Table 2.
Treatment-related adverse events according to NCI CTC version 4.0 during the TCP/ATRA trial.
| Events | Grade | ||||
|---|---|---|---|---|---|
| I | II | III | IV | ||
| n | n | n | n | n | |
| Non-hematological | |||||
| Vertigo | 7 | 3 | 3 | 1 | 0 |
| Hypotension | 4 | 2 | 1 | 1 | 0 |
| Orthostatic dysregulation/syncope | 4 | 1 | 3 | 0 | 0 |
| Confusion/dizziness | 4 | 0 | 3 | 1 | 0 |
| Skin reaction | 4 | 2 | 2 | 0 | 0 |
| Fatigue | 3 | 0 | 2 | 1 | 0 |
| Xerostomia | 2 | 1 | 1 | 0 | 0 |
| Tinnitus | 2 | 1 | 1 | 0 | 0 |
| Hearing impairmenta | 1 | 0 | 0 | 1 | 0 |
| Vision disorders | 1 | 1 | 0 | 0 | 0 |
| Pain | 1 | 0 | 1 | 0 | 0 |
| Coagulopathya | 1 | 0 | 0 | 1 | 0 |
| Mucositis | 1 | 0 | 0 | 1 | 0 |
| Insomniab | 1 | 0 | 1 | 0 | 0 |
| Muscle twitching | 1 | 0 | 1 | 0 | 0 |
| Myalgia | 1 | 1 | 0 | 0 | 0 |
| Depressiona | 1 | 0 | 0 | 1 | 0 |
| Total number of AEs | 39 | ||||
| Hematological | |||||
| Anemia | 1 | 0 | 0 | 1 | 0 |
| Thrombocytopenia | 1 | 0 | 0 | 0 | 1 |
| Leukocytosisa | 1 | 0 | 1 | 0 | 0 |
| Differentiation syndromea | 1 | 0 | 0 | 1 | 0 |
| Total number of AEs | 4 | ||||
AEs adverse events, NCI CTC National Cancer Institute Common Toxicity Criteria.
aRelated to ATRA.
bRelated to both.