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Table 3 Summary of On-Therapy Adverse Events: System Organ Class Preferred Term Placebo (N 3) Active (N 3)

This table summarizes adverse events reported by patients during a clinical trial where 3 patients received a placebo and 3 received an active treatment. Gastrointestinal disorders, general disorders, and musculoskeletal disorders were reported in all placebo patients but no active treatment patients. Cardiac disorders and investigations were more commonly reported in active treatment patients. Overall, all patients in both groups reported at least one adverse event.

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114 views2 pages

Table 3 Summary of On-Therapy Adverse Events: System Organ Class Preferred Term Placebo (N 3) Active (N 3)

This table summarizes adverse events reported by patients during a clinical trial where 3 patients received a placebo and 3 received an active treatment. Gastrointestinal disorders, general disorders, and musculoskeletal disorders were reported in all placebo patients but no active treatment patients. Cardiac disorders and investigations were more commonly reported in active treatment patients. Overall, all patients in both groups reported at least one adverse event.

Uploaded by

kranthi633
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as RTF, PDF, TXT or read online on Scribd
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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'.

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