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Table 3 Summary of On-therapy Adverse Events

System Organ Class


Preferred Term

Placebo Active
(N=3) (N=3)

Patients Any Ae

3(100)

3(100)

CARDIAC DISORDERS

2(66.7)

1(33.3)

Atrial Fibrillation

0(0)

1(33.3)

Palpitations

1(33.3)

0(0)

Supraventricular Extrasystoles

1(33.3)

0(0)

GASTROINTESTINAL DISORDERS

3(100)

0(0)

Colitis Ulcerative

1(33.3)

0(0)

Diarrhoea

1(33.3)

0(0)

Flatulence

1(33.3)

0(0)

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

3(100)

0(0)

Chest Pain

1(33.3)

0(0)

Oedema Peripheral

2(66.7)

0(0)

INFECTIONS AND INFESTATIONS

1(33.3)

0(0)

Viral Infection

1(33.3)

0(0)

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

1(33.3)

1(33.3)

Chemical Burn Of Skin

1(33.3)

0(0)

Thermal Burn

0(0)

1(33.3)

INVESTIGATIONS

1(33.3)

3(100)

Blood Pressure Increased

1(33.3)

1(33.3)

Electrocardiogram Low Voltage

0(0)

1(33.3)

Qrs Axis Abnormal

0(0)

1(33.3)

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

3(100)

2(66.7)

Arthralgia

2(66.7)

1(33.3)

Muscle Strain

1(33.3)

0(0)

Psoriatic Arthropathy

0(0)

1(33.3)

NERVOUS SYSTEM DISORDERS

1(33.3)

0(0)

Insomnia

1(33.3)

0(0)

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

4(133.3) 2(66.7)

Cough

1(33.3)

0(0)

Dyspnoea

1(33.3)

0(0)

Nasopharyngitis

1(33.3)

1(33.3)

Rhonchi

0(0)

1(33.3)

Upper Respiratory Tract Infection

1(33.3)

0(0)

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

0(0)

2(66.7)

02:45 Friday, June 05, 2015 1

Programming notes:
The percentages, mean, and the standard deviations should be calculated using little 'n'.

Table 3 Summary of On-therapy Adverse Events


Pruritus

0(0)

1(33.3)

Psoriasis

0(0)

1(33.3)

VASCULAR DISORDERS

1(33.3)

1(33.3)

Hypertension

1(33.3)

1(33.3)

02:45 Friday, June 05, 2015 2

Programming notes:
The percentages, mean, and the standard deviations should be calculated using little 'n'.