Table 2.
Grade 3 or Higher Toxicities by Treatment Arm
| Toxicity Type | Tamoxifen Alone (n = 171) Grade |
Tamoxifen + OFS (n = 174) Grade |
||||||
|---|---|---|---|---|---|---|---|---|
| 3 |
4 |
3 |
4 |
|||||
| No. | % | No. | % | No. | % | No. | % | |
| Hot flashes | 8 | 4.7 | — | 28 | 16.1 | — | ||
| Neuropsychiatric* | 2 | 1.2 | 2 | 1.2 | 4 | 2.3 | — | |
| Neuroclinical† | 1 | 0.6 | — | 4 | 2.3 | — | ||
| Allergy | — | — | 1 | 0.6 | — | |||
| Weight gain | 4 | 2.3 | — | 6 | 3.4 | — | ||
| Vaginal dryness | — | — | 1 | 0.6 | — | |||
| Changes in libido | — | — | 1 | 0.6 | — | |||
| Anemia | — | — | — | 1 | 0.6 | |||
| Clotting disorders | — | — | 1 | 0.6 | — | |||
| Itching | 1 | 0.6 | — | — | — | |||
| Night sweats | — | — | 1 | 0.6 | — | |||
| Dizziness | 1 | 0.6 | — | — | — | |||
| Liver | — | — | 1 | 0.6 | — | |||
| Edema | — | — | 1 | 0.6 | — | |||
| Hypoglycemia | — | — | 1 | 0.6 | — | |||
| Pain | — | — | 1 | 0.6 | — | |||
| Insomnia | 2 | 1.2 | — | — | — | |||
| Endometriosis | 1 | 0.6 | — | — | — | |||
| Amenorrhea | 1 | 0.6 | — | — | — | |||
| Hypertension | — | — | 1 | 0.6 | — | |||
| Highest grade | 16 | 11.1 | 2 | 1.2 | 38 | 21.8 | 1 | 0.6 |
Abbreviation: OFS, ovarian function suppression.
*
Included anxiety and depression.
†
Included somnolence; confusion; hallucinations; coordination issues such as tremors, nystagmus, ataxaia, and dysdiadokinesis; and headache.