Table 2. Adverse event frequency by type and severity level in the two treatment arms (Gordon et al, 2001; Smith et al, 2002).
| Adverse event type | Grade | PLD n (%) | Topotecan n (%) |
|---|---|---|---|
| Anemia | Total | 319 (100) | 985 (100) |
| Grade I | 199 (62) | 363 (37) | |
| Grade II | 101 (32) | 476 (48) | |
| Grade III | 18 (6) | 134 (14) | |
| Grade IV | 1 (0) | 12 (1) | |
| Thrombocytopenia | Total | 71 (100) | 944 (100) |
| Grade I | 54 (76) | 434 (46) | |
| Grade II | 14 (20) | 272 (29) | |
| Grade III | 3 (4) | 175 (19) | |
| Grade IV | 0 (0) | 63 (7) | |
| Neutropenia | Total | 311 (100) | 1438 (100) |
| Grade I | 153 (48) | 296 (20) | |
| Grade II | 105 (35) | 378 (26) | |
| Grade III | 42 (14) | 427 (30) | |
| Grade IV | 11 (3) | 337 (24) | |
| Sepsis | Total | 4 (100) | 17 (100) |
| Grade I | 0 (0) | 0 (0) | |
| Grade II | 1 (25) | 5 (35) | |
| Grade III | 3 (75) | 3 (15) | |
| Grade IV | 0 (0) | 9 (50) | |
| Fever | Total | 69 (100) | 65 (100) |
| Grade I | 36 (55) | 31 (48) | |
| Grade II | 26 (42) | 20 (31) | |
| Grade III | 2 (3) | 8 (12) | |
| Grade IV | 0 (0) | 5 (9) | |
| Stomatitis/Pharyngitis | Total | 378 (100) | 130 (100) |
| Grade I | 202 (53) | 91 (70) | |
| Grade II | 144 (38) | 37 (28) | |
| Grade III | 31 (8) | 2 (2) | |
| Grade IV | 1 (0) | 0 (0) | |
| Nausea/Vomiting | Total | 386 (100) | 567 (100) |
| Grade I | 236 (61) | 333 (59) | |
| Grade II | 110 (28) | 175 (31) | |
| Grade III | 37 (10) | 51 (9) | |
| Grade IV | 3 (1) | 8 (1) | |
| Diarrhoea | Total | 74 (100) | 126 (100) |
| Grade I | 42 (57) | 68 (54) | |
| Grade II | 26 (35) | 47 (37) | |
| Grade III | 5 (7) | 10 (8) | |
| Grade IV | 1 (1) | 1 (1) | |
| PPE | Total | 379 (100) | 2 (100) |
| Grade I | 195 (51) | 2 (100) | |
| Grade II | 120 (32) | 0 (0) | |
| Grade III | 62 (16) | 0 (0) | |
| Grade IV | 2 (1) | 0 (0) | |
PLD=pegylated liposomal doxorubicin hydrochloride; PPE=palmar-plantar erythrodysesthesia.