Table 3.

Patients with adverse events considered to be related^* to fluticasone/formoterol (observed in more than two patients; safety population).

System organ class Preferred term	Total (n = 2539)
Cardiac disorders, n (%)
Palpitations	14 (0.6)
Tachycardia	7 (0.3)
Gastrointestinal disorders, n (%)
Dry mouth	4 (0.2)
Dyspepsia	3 (0.1)
Nausea	6 (0.2)
General disorders, n (%)
Chest discomfort	5 (0.2)
Infections and infestations, n (%)
Bronchopneumonia	3 (0.1)
Lower respiratory tract infection	7 (0.3)
Nasopharyngitis	3 (0.1)
Oral candidiasis	17 (0.7)
Oral fungal infection	4 (0.2)
Oropharyngeal candidiasis	3 (0.1)
Respiratory tract infection	3 (0.1)
Upper respiratory tract infection	4 (0.2)
Musculoskeletal and connective tissue disorders, n (%)
Back pain	3 (0.1)
Muscle spasms	7 (0.3)
Nervous system disorders, n (%)
Dizziness	3 (0.1)
Headache	10 (0.4)
Tremor	16 (0.6)
Respiratory, thoracic and mediastinal disorders, n (%)
Asthma	50 (2.0)
Cough	28 (1.1)
Dysphonia	46 (1.8)
Dyspnoea	5 (0.2)
Oropharyngeal pain	13 (0.5)
Upper-airway cough syndrome	3 (0.1)
Vascular disorders, n (%)
Hypertension	3 (0.1)

^*Investigator considered reasonable possibility of causal relationship to investigational medicinal product.

A patient may have more than one adverse event in any category. Highest causal relationship to study medication is counted if an adverse event is reported more than once by the same subject. Adverse events were coded using MedDRA version 16.0 (March 2013, MedDRA MSSO, McLean, VA, USA).