP
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CUT OVER LEFT EYE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
CYST ON HEAD
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CYTOPENIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CYTOPENIA LOW BLOOD COUNT PLATELETS 65 HAEMAGLOBIN 7.0
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
CYTOPENIC
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	2
DAY/NIGHT SWEATS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DECREASE IN APPETITE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DECREASED APPETITE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DECREASED NEUTROPHILS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DECREASED PLATELETS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DECRESING NEUTROPHIL COUNT SINCE RECOMMENCING INTERFERON
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DEEP VEIN THROMBOSIS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DEGENERATIVE CHANGES TO LEFT KNEE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DENTAL ABCESS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DENTAL ABCESS LEFT SIDE OF FACE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DEPRESSED
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DEPRESSION
subjects affected / exposed	3 / 89 (3.37%)	6 / 62 (9.68%)	5 / 107 (4.67%)
occurrences all number	3	6	5
DERANGED LIVER FUNCTION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DERANGED LIVER FUNCTION TESTS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DERMATOLOGY/SKIN OTHER: SKIN IRRITATION BUT NO RASH OR FLAKINESS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIABETES TYPE II
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DIAHORREA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	0	0	2
DIARRHEA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIARRHEOA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	0	0	2
DIARRHOEA
subjects affected / exposed	20 / 89 (22.47%)	12 / 62 (19.35%)	29 / 107 (27.10%)
occurrences all number	25	18	49
DIARRHOEA & VOMITING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIARRHOEA & VOMITING.
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIARRHOEA - INTERMITTENT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIARRHOEA AND VOMITING BUG
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIARRHOEA EPISODES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIARRHOEA X2 EPISODES
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DIARRHOEA, NAUSEA AND DIZZINESS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIARRHOEA/NAUSEA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DIARROHEA
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DIFFUSE RASH
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DISCHARGE FROM EARS AND PUFFY EYES
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DISCOLORATION OF TEETH
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIVERTICULITIS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	0	0	3
DIVERTICULITIS (PREVIOUSLY REPORTED)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIZZINESS
subjects affected / exposed	2 / 89 (2.25%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	2	0	3
DIZZINESS/ SPINNING HEAD
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DIZZY
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DIZZYNESS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DROP IN COUNTS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DRY AND ITCHY EYES
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DRY COUGH
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
DRY EYELIDS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DRY EYES
subjects affected / exposed	3 / 89 (3.37%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	3	0	0
DRY LIPS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DRY MOUTH
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DRY MOUTH AND DRY ITCHY SKIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
DRY PENIS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DRY SKIN
subjects affected / exposed	3 / 89 (3.37%)	0 / 62 (0.00%)	4 / 107 (3.74%)
occurrences all number	3	0	4
DRY SKIN TO RIGHT AND LEFT SIDES OF FACE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DRY THROAT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
DRYNESS OF SCALP
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DULL ACHE IN THIGH
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DYSPEPSIA
subjects affected / exposed	0 / 89 (0.00%)	2 / 62 (3.23%)	5 / 107 (4.67%)
occurrences all number	0	2	5
DYSPHAGIA
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
DYSPNEA
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	1 / 107 (0.93%)
occurrences all number	0	1	1
DYSPNOEA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	1	0	2
EAR ACHE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
EAR INFECTION
subjects affected / exposed	3 / 89 (3.37%)	4 / 62 (6.45%)	1 / 107 (0.93%)
occurrences all number	3	4	1
ECZEMA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ECZEMA ON FOREHEAD
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	2
ECZEMA RIGHT AXILLA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ECZEMA TO CALF
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ECZEMATOUS RASH TO LEGS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ECZEMATOUS TYPE LESIONS ON BOTH PALMS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ELEVATED ALT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ELEVATED AST
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	3
ELEVATED BILIRUBIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ELEVATED GAMMA GT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ELEVATED GGT
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ELEVATED LIVER FUNCTION TESTS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
EPIGASTRIC DISCOMFORT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	0	0	2
EPIGASTRIC PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
EPIGASTRIC TENDERNESS
subjects affected / exposed	0 / 89 (0.00%)	2 / 62 (3.23%)	0 / 107 (0.00%)
occurrences all number	0	2	0
EPISODE OF PASSING BLACK STOOLS FOR 4 DAYS (NOT SPECIFIED)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
EPISODES OF CRAMP
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
EPISODES OF CRAMP TO TOES
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
EPISODIC EXPLSIVE DIARRHOEA
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
EPISTAXIS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ERECTILE DYSFUNCTION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ERYTHEMA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ERYTHEMA INJECTION SITE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ERYTHEMA PEGASYS INJECTION SITE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ERYTHEMATOUS CONFLUENT MACULAR RASH
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
EXACERBATION OF DIVERTICULITIS - ABDOMINAL PAIN AND DIARRHOEA
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
EXAMINATION IN PAIN BUT SEEMS VERY OUT OF PROPORTION TO LIKELY SPLENOMEGALY
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
EXCESSIVE PERSPIRATION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
EXCESSIVELY TIRED
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
EXTREMITY LIMB PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
EYE INFECTION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
EYE-WATERING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
EYES BLOOD SHOT
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FACE PAIN - AROUND JAW AREA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FACIAL ODEMA
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	1 / 107 (0.93%)
occurrences all number	0	1	2
FACIAL OEDEMA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FACIAL OEDEMA (PERI-ORBITAL)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FACIAL PUFFINESS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FACIAL RASH
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FACIAL SWELLING
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	2 / 107 (1.87%)
occurrences all number	0	1	3
FACIAL SWELLING AROUND THE EYES
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FACIAL SWELLING IN MORNING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FAINTED
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FALL
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
FALL FROM STAIRS (DISLOCATED RIGHT ELBOW, BROKE 1 RIB)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FATIGUE
subjects affected / exposed	13 / 89 (14.61%)	18 / 62 (29.03%)	24 / 107 (22.43%)
occurrences all number	23	24	32
FATIGUE -POST PEGASYS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FATIGUE/MUSCLE WEAKNESS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FATIGUR
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FATIQUE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FEELING 'COLD'
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FEELING BIT SICKLY AND VOMITED X1
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FEELING COLD
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FEELING HOT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FEELING LETHARGIC
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FEELING MORE MOODY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FEELING MORE TIRED
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FEELING TIRED & UNWELL
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FEELS TIRED & TENDS TO FALL ASLEEP EASILY, NOT GOT THE SAME ENERGY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FEET OEDEMA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FEINT WITH FALL,SORE RIGHT SHOULDER.
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FELT FAINT
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FELT SICK (SOMETIMES VOMIT)
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FEVER
subjects affected / exposed	0 / 89 (0.00%)	2 / 62 (3.23%)	0 / 107 (0.00%)
occurrences all number	0	2	0
FIBROMYALGIA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FINGER INFECTION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FINGER SWELLING
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FLASHING HEADACHES
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FLATULANCE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FLORID ITCHING ERYTHEMATOUS SKIN : TRUNK BACK ARMS AND LEGS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FLORID TOTAL BODY RASH, NON ITCHY
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FLU
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FLU LIKE SYMPTOMS
subjects affected / exposed	1 / 89 (1.12%)	5 / 62 (8.06%)	0 / 107 (0.00%)
occurrences all number	1	5	0
FLU LIKE SYMPTOMS FOLLOWING FIRST PEG INTERFERON INJECTION
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FLU- LIKE SYMPTOMS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FLU-LIKE ILLNESS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FLU-LIKE SYNDROME
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FLUID RETENTION
subjects affected / exposed	1 / 89 (1.12%)	1 / 62 (1.61%)	3 / 107 (2.80%)
occurrences all number	2	1	6
FLUID RETENTION AND WEIGHT GAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FLUID RETENTION TO EYES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FOLLICULAR RASH
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FOLLICULITIS FOREHEAD
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FOLLICULITIS RIGHT ARMPIT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FRACTURED LEFT FIFTH METATARSAL
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FRACTURED LEFT RADIUS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FRACTURED STERUM
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
FRACTURED TIP OF RIGHT LATERAL MALLEOLUS.
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FRESH BLEEDING WHEN OPENING BOWELS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FULLNESS RIGHT BREAST
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
FUNGAL RASH IN PERIANAL AND SCROTAL AREA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
FUNGAL SKIN INFECTION - LEFT SHIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
GALL STONES
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
GALLSTONES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GASTRIC IRRITATION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GASTROENERITIS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
GASTROENTERITIS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
GASTROINTESTINAL SYMPTOMS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
GASTROINTESTINAL UPSET
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GASTROINTESTINAL VIRAL INFECTION
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
GENERAL BODY ACHES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GENERAL MALAISE
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
GENERAL MALISE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
GENERAL WEAKNESS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GENERALISED ACHES AND PAINS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GENERALISED BODY ACHING - MUSCULAR
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GENERALISED BODY RASH
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
GENERALISED ITCH
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GENERALISED PRURITIS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	2	0
GENERALISED RASH
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GENERALISED SKIN RASH
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
GI URGENCY
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
GLOSSAL SWELLING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	2
GOUT
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	1 / 107 (0.93%)
occurrences all number	0	1	1
GOUT IN FINGERS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
GOUT IN LEFT ANKLE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
GRADE 1 MYALGIA, GENERALLY AFFECTING LEGS AND HIP AREAS.
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GRADE 2 TRANSAMINITIS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GRADE 3 HAEM TOXICITY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
GRADE 3 NEUTS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
GRADE 3 TOXICITY AST/ALT RESULTS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GRADE 3 TOXICITY PLATLETS AND NEUTROPHILS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GRADE 3 TOXICITY, NEUTROPHILS 0.3
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GRIPEY ABDOMINAL PAINS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
GRITTINESS AND DISCHARGE FROM EYES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GRITTY EYES
subjects affected / exposed	1 / 89 (1.12%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	1	1	0
GRITTY SKIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
GUM DISEASE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
HAEM TOXICITY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	3	0
HAEM TOXICITY - LOW PLATELATES - PROLONGED MENSES
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
HAEM TOXICITY PLATELETS GRADE 2 TOXICITY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
HAEMATEMESIS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HAEMATOLOGICAL TOXICITY
subjects affected / exposed	0 / 89 (0.00%)	2 / 62 (3.23%)	0 / 107 (0.00%)
occurrences all number	0	3	0
HAEMATOLOGICAL TOXICITY THROMBOCYTOPAENIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HAEMATOLOGICAL TOXICITY WITH A NEUTROPHIL COUNT OF 0.8
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HAEMATOLOGICAL TOXICITY. PLATELETS 46
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HAEMATOMA FOLLOWING BONE MARROW
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
HAEMATUREA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
HAEMATURIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HAEMATURIA (URINE)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HAEMOGLOBIN 80
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HAEMOPTYSIS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HAEMORRHOIDS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
HAIR LOSS
subjects affected / exposed	2 / 89 (2.25%)	2 / 62 (3.23%)	0 / 107 (0.00%)
occurrences all number	2	2	0
HAIR THINNING
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
HALLUCINATIONS FOLLOWING INTERFERON INJECTION
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
HEAD PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
HEADACHE
subjects affected / exposed	1 / 89 (1.12%)	2 / 62 (3.23%)	6 / 107 (5.61%)
occurrences all number	2	2	8
HEADACHES
subjects affected / exposed	7 / 89 (7.87%)	2 / 62 (3.23%)	5 / 107 (4.67%)
occurrences all number	7	2	6
HEADACHES (OCCASIONAL)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HEADACHES AND ACHES AND PAINS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HEARING LOSS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HEARTBURN
subjects affected / exposed	2 / 89 (2.25%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	2	0	2
HEAVY PERIODS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
HEPATIC - RAISED GGT
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
HEPATOTOXICITY
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HERPES SIMPLEX INFECTION
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
HIATUS HERNIA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
HOT AND COLD EPISODES RECENTLY
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
HOT FLUSHES
subjects affected / exposed	1 / 89 (1.12%)	3 / 62 (4.84%)	0 / 107 (0.00%)
occurrences all number	1	3	0
HOT FLUSHES/SWEATS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HYDROCELE/ PLICATION OF HYDROCELE SAC
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HYPERBILIRUBINAEMIA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
HYPERCHOLESTEREAMIA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
HYPERSENSITIVE SKIN REACTION
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
HYPERTENSION
subjects affected / exposed	2 / 89 (2.25%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	2	0	2
HYPOCALCAEMIA
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	1 / 107 (0.93%)
occurrences all number	0	1	1
HYPOKALEMIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HYPOTHYROIDISM
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
HYSTERECTOMY
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INCREASE SWEATS, DAY AND NIGHT
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INCREASED FATIGUE
subjects affected / exposed	2 / 89 (2.25%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	2	0	0
INCREASED MUSCLE WEAKNESS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INDIGESTION
subjects affected / exposed	3 / 89 (3.37%)	0 / 62 (0.00%)	10 / 107 (9.35%)
occurrences all number	4	0	12
INFECTION
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INFECTION (CHEST)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INFECTION - VAGINAL THRUSH
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INFECTION WITH GRADE 1 NEUTROPHILS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INFECTION WITH NORMAL ANC
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INFECTION- BLADDER (URINARY TRACT)
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	3	0
INFLAMMED AND SWOLLEN EYELIDS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INFLAMMED FACE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INFLAMMED RIGHT AND LEFT AXILLA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INFLUENZA
subjects affected / exposed	2 / 89 (2.25%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	2	0	1
INJURY TO RIGHT ELBOW
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INSOMNIA
subjects affected / exposed	3 / 89 (3.37%)	3 / 62 (4.84%)	5 / 107 (4.67%)
occurrences all number	5	3	5
INSPIRATORY CREPITATIONS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INTERMITTANT CRAMPS IN VARIOUS PARTS OF BODY
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INTERMITTANT DIARRHOEA, UNKNOWN ONSET DATE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INTERMITTANT HEADACHES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INTERMITTENT BURNIG SENSATION ON BACK OF HANDS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INTERMITTENT CENTRAL AND LEFT SIDED CHEST PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INTERMITTENT CRAMPS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
INTERMITTENT CRAMPS IN JOINTS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INTERMITTENT DIARRHOEA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
INTERMITTENT HOT FLUSHES
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
INTERMITTENT MUSCLE CRAMPS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INTERMITTENT NAUSEA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
INTERMITTENT VOMITING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
INTERMITTENT VOMITING, MAINLY MORNING.
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
IRON DEFICIENCY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
IRON DEFICIENCY ANAEMIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
IRON DEFICIENT ANAEMIA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
IRREGULAR HEART BEAT - ECG AND ECHO NAD
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
IRRITABLE BOWEL
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
IRRITATION RIGHT EAR
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ITCHING BACK
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ITCHING IN LEFT FOOT
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ITCHING OVER THE SCALP AND LEFT LEG. ASSOCIATED WITH DRY SKIN
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ITCHING,ERYTHEMATOUS LOWER BACK, ARMS AND LEGS
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ITCHY PIMPLES
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
ITCHY RASH
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ITCHY RASH ON LEGS , FACE AND EARLOBES
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ITCHY SKIN
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ITCHY SKIN, DRY AND RED
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ITCHY SPOTS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
ITCHY, RED SKIN, RASH VISIBLE ON ARMS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
ITCY RASH ACROSS CHEST
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
JAUNDICE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
JOINT ACHE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
JOINT PAIN
subjects affected / exposed	3 / 89 (3.37%)	0 / 62 (0.00%)	2 / 107 (1.87%)
occurrences all number	3	0	2
JOINT PAIN (ARTHRALGIA)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
JOINT PAIN R HIP, GROIN AND SHOULDER
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
JOINT PAINS
subjects affected / exposed	1 / 89 (1.12%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	1	1	0
JOINT SWELLING
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
KERATOACANTHOMAS ( ONE SPOT ABOVE LIP)
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
KNEE PAIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LAMINAR MACULAR HOLE LEFT EYE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
LARGE BRUISE TO CHEST
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
LEFT EYE SUBCONJUNCTIVAL HAEMORRHAGE.
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
LEFT GROIN AND HIP PAIN
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
LEFT GROIN PAIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEFT KNEES AND FEET ACHE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
LEFT LEG PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
LEFT LEG SWELLING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEFT RETINAL DETACHMENT. REPAIRED SURGICALLY ON 5/09/2012.
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEFT SHOULDER NERVE PAIN
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEFT SHOULDER PAIN
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
LEFT UPPER QUADRANT DISCOMFORT
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
LEFT UPPER QUADRANT PAIN
subjects affected / exposed	2 / 89 (2.25%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	2	0	0
LEG ACHE, ESPECIALLY IN KNEES
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEG AND ARM CRAMPS
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEG CRAMPS
subjects affected / exposed	7 / 89 (7.87%)	1 / 62 (1.61%)	6 / 107 (5.61%)
occurrences all number	7	1	6
LEG CRAMPS (ON AND OFF) WHEN DRUGS COMMENCED
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEG CRAMPS,
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEG OEDEMA
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
LEG PAIN - SEVERE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEG SWELLING
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
LEGACHE
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	0 / 107 (0.00%)
occurrences all number	1	0	0
LEGS ACHE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LETHAGY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
LETHARGY
subjects affected / exposed	3 / 89 (3.37%)	3 / 62 (4.84%)	6 / 107 (5.61%)
occurrences all number	3	4	7
LETHARGY, MALAISE
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LETHERGY
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
LETHERGY/TIREDNESS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
LEUCOPENIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LEUKOPENIA
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LIGHT HEADED
subjects affected / exposed	1 / 89 (1.12%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	1	0	1
LIGHT HEADED AND UNABLE TO TALK FOR 30 SES. NO TRUE LOC. BACK TO NORMAL WITHIN 2 MINS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
LIGHTHEADED
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LIGHTHEADEDNESS
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number	0	1	0
LIP SWELLING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LIP SWELLING AND TONGUE TIGHTENING
subjects affected / exposed	0 / 89 (0.00%)	0 / 62 (0.00%)	1 / 107 (0.93%)
occurrences all number	0	0	1
LOCAL SKIN REACTION - REDNESS AND SLIGHT SWELLING AT INJECTION SITES
subjects affected / exposed	0 / 89 (0.00%)	1 / 62 (1.61%)	0 / 107 (0.00%)
occurrences all number</

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Phase III, multicentre, open-label, prospective randomised trial comparing Imatinib alone at 400mg versus 800mg daily versus Imatinib 400mg daily plus PEG Interferon-alpha with newly diagnosed chronic myeloid leukaemia

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Overall Survival at 5 Years

Primary: Overall Survival at 5 Years

Secondary: Molecular Response

Secondary: Molecular Response

Secondary: Time to Progression

Secondary: Time to Progression

Secondary: Time to Treatment Failure

Secondary: Time to Treatment Failure

Secondary: Rate of Cytogenetic Response

Secondary: Rate of Cytogenetic Response

Secondary: Complete Haematological Response Rate

Secondary: Complete Haematological Response Rate

Secondary: Tolerability

Secondary: Tolerability

Secondary: Quality of Life

Secondary: Quality of Life

Adverse events

Clinical Trial Results:
Phase III, multicentre, open-label, prospective randomised trial comparing Imatinib alone at 400mg versus 800mg daily versus Imatinib 400mg daily plus PEG Interferon-alpha with newly diagnosed chronic myeloid leukaemia