Table 2 Summary of adverse events by baseline diabetes status (SAS)
Adverse events | Diabetes (N = 476) | No diabetes (N = 634) | ||||||
|---|---|---|---|---|---|---|---|---|
FCM (n = 232) | Placebo (n = 244) | FCM (n = 327) | Placebo (n = 307) | |||||
Subjects, n (%) | Events, n | Subjects, n (%) | Events, n | Subjects, n (%) | Events, n | Subjects, n (%) | Events, n | |
All adverse events | 167 (72.0) | 619 | 186 (76.2) | 719 | 207 (63.3) | 680 | 188 (61.2) | 652 |
All TEAEs | 163 (70.3) | 601 | 181 (74.2) | 693 | 194 (59.3) | 645 | 179 (58.3) | 621 |
  Related to study drug | 9 (3.9) | 12 | 0 | 0 | 3 (0.9) | 3 | 2 (0.7) | 2 |
  Leading to treatment discontinuation | 35 (15.1) | 39 | 46 (18.9) | 52 | 26 (8.0) | 32 | 33 (10.7) | 36 |
  Leading to hospitalization | 106 (45.7) | 237 | 132 (54.1) | 312 | 120 (36.7) | 246 | 125 (40.7) | 249 |
  Leading to study discontinuation | 52 (22.4) | 61 | 47 (19.3) | 59 | 46 (14.1) | 56 | 49 (16.0) | 64 |
Serious TEAEs | 120 (51.7) | 272 | 146 (59.8) | 348 | 130 (39.8) | 275 | 136 (44.3) | 284 |
  Related to study drug | 1 (0.4) | 3 | 0 | 0 | 0 | 0 | 2 (0.7) | 2 |
Fatal TEAEs | 52 (22.4) | 61 | 48 (19.7) | 60 | 47 (14.4) | 57 | 48 (15.6) | 63 |
  Related to study drug | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |