Table 3 Summary of adverse events, serious adverse events and adverse events leading to discontinuation through day 28 (Safety Analysis Population*).
Adverse Event Category | 120 mg/day CEP (N = 104) | 60 mg/day CEP (N = 114) | Placebo (N = 99) |
|---|---|---|---|
Events that emerged during treatment period | |||
No. of adverse events | 48 | 66 | 42 |
Patients with adverse events — no. (%) | |||
Any adverse event | 35(33.65) | 43(37.72) | 35(35.35) |
Serious adverse event | 0(0) | 0(0) | 0(0) |
Maximum grade 3 or 4 adverse event | 0(0) | 0(0) | 0(0) |
Maximum grade 5 adverse event | 0(0) | 0(0) | 0(0) |
Discontinued drug or placebo because of adverse event | 2(1.92) | 4(3.51) | 6(6.06) |
Had dose reduction or temporary discontinuation owing to adverse event | 1(0.96) | 1(0.88) | 1(1.01) |
Adverse Event Type — no. (%) | |||
Diarrhea | 19 (18.27) | 22 (19.30) | 15 (15.15) |
Increased bowel frequency | 9(8.65) | 15 (13.16) | 10 (10.10) |
Drowsiness | 6 (5.77) | 10 (8.77) | 7 (7.07) |
Dizzy | 3 (2.88) | 0 (0) | 1 (1.01) |
Night sweats | 6 (5.77) | 9 (7.89) | 1 (1.01) |
Others | 5 (4.81) | 10 (8.77) | 8 (8.08) |
Events considered to be related to drug or placebo | |||
No. of adverse events | 29 | 31 | 21 |
Patients with adverse events — no. (%) | |||
Any adverse event | 25(24.04) | 27(23.68) | 20(20.20) |
Serious adverse event | 0(0) | 0(0) | 0(0) |
Maximum grade 3 or 4 adverse event | 0(0) | 0(0) | 0(0) |
Maximum grade 5 adverse event | 0(0) | 0(0) | 0(0) |
Discontinued drug or placebo because of adverse event | 2(1.92) | 3(2.63) | 4(4.04) |
Had dose reduction or temporary discontinuation owing to adverse event | 0(0) | 1(0.88) | 1(1.01) |
Adverse Event Type — no. (%) | |||
Diarrhea | 13 (12.50) | 9 (7.89) | 9 (9.09) |
Drowsiness | 6 (5.77) | 10 (8.77) | 7 (7.07) |
Night sweats | 6 (5.77) | 9 (7.89) | 1 (1.01) |
Dizzy | 3 (2.88) | 0 (0) | 1 (1.01) |
Others | 1 (0.96) | 3 (2.63) | 3 (3.03) |
