Table 2.
Adverse Event Categories Where at Least One Grade 4 was Reported* Among Patients Who Received Any Protocol Treatment
| Docetaxel + Placebo (n=486) | Docetaxel + Atrasentan (n=492) | |||||
|---|---|---|---|---|---|---|
| Grade | Grade | |||||
| Adverse event | ≤3 | 4 | 5 | ≤3 | 4 | 5 |
| Allergy/Immunology | 486 | 0 | 0 | 491 | 1 | 0 |
| Blood/Bone Marrow | 396 | 90 | 0 | 405 | 87 | 0 |
| Cardiac Arrhythmia | 485 | 1 | 0 | 491 | 1 | 0 |
| Cardiac General | 482 | 3 | 1 | 489 | 3 | 0 |
| Constitutional symptoms | 481 | 5 | 0 | 491 | 1 | 0 |
| Dermatogical | 484 | 0 | 2 | 492 | 0 | 0 |
| Gastrointestinal | 485 | 1 | 0 | 490 | 2 | 0 |
| Hemorrhage/Bleeding | 485 | 1 | 0 | 491 | 0 | 1 |
| Infection | 478 | 7 | 1 | 485 | 5 | 2 |
| Metabolic/Laboratory | 479 | 7 | 0 | 487 | 5 | 0 |
| Musculoskeletal/Soft Tissue | 485 | 1 | 0 | 492 | 0 | 0 |
| Neurology | 484 | 2 | 0 | 491 | 1 | 0 |
| Pain | 486 | 0 | 0 | 491 | 1 | 0 |
| Pulmonary/Upper Respiratory | 473 | 10 | 3 | 490 | 2 | 0 |
| Renal/Genitourinary | 485 | 1 | 0 | 492 | 0 | 0 |
| Vascular | 481 | 5 | 0 | 485 | 7 | 0 |
*
Treatment attribution: possible, probable, or definite, No Grade 5 reported
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For all patients, including all AE categories.