Table 2.

Summary of AEs while on venetoclax or up to 30 days posttreatment

Subgroups of interest
All patientsdel(17p) CLLPrior BCRi
Event, n (%)N = 350n = 211an = 148a
Any grade AE343 (98)207 (98)144 (97)
Common any grade AEs (≥10% of all patients)
 Diarrhea145 (41)85 (40)57 (39)
 Neutropenia141 (40)83 (39)54 (37)
 Nausea137 (39)71 (34)57 (39)
 Anemiab109 (31)62 (29)57 (39)
 Fatigue99 (28)52 (25)41 (32)
 Upper respiratory tract infection86 (25)44 (21)26 (18)
 Thrombocytopenia74 (21)46 (22)34 (23)
 Cough63 (18)32 (15)29 (20)
 Headache62 (18)37 (18)23 (16)
 Pyrexia60 (17)35 (17)20 (14)
 Constipation56 (16)26 (12)22 (15)
 Vomiting55 (16)31 (15)23 (16)
 Hyperkalemiac52 (15)34 (16)27 (18)
 Hyperphosphatemiac48 (14)25 (12)21 (14)
 Peripheral edema47 (13)25 (12)24 (16)
 Hypocalcemiac41 (12)19 (9)26 (18)
 Pneumonia40 (11)25 (12)14 (10)
 Back pain39 (11)23 (11)15 (10)
 Abdominal pain37 (11)17 (8)12 (8)
 Dizziness37 (11)18 (9)13 (9)
 Dyspnea37 (11)24 (11)21 (14)
Grade 3/4 AEs274 (78)164 (78)108 (73)
Common grade 3/4 AEs (≥10% of all patients)
 Neutropenia128 (37)76 (36)47 (32)
 Anemia60 (17)33 (16)33 (22)
 Thrombocytopenia49 (14)30 (14)23 (16)
SAEs181 (52)114 (54)64 (43)
Common SAEs (≥2% of all patients)
 Pneumonia24 (7)17 (8)9 (6)
 Febrile neutropenia17 (5)9 (4)10 (7)
 Pyrexia12 (3)9 (4)2 (2)
 Autoimmune hemolytic anemia10 (3)8 (4)2 (2)
AEs leading tod
 Dose reduction45 (13)26 (12)16 (11)
 Dose interruption120 (34)67 (32)45 (30)
 Discontinuation35 (10)23 (11)14 (10)
 Death15 (3)10 (5)9 (6)
  • Abbreviation: BCRi, B-cell receptor pathway inhibitors (ibrutinib, idelalisib, or investigational compounds).

  • aSubgroups include patients across all three clinical studies. The 211 patients with del(17p) CLL and 148 patients who received prior BCRi are not mutually exclusive and do not add up to the 350 patients included in the overall integrated dataset.

  • bIncludes the Medical Dictionary for Regulatory Activities (MedDRA) preferred term “anemia” and does not include events of autoimmune hemolytic anemia.

  • cThe majority of laboratory changes reported as AEs occurred during the dose ramp-up period: 26/52 events of hypokalemia, 46 of 48 events of hyperphosphatemia, and 39 of 41 events of hypocalcemia.

  • dExcludes those due to disease progression.