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. 2011 Nov 1;73(5):706–716. doi: 10.1111/j.1365-2125.2011.04137.x

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.

HHS Vulnerability Disclosure