Table 2

Dose-limiting toxicity of fish oil ethyl ester soft gelatin capsules

No. of patients
Dose level (g/kg/day)EnteredDLTaDLT event
0.1020
0.1531 (33%)bGrade 3 diarrhea/fecal incontinence of oil
0.2041 (25%)Grade 3 diarrhea/cramping
0.2571 (14%)Grade 3 nausea/vomiting
0.30 c 7 1 (14%) Unable to tolerate in stomach/esophagusd
0.3563 (50%)Oily stools/diarrhea; oily stools/diarrhea; Unable to tolerate in stomach/esophagus
0.4031 (33%)Unable to tolerate in stomach/esophagus
0.4531 (33%)Grade 3 diarrhea/fecal incontinence
0.5022 (100%)Grade 3 diarrhea
Grade 3 diarrhea/oily stools
  • a Dose-limiting toxicity.

  • b Patient later tolerated same dose without toxicity.

  • c Maximal tolerated dose in bold.

  • d Defined in “Patients and Methods.”