Table 3.

Characteristics of FDA-adjudicated DS cases.

IvosidenibEnasidenib
(n = 34)(n = 41)
Severity, n (%)
 Moderate24 (71)33 (80)a
 Severe8 (24)5 (12)a
 Indeterminate2 (6)4 (10)
Grade ≥ 3 ARs, n (%)
 Yes23 (68)27 (66)
 Fatal2 (6)2 (5)
Clinical criteria, n (%)
 Dyspnea26 (76)28 (68)
 Pulmonary infiltrates, pleuropericardial effusion26 (76)25 (61)
 Weight gain18 (53)17 (41)
 Fever15 (44)21 (51)
 Acute renal failure8 (24)7 (17)
 Hypotension6 (18)3 (7)
Leukocytosis
 Yes27 (79)25 (61)
Time to onset
 Median (range), d20 (1–78)19 (1–86)
 ≤7 days, n (%)4 (12)6 (15)
 >7 days, n (%)30 (88)35 (85)
Multiple episodes
 Yes4 (12)6 (15)
  • Abbreviation: d, days.

  • aOne patient with multiple episodes of DS had both severe and moderate episodes.