Table 6

All-cause treatment-emergent adverse events in at least two patients in any treatment group

Adverse eventPatients, N (%)
PlaceboPH-797804
0.5 mg3 mg6 mg10 mg
Patients (N)4520477048
Patients with adverse events (N)17 (38)4 (20)19 (40)37 (53)23 (48)
COPD exacerbation5 (11)03 (6)1 (1)6 (13)
Rash*1 (2)1 (5)3 (6)9 (13)1 (2)
Nasopharyngitis2 (4)05 (11)3 (4)0
Diarrhoea001 (2)3 (4)2 (4)
Headache1 (2)005 (7)0
Tremor0001 (1)4 (8)
Pharyngitis1 (2)002 (3)1 (2)
Urinary tract infection1 (2)001 (1)2 (4)
Increased ALT†001 (2)1 (1)2 (4)
Dizziness2 (4)0001 (2)
Dyspepsia1 (2)002 (3)0
Fatigue00002 (4)
Nausea0002 (3)1 (2)
Arthralgia0002 (3)0
Left bundle branch block0002 (3)0
Right bundle branch block0002 (3)0
Chest pain00002 (4)
Dry skin0002 (3)0
Syncope0002 (3)0
  • If the same patient in a given treatment had more than one occurrence in the same preferred term event category (or more than one of the rash terms in the combined category), the patient was only counted once per treatment group.

  • Data are from the safety analysis set.

  • *Rash includes the following terms: rash, rash generalised, rash macular, rash pustular, dermatitis, dermatitis acneiform and pruritus.

  • †The maximum ALT increase was less than twice the upper limit of normal range.

  • ALT, alanine aminotransferase; COPD, chronic obstructive pulmonary disease.