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Table 4 Summary of adverse events causally related to treatment with AZD9164

From: Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies

 

AEs assessed as causally-related to AZD9164

 

Placebo

AZD9164

 

GMAD, healthy subjects

n = 9

400 μg

1000 μg

2800 μg

Total (%)

  

n = 6

n = 6

n = 6

n = 27

Dry mouth

0

  

1 (16.7)

1 (3.7)

Throat irritation

0

  

3 (50.0)

3 (11.1)

Cough

0

  

2 (33.3)

2 (7.4)

Flushing

0

  

1 (16.7)

1 (3.7)

JMAD, healthy subjects

n = 6

400 μg

1000 μg

 

Total (%)

  

n = 6

n = 6

 

n = 18

Rash

0

1 (16.7)

  

1 (5.6)

Headache

0

1 (16.7)

  

1 (5.6)

Cough

0

1 (16.7)

1 (16.7)

 

2 (11.1)

Upper respiratory tract infection

0

1 (16.7)

0

 

1 (5.6)

Respiratory tract irritation

0

 

1 (16.7)

 

1 (5.6)

Epistaxis

0

 

1 (16.7)

 

1 (5.6)

Nasal mucosal disorder

0

 

1 (16.7)

 

1 (5.6)

GMAD, COPD patients

n = 1

 

n = 3

 

n = 4

Dry mouth

0

 

1 (33.3)

 

1 (25.0)

Palpitations

0

 

1 (33.3)

 

1 (25.0)

Anxiety

0

 

1 (33.3)

 

1 (25.0)

Dyspnoea

0

 

2 (66.6)

 

2 (50.0)

Cough

0

 

1 (33.3)

 

1 (25.0)

Haematoma

0

 

1 (33.3)

 

1 (25.0)

Fatigue

0

 

1 (33.3)

 

1 (25.0)