Table 3 Summary of adverse events
Event, n (%) | Total | < 75 years | ≥ 75 years | P value |
|---|---|---|---|---|
(n = 271) | (n = 199) | (n = 72) | ||
Any AEs | 48 (17.7) | 35 (17.6) | 13 (18.1) | 0.927 |
Fatal AEs | 0 | 0 | 0 | |
AEs leading to treatment discontinuation | 4 (1.5) | 4 (2) | 0 | 0.521 |
Pruritus | 22 (8.1) | 16 (8) | 6 (8.3) | 0.862 |
Headache | 6 (2.2) | 6 (3) | 0 | 0.306 |
Fatigue | 4 (1.5) | 3 (1.5) | 1 (1.4) | 0.618 |
Nausea | 3 (1.1) | 2 (1) | 1 (1.4) | 0.696 |
Skin eruption | 2 (0.7) | 2 (1) | 0 | 0.959 |
Palpitation | 1 (0.4) | 1 (0.5) | 0 | 0.595 |
Abdominal pain | 2 (0.7) | 2 (1) | 0 | 0.959 |
Sleepiness | 1 (0.4) | 1 (0.5) | 0 | 0.595 |
Hypertension | 1 (0.4) | 1 (0.5) | 0 | 0.595 |
Pyelonephritis | 1 (0.4) | 1 (0.5) | 0 | 0.595 |
Epigastric discomfort | 1 (0.4) | 0 | 1 (1.4) | 0.595 |
Feverish illness | 1 (0.4) | 0 | 1 (1.4) | 0.595 |
Head congestion | 1 (0.4) | 0 | 1 (1.4) | 0.595 |
Cold-like symptoms | 1 (0.4) | 1 (0.5) | 0 | 0.595 |
Dyspnea | 1 (0.4) | 1 (0.5) | 0 | 0.595 |
Laboratory abnormalities | ||||
Elevation of total bilirubin | 4 (1.5) | 1 (0.5) | 3 (4.2) | 0.101 |
Elevation of indirect bilirubin | 1 (0.4) | 1 (0.5) | 0 | 0.595 |
Elevation of alanine aminotransferase | 5 (1.8) | 3 (1.5) | 2 (2.8) | 0.861 |
Elevation of alkaline phosphatase | 2 (0.7) | 1 (0.5) | 1 (1.3) | 0.960 |
Elevation of creatinine | 1 (0.4) | 1 (0.5) | 0 | 0.595 |