Table 4A.

Adverse event grade by study arm in the overall population

Adverse EventGrade
TypeArm1234
n (%)n (%)n (%)n (%)
TinnitusPlacebo3 (5.9)1 (2.0)
DFMO + ASA2 (3.8)
HeadachePlacebo1 (2.0)
DFMO + ASA1 (1.9)
Abnormal audiogramPlacebo1 (2.0)
DFMO + ASA1 (1.9)
Abdominal painPlacebo1 (2.0)
DiarrheaPlacebo1 (2.0)
DizzinessDFMO + ASA1 (1.9)
Gastrointestinal disorderDFMO + ASA1 (1.9)
Musculoskeletal disorderDFMO + ASA1 (1.9)
NauseaPlacebo1 (2.0)
PainDFMO + ASA1 (1.9)
Rectal hemorrhageDFMO + ASA1 (1.9)
Rectal painDFMO + ASA1 (1.9)
  • NOTE: Total N = 104; DFMO + aspirin, n = 53; double placebo, n = 51.