Table 1.
Usual Care (n = 568) | Ferric Derisomaltose (n = 569) | |||||||
---|---|---|---|---|---|---|---|---|
Deaths after randomization without preceding hospitalization | 27 Deaths | 21 Deaths |
All Hospitalizations | Main Cause |
Main or Contributory |
Main Cause |
Main or Contributory |
||||
---|---|---|---|---|---|---|---|---|
Events | Patients | Events | Patients | Events | Patients | Events | Patients | |
All causes | 1,086 | 370 (65) | a | a | 904 | 351 (62) | a | a |
CV | 589 (54) | 273 (48) | a | a | 491 (54) | 254 (45) | a | a |
Heart failure | 286 | 152 | 345 | 179 | 222 | 130 | 269 | 152 |
VT/VF | 47 | 29 | a | a | 26 | 22 | a | a |
AF/SVT | 15 | 14 | 68b | 53b | 20 | 19 | 57b | 43b |
ACS/MI | 38 | 25 | 46 | 33 | 23 | 18 | 30 | 23 |
Stroke | 10 | 10 | 12 | 12 | 24 | 21 | 29 | 24 |
AKI | 28 | 24 | 193 | 144 | 21 | 19 | 165 | 114 |
Hemorrhage | 34 | 26 | 68 | 53 | 48 | 39 | 82 | 62 |
Complications of CV therapy | 42 | 37 | 205 | 147 | 36 | 35 | 202 | 142 |
PTE | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 |
Other | 86 | 69 | a | a | 69 | 63 | a | a |
Non-CV | 497 (46) | 249 (44) | a | a | 413 (46) | 214 (38) | a | a |
Cancer | 18 | 14 | 37 | 21 | 15 | 14 | 47 | 30 |
Respiratory | 45 | 31 | 196 | 124 | 29 | 21 | 137 | 93 |
Infection | 213 | 140 | 420 | 221 | 175 | 111 | 345 | 189 |
Respiratory and infectionc | a | a | 174 | 115 | NA | NA | 130 | 88 |
Renal | 17 | 16 | 88 | 67 | 21 | 19 | 78 | 61 |
Trauma and non-CV procedures | 63 | 54 | 95 | 73 | 48 | 42 | 92 | 76 |
Other | 141 | 96 | a | a | 125 | 94 | a | a |
Values are n or n (%).
ACS = acute coronary syndrome; AF = atrial fibrillation; AKI = acute kidney injury (see text for explanation of cardiorenal); CV = cardiovascular; MI = myocardial infarction; PTE = pulmonary thromboembolism; SVT = supraventricular tachycardia; VF = ventricular fibrillation; VT = ventricular tachycardia.
Not appropriate or not calculated.
Arrhythmias complicating other hospitalizations were not further adjudicated as SVT or VT but were considered to be predominantly SVT.
Respiratory and infection includes patients with a respiratory admission with infection as contributory or admission for infection with respiratory disease as contributory. This includes patients in the 2 previous rows who had both as either main or contributory causes.