Research Article
NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors
Table 2
(a) Overall hematologic CTCAE adverse events (
). (b) Most common nonhematologic CTCAE adverse events (
).
(a) |
| Hematologic adverse events |
Number of events (possibly multiple events from same participant) |
Number of participants experiencing (multiple) events |
Number of participants (with most severe event if there are multiple) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
| Lymphopenia | 42 | 105 | 51 | 2 | 200 | 34 | | 15 | 17 | 2 | Anemia | 85 | 61 | 12 | | 158 | 41 | 13 | 22 | 6 | | Leukopenia (Total WBC) | 83 | 50 | 16 | | 149 | 30 | 8 | 12 | 10 | | Thrombocytopenia | 78 | 13 | 7 | 2 | 100 | 29 | 20 | 4 | 3 | 2 | Neutropenia (ANC/AGC) | 41 | 39 | 18 | 1 | 99 | 26 | 4 | 11 | 10 | 1 | Total hematologic AEs | 329 | 268 | 104 | 5 | 706 | | | | | |
|
|
(b) |
| Nonhematologic adverse events |
Number of events (possibly multiple events from same participant) |
Number of participants experiencing (multiple) events |
Number of participants (with most severe event if there are multiple) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
| Hyperglycemia | 81 | 35 | 8 | | 124 | 34 | 17 | 12 | 5 | | Hypoalbuminemia | 53 | 38 | 2 | | 93 | 29 | 11 | 16 | 2 | | Hypocalcemia | 59 | 19 | 1 | | 79 | 33 | 20 | 12 | 1 | | Hyponatremia | 50 | 0 | 9 | 1 | 60 | 29 | 22 | 0 | 6 | 1 | Elevated AST, SGOT | 42 | 13 | 2 | | 57 | 30 | 20 | 8 | 2 | | Elevated ALP, ALKP | 29 | 22 | 5 | | 56 | 25 | 10 | 10 | 5 | | Nausea | 27 | 23 | 1 | | 51 | 24 | 9 | 14 | 1 | | Fatigue | 20 | 25 | 5 | | 50 | 29 | 7 | 17 | 5 | | Total: most commonly occurring nonheme AEs | 361 | 175 | 33 | 1 | 570 | | 116 | 89 | 27 | 1 | Total: nonheme AEs (overall) | 751 | 398 | 85 | 6 | 1243 | | | | | |
|
|