Table 2.
Overall Safety Summary and Frequent TEAEs for the Placebo-Controlled Cohort and the All-Difelikefalin-Exposure Cohort
| Placebo-Controlled Cohort |
All-Difelikefalin-Exposure Cohort |
|||||
|---|---|---|---|---|---|---|
| Placebo n = 424 101.1 PY |
Difelikefalin n = 424 98.0 PY |
Difelikefalin n = 1,306 811.3 PY |
||||
| n (%) | IR/1,000 PY | n (%) | IR/1,000 PY | n (%) | IR/1,000 PY | |
| Overview of TEAEs | ||||||
| ≥1 TEAE | 277 (65.3) | 9,597.8 | 302 (71.2) | 10,862.9 | 1,022 (78.3) | 8,115.5 |
| ≥1 Nonfatal, serious TEAE | 96 (22.6) | 1,860.2 | 107 (25.2) | 2,040.0 | 542 (41.5) | 1,824.3 |
| AEs leading to death | 5 (1.2) | 49.5 | 3 (0.7) | 30.6 | 56 (4.3) | 69.0 |
| TEAEs leading to discontinuation | 17 (4.0) | 395.8 | 29 (6.8) | 428.4 | 121 (9.3) | 196.0 |
| Commonly reported TEAEsa | ||||||
| Diarrhea | 24 (5.7) | 267.2 | 38 (9.0) | 469.2 | 158 (12.1) | 266.2 |
| Dizziness | 16 (3.8) | 188.0 | 29 (6.8) | 316.2 | 103 (7.9) | 151.6 |
| Nausea | 19 (4.5) | 207.8 | 28 (6.6) | 326.4 | 147 (11.3) | 225.6 |
| Gait disturbancesb | 23 (5.4) | 237.5 | 28 (6.6) | 336.6 | 152 (11.6) | 267.5 |
| Hyperkalemia | 15 (3.5) | 158.3 | 20 (4.7) | 234.6 | 108 (8.3) | 157.8 |
| Headache | 11 (2.6) | 118.7 | 19 (4.5) | 214.2 | 78 (6.0) | 106.0 |
| Somnolence | 10 (2.4) | 98.9 | 18 (4.2) | 204.0 | 29 (2.2) | 39.4 |
| Mental status changec | 6 (1.4) | 59.4 | 14 (3.3) | 142.8 | 58 (4.4) | 80.1 |
Note: IR is calculated as 1,000 times the number of events divided by the total patient-years of exposure.
Abbreviations: AE, adverse event; IR, incidence rate; PY, person-year; TEAE, treatment-emergent adverse event.
a
Preferred terms of TEAEs reported in ≥2% of difelikefalin participants with an incidence ≥1 percentage point higher than in placebo participants.
b
Gait disturbances include preferred terms of falls and gait disturbances.
c
Mental status change includes preferred terms of confusional state and mental status change.