Table 3.
Treatment-emergent AEs (reported in 5% or more in either group)
Variables | Ferric Citrate (n=117), n (%) | Placebo (n=116), n (%) |
---|---|---|
Any treatment-emergent AE | 93 (79.5) | 75 (64.7) |
Diarrhea | 24 (20.5) | 19 (16.4) |
Constipation | 22 (18.8) | 15 (12.9) |
Feces discolored | 17 (14.5) | 0 (0) |
Nausea | 13 (11.1) | 3 (2.6) |
Abdominal pain | 7 (6.0) | 2 (1.7) |
Fatigue | 0 (0) | 6 (5.2) |
Hyperkalemia | 8 (6.8) | 4 (3.4) |
Hypertension | 5 (4.3) | 6 (5.2) |
Events occurring during the randomized period (randomization to week 16).