Adverse event | Patients, N (%) | ||||
---|---|---|---|---|---|
Placebo | PH-797804 | ||||
0.5 mg | 3 mg | 6 mg | 10 mg | ||
Patients (N) | 45 | 20 | 47 | 70 | 48 |
Patients with adverse events (N) | 17 (38) | 4 (20) | 19 (40) | 37 (53) | 23 (48) |
COPD exacerbation | 5 (11) | 0 | 3 (6) | 1 (1) | 6 (13) |
Rash* | 1 (2) | 1 (5) | 3 (6) | 9 (13) | 1 (2) |
Nasopharyngitis | 2 (4) | 0 | 5 (11) | 3 (4) | 0 |
Diarrhoea | 0 | 0 | 1 (2) | 3 (4) | 2 (4) |
Headache | 1 (2) | 0 | 0 | 5 (7) | 0 |
Tremor | 0 | 0 | 0 | 1 (1) | 4 (8) |
Pharyngitis | 1 (2) | 0 | 0 | 2 (3) | 1 (2) |
Urinary tract infection | 1 (2) | 0 | 0 | 1 (1) | 2 (4) |
Increased ALT† | 0 | 0 | 1 (2) | 1 (1) | 2 (4) |
Dizziness | 2 (4) | 0 | 0 | 0 | 1 (2) |
Dyspepsia | 1 (2) | 0 | 0 | 2 (3) | 0 |
Fatigue | 0 | 0 | 0 | 0 | 2 (4) |
Nausea | 0 | 0 | 0 | 2 (3) | 1 (2) |
Arthralgia | 0 | 0 | 0 | 2 (3) | 0 |
Left bundle branch block | 0 | 0 | 0 | 2 (3) | 0 |
Right bundle branch block | 0 | 0 | 0 | 2 (3) | 0 |
Chest pain | 0 | 0 | 0 | 0 | 2 (4) |
Dry skin | 0 | 0 | 0 | 2 (3) | 0 |
Syncope | 0 | 0 | 0 | 2 (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.