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Table 3 Summary of Adverse Drug Reactions (ADR)

From: High strength extrafine pMDI beclometasone/formoterol (200/6 μg) is effective in asthma patients not adequately controlled on medium-high dose of inhaled corticosteroids

 

BDP/FF

N = 189

BDP

N = 180

 

Number of patients (%)

Number of events

Number of patients (%)

Number of events

Any ADR

2 (1.1)

3

5 (2.8)

5

Respiratory, thoracic and mediastinal disorders

0 (0.0)

0

3 (1.7)

3

Asthma

0 (0.0)

0

1 (0.6)

1

Dysphonia

0 (0.0)

0

1 (0.6)

1

Throat irritation

0 (0.0)

0

1 (0.6)

1

Skin and subcutaneous tissue disorders

1 (0.5)

1

1 (0.6)

1

Acne

1 (0.5)

1

0 (0.0)

0

Dermatitis contact

0 (0.0)

0

1 (0.6)

1

Gastrointestinal disorders

0 (0.0)

0

1 (0.6)

1

Nausea

0 (0.0)

0

1 (0.6)

1

General disorders and administration site conditions

1 (0.5)

1

0 (0.0)

0

Chest discomfort

1 (0.5)

1

0 (0.0)

0

Infections and infestations

1 (0.5)

1

0 (0.0)

0

Oral candidiasis

1 (0.5)

1

0 (0.0)

0