TABLE 4.
Overview of dosing status, TEAEs and deaths a per 100 patient‐years
| Enzalutamide Cohort 1: chemotherapy naïve + abiraterone naïve (n = 1175) | Enzalutamide Cohort 2: postchemotherapy + abiraterone naïve (n = 418) | |
|---|---|---|
| Treatment duration, median, days (IQR) | 372.0 (167‐533) | 253.0 (117‐509) |
| Dosing status per patient b | ||
| Dose modifications | 132 (11.2) | 29 (6.9) |
| Dose interruptions | 107 (9.1) | 24 (5.7) |
| n (%) | IR c | n (%) | IR c | |
|---|---|---|---|---|
| TEAEs | 599 (51.0) | 178.0 | 260 (62.2) | 292.9 |
| Treatment‐related TEAEs | 321 (27.3) | 52.6 | 113 (27.0) | 66.8 |
| Serious TEAEs | 236 (20.1) | 33.9 | 116 (27.8) | 53.4 |
| Serious treatment‐related TEAEs | 39 (3.3) | 4.1 | 17 (4.1) | 6.1 |
| TEAEs leading to treatment discontinuation | 247 (21.0) | 24.2 | 84 (20.1) | 25.9 |
| Treatment‐related TEAEs leading to treatment discontinuation | 122 (10.4) | 12.7 | 26 (6.2) | 8.6 |
| Deaths a | 91 (7.7) | 7.5 | 29 (6.9) | 8.1 |
| Most frequently reported TEAEs (in ≥5% of patients in any cohort) d | ||||
| Fatigue | 170 (14.5) | 15.7 | 60 (14.4) | 17.2 |
| Back pain | 79 (6.7) | 6.9 | 36 (8.6) | 10.6 |
| Asthenia | 77 (6.6) | 8.5 | 39 (9.3) | 12.2 |
| Decreased appetite | 68 (5.8) | 5.7 | 26 (6.2) | 7.5 |
| Malignant neoplasm progression | 61 (5.2) | 5.1 | 34 (8.1) | 9.5 |
| Hot flush | 60 (5.1) | 5.0 | 25 (6.0) | 7.0 |
| Nausea | 46 (3.9) | 4.2 | 30 (7.2) | 8.6 |
| Constipation | 43 (3.7) | 3.7 | 21 (5.0) | 6.1 |
| Bone pain | 42 (3.6) | 4.1 | 38 (9.1) | 11.7 |
| Arthralgia | 41 (3.5) | 4.0 | 26 (6.2) | 8.1 |
| General physical health deterioration | 30 (2.6) | 2.7 | 16 (3.8) | 4.7 |
| Anemia | 25 (2.1) | 3.0 | 25 (6.0) | 12.8 |
Note: Data presented as n (%) unless otherwise stated. Data from SAF (n = 1732).
Abbreviation: IQR, interquartile range; IR, incidence rate.
a
TEAEs and deaths were reported from the time of consent until 30 days following enzalutamide treatment discontinuation.
b
Patients can be counted in both dose changes and dose interruptions but will only count a maximum of once in each.
c
The IR, or the number of TEAEs per 100 patient‐years, is calculated as the number of TEAEs × 100, divided by the sum of treatment‐emergent period duration of all patients treated in the corresponding cohort in years.
d
TEAEs were sorted by frequency in Cohort 1, as this was the largest group.