Table 4.
Treatment-Emergent Adverse Events
| Event | Placebo % of Pts (N= 470) | Atrasentan % of Pts (N= 462) | P value † |
|---|---|---|---|
| Any AE | 96.6 | 99.4 | .004 |
|
| |||
| Any AE, grade 3 or 4 | 44.7 | 46.5 | |
|
| |||
| Any SAE | 39.6 | 43.9 | |
|
| |||
| Any SAE resulting in death | 4.7 | 3.5 | |
|
| |||
| Deaths within 30 days of last dose of study drug | |||
| While still receiving study drug | 0.9 | 0.6 | |
| While no longer receiving study drug | 3.8 | 2.6 | |
|
| |||
| AEs resulting in discontinuation | 16.4 | 26.4 | < .001 |
|
| |||
| AEs all grades; incidence of ≥ 15% in either group‡ Preferred term | |||
| Peripheral edema | 21.1 | 49.4 | < .001 |
| Nasal congestion | 11.3 | 39.4 | < .001 |
| Fatigue | 15.1 | 17.7 | |
| Headache | 11.3 | 17.7 | .005 |
| Pain | 18.1 | 16.0 | |
| Back pain | 17.4 | 15.6 | |
| Dyspnea | 9.6 | 15.6 | .007 |
| Hematuria | 16.2 | 14.9 | |
| Constipation | 21.5 | 14.5 | .006 |
| Urinary tract infection | 15.1 | 13.2 | |
| Diarrhea | 15.5 | 12.3 | |
|
| |||
| AEs, grade3 or 4; incidence of ≥ 2% in either group Preferred term | |||
| Obstructive uropathy | 7.2 | 8.2 | |
| Urinary retention | 4.0 | 3.7 | |
| Hematuria | 2.8 | 3.5 | |
| Peripheral edema | 0 | 3.0 | < .001 |
| Anemia | 2.8 | 2.6 | |
| Bladder obstruction | 2.8 | 2.4 | |
| Bone pain | 1.9 | 2.2 | |
| Hydronephrosis | 2.1 | 1.9 | |
| Fracture | 2.8 | 1.5 | |
| Pain | 2.3 | 1.5 | |
| Myocardial infarction | 2.1 | 0.9 | |
| Fall | 2.1 | 0.2 | .011 |
Treatment-emergent adverse events were coded using the Medical Dictionary for Regulatory Activities, version 9.0.
†
P values for pairwise comparisons were determined using the Fisher exact test. If no P value is shown, the difference was not statistically significant.
‡
Anemia and hypertension are not included in the table because the incidence was < 15% in each group (anemia: 7.9%, placebo vs. 12.3%, atrasentan; P = .029, and hypertension: 10.4%, placebo vs. 3.7%, atrasentan; P < .001).