Table 2.

Percentage of subjects with worst grade of adverse event for CTCAE v3 category

CTCAE categoryGradePlacebo (%)300 mg (%)600 mg (%)
Overalla0None7 (35)2 (10)3 (15)
1Mild10 (50)14 (70)11 (55)
2Moderate1 (5)2 (10)5 (25)
3Severe1 (5)2 (10)1 (5)
4Life-threatening1 (5)0 (0)0 (0)
Metabolic/laboratory0None5 (25)7 (35)7 (35)
1Mild13 (65)11 (55)11 (55)
2Moderate1 (5)0 (0)2 (10)
3Severe1 (5)2 (10)0 (0)
4Life-threatening0 (0)0 (0)0 (0)
Gastrointestinal0None16 (80)17 (85)16 (80)
1Mild4 (20)2 (10)2 (10)
2Moderate0 (0)1 (5)1 (5)
3Severe0 (0)0 (0)1 (5)
4Life-threatening0 (0)0 (0)0 (0)

NOTE: Includes categories where at least one grade II or worse event occurred in a non-placebo arm.

  • ↵aP = 0.12; Jonckheere–Terpstra test.