Table 3.
Summary of patients experiencing SAEs during the treatment period*
| Available information on SAEs | No. of patients (%) | |
|---|---|---|
| Fulvestrant 500mg (n = 361) | Fulvestrant 250mg (n = 374) | |
| Patients with at least 1 SAE during the whole trial | ||
| Any SAE | 35 (9.7) | 27 (7.2) |
| Any SAE with outcome other than death† | 32 (8.9) | 22 (5.9) |
| Any causally related SAE | 8 (2.2) | 4 (1.1) |
| SAEs occurring in >1 patient | ||
| Acute myocardial infarction | 0 (0) | 2 (0.5) |
| Anemia | 3 (0.8) | 1 (0.3) |
| Bronchitis | 2 (0.6) | 0 (0) |
| Dyspnea | 2 (0.6) | 1 (0.3) |
| Femur fracture | 1 (0.3) | 2 (0.5) |
| Hyperglycemia | 2 (0.6) | 0 (0) |
| Pneumonia | 2 (0.6) | 0 (0) |
| Vomiting | 2 (0.6) | 1 (0.3) |
| SAEs with outcome of death, preferred term | ||
| Acute myocardial infarction | 0 (0) | 2 (0.5) |
| Acute renal failure | 0 (0) | 1 (0.3) |
| Aspiration | 0 (0) | 1 (0.3) |
| Cardiopulmonary failure | 1 (0.3) | 0 (0) |
| Suicide | 0 (0) | 1 (0.3) |
| Death, cause unknown | 1 (0.3) | 0 (0) |
| Dyspnea | 2 (0.6) | 0 (0) |
| Hypertension | 0 (0) | 1 (0.3) |
| Intestinal adenocarcinoma | 1 (0.3) | 0 (0) |
| Meningitis | 0 (0) | 1 (0.3) |
* SAEs = serious adverse events.
† All patients experiencing an SAE with nonfatal outcome (regardless of whether they later had a fatal SAE).