Table 5.
Summary of adverse events reported by least two subjects in each study
SRD study | |||||||||
---|---|---|---|---|---|---|---|---|---|
PF-04457845 dose | |||||||||
Adverse event | Placebo Cohort 1* (n = 9) | Cohort 2† (n = 12) | 0.1 mg (n = 9) | 0.3 mg (n = 9) | 1 mg (n = 9) | 3 mg (n = 9) | 10 mg (n=9) | 20 mg (n=9) | 40 mg (n=9) |
Number of subjects with adverse events | 2 | 4 | 1 | 1 | 1 | 2 | 4 | 4 | 1 |
Number of subjects with treatment-related adverse events | 0 | 1 | 0 | 0 | 0 | 1 | 2 | 1 | 0 |
Excoriation | 1 (0) | 0 | 1 (0) | 0 | 1 (0) | 0 | 2 (0) | 0 | 0 |
Somnolence | 0 | 1 (1) | 0 | 0 | 0 | 1 (1) | 1 (1) | 0 | 0 |
Eye pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 1 (0) |
Pyrexia | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) |
Arthralgia | 0 | 1 (0) | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 |
Rhinorrhoea | 0 | 1 (0) | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 |
MRD study | |||||
---|---|---|---|---|---|
PF-04457845 dose | |||||
Adverse event | Placebo (n = 8) | 0.5 mg once daily (n = 8) | 1 mg once daily (n = 8) | 4 mg once daily (n = 8) | 8 mg once daily (n = 8) |
Number of subjects with adverse events | 4 | 2 | 3 | 2 | 2 |
Number of subjects with treatment-related adverse events | 4 | 2 | 3 | 2 | 1 |
Faeces hard | 2 (2) | 2 (2) | 2 (2) | 0 | 0 |
Headache | 0 | 2 (2) | 0 | 0 | 1 (1) |
Oropharyngeal pain | 1 (0) | 1 (0) | 0 | 0 | 0 |
Values are numbers of subjects with adverse events (treatment-related adverse events).
Subjects in cohort 1 received placebo, 0.1 mg, 1 mg and 10 mg PF-04457845.
Subjects in cohort 2 received placebo, 0.3 mg, 3 mg, 20 mg and 40 mg PF-04457845.