Table 4B.

Frequency of adverse events by patient study arm

Adverse eventsDFMO + aspirin (n = 53)Placebo (n = 51)
All grade ≥ 304 (7.8%)
Nonhematologic, grade ≥ 302 (3.9%)
Any AE10 (18.8%)8 (15.6%)
Cardiovascular00
Gastrointestinal1 (1.9%)0
Abdominal pain01 (2%)
Diarrhea01 (2%)
Tinnitus2 (3.8%)4 (7.8%)
Abnormal audiogram1 (1.9%)1 (2%)
Headache1 (1.9%)1 (2%)
Dizziness1 (1.9%)0
Nausea01 (2%)
Musculoskeletal disorder1 (1.9%)0
Pain1 (1.9%)0
Rectal hemorrhage1 (1.9%)0
Rectal pain1 (1.9%)0