Table 4.
Overall adverse event profile during treatment with molidustat or placebo/active comparator during DIALOGUEs 1, 2, and 4
| TEAEs | DIALOGUE 1 | DIALOGUE 2 | DIALOGUE 4 | |||
|---|---|---|---|---|---|---|
| Molidustata (n=101) | Placebo (n=20) | Molidustata (n=92) | Darbepoetin (n=32) | Molidustata (n=157) | Epoetin (n=42) | |
| Any TEAE | 67 (66) | 16 (80) | 64 (70) | 17 (53) | 126 (80) | 32 (76) |
| Any study drug-related TEAE | 12 (12) | 2 (10) | 8 (9) | 0 | 41 (26) | 4 (10) |
| Maximum intensity for any TEAE | ||||||
| Mild | 44 (44) | 7 (35) | 30 (33) | 7 (22) | 50 (32) | 12 (29) |
| Moderate | 18 (18) | 8 (40) | 29 (32) | 6 (19) | 43 (27) | 13 (31) |
| Severe | 5 (5) | 1 (5) | 5 (5) | 4 (13) | 33 (21) | 7 (17) |
| Any serious TEAE | 14 (14) | 5 (25) | 19 (21) | 6 (19) | 34 (22) | 7 (17) |
| Any study drug-related serious TEAE | 0 | 0 | 1 (1) | 0 | 2 (1) | 0 |
| Any TEAE resulting in death | 0 | 0 | 1 (1) | 1 (3) | 1 (1) | 0 |
| Any study drug-related TEAE resulting in death | 0 | 0 | 0 | 0 | 0 | 0 |
All data are given as n (%). All TEAEs reported were determined by the investigator. DIALOGUE, DaIly orAL treatment increasing endOGenoUs Erythropoietin; TEAE, treatment-emergent adverse event.
a
Combined-dose groups.