Table 3.
No. of Patients (%) | Severity | Patients with Stage 3b–5 CKD (n=421) | Patients with Stage 1–3a CKD (n=211) |
---|---|---|---|
≥1 adverse event | Any severity | 67 (15.9) | 25 (11.8) |
Mild | 45 (10.7) | 18 (8.5) | |
Moderate | 22 (5.2) | 7 (3.3) | |
Severe | 0 (0.0) | 0 (0.0) | |
Gastrointestinal disorders | Any severity | 54 (12.8) | 13 (6.2) |
Mild | 36 (8.6) | 10 (4.7) | |
Moderate | 18 (4.3) | 3 (1.4) | |
Severe | 0 (0.0) | 0 (0.0) | |
Constipation | Any severity | 30 (7.1) | 6 (2.8) |
Mild | 21 (5.0) | 6 (2.8) | |
Moderate | 9 (2.1) | 0 (0.0) | |
Severe | 0 (0.0) | 0 (0.0) | |
Diarrhea | Any severity | 12 (2.9) | 4 (1.9) |
Mild | 8 (1.9) | 4 (1.9) | |
Moderate | 4 (1.0) | 0 (0.0) | |
Severe | 0 (0.0) | 0 (0.0) | |
Metabolism and nutrition disorders | Any severity | 16 (3.8) | 7 (3.3) |
Mild | 13 (3.1) | 4 (1.9) | |
Moderate | 3 (0.7) | 3 (1.4) | |
Severe | 0 (0.0) | 0 (0.0) | |
Hypomagnesemia | Any severity | 9 (2.1) | 5 (2.4) |
Mild | 8 (1.9) | 3 (1.4) | |
Moderate | 1 (0.2) | 2 (0.9) | |
Severe | 0 (0.0) | 0 (0.0) |
This table summarizes adverse events during the first 4 weeks after the start of patiromer treatment (defined as onset on or before study day 32), regardless of the date of treatment discontinuation. Adverse event that occurred in ≥2% of patients in either subgroup.