Table 4.

Adverse events (all cycles)

Interim populationOverall population
n = 34N = 86
Group 1Group 2Group 1Group 2
n = 17n = 17an = 40n = 46a
n (%)n (%)n (%)n (%)
AllGrade 3–4AllGrade 3–4AllGrade 3–4AllGrade 3–4
Any17 (100)16 (94.1)16 (100)13 (81.2)40 (100)30 (75.0)45 (100)37 (82.2)
Unknown001a1a001a1a
Nonhematologic
 Diarrhea12 (70.6)4 (23.5)11 (68.7)2 (12.5)30 (75.0)7 (17.5)30 (68.2)4 (9.1)
 Nausea13 (76.5)1 (5.9)12 (75.0)2 (12.5)28 (70.0)2 (5.0)34 (77.3)3 (6.8)
 Vomiting10 (58.8)2 (11.8)10 (62.5)0 (0.0)23 (57.5)4 (10.0)27 (61.3)2 (4.5)
 Epistaxis9 (52.9)1 (5.9)7 (43.8)0 (0.0)19 (47.5)1 (2.5)19 (43.2)0 (0.0)
 Mucositis8 (47.1)0 (0.0)9 (56.3)0 (0.0)17 (42.5)2 (5.0)20 (45.4)2 (4.5)
 Hypertension4 (23.5)1 (5.9)1 (6.2)1 (6.2)8 (20.0)3 (7.5)8 (18.2)4 (9.1)
 Alopecia6 (35.3)0 (0.0)6 (37.5)2 (12.5)14 (35.0)0 (0.0)18 (40.9)6 (13.6)
 VTE7 (41.2)4 (23.6)2 (12.4)1 (6.2)8 (20.0)5 (11.5)2 (4.6)2 (4.5)
 ATE1 (5.9)1 (5.9)0 (0.0)0 (0.0)2 (5.0)2 (5.0)0 (0.0)0 (0.0)
Hematologic
 Neutropenia13 (76.5)5 (29.4)14 (87.5)6 (37.5)28 (70.0)10 (25.0)34 (75.6)14 (31.1)
 Febrile neutropenia2 (11.8)2 (11.8)2 (12.5)2 (12.5)4 (10.0)2 (5.0)5 (11.1)4 (8.9)
 Anemia16 (94.1)2 (11.8)11 (68.7)0 (0.0)33 (82.5)2 (5.0)32 (70.5)1 (2.2)
 Thrombocytemia3 (17.7)0 (0.0)5 (31.2)0 (0.0)4 (10.0)0 (0.0)13 (28.9)0 (0.0)

NOTE: Group 1: UGTA1*1/UGTA1*1; Group 2: UGT1A1*1/UGT1A1*28.

Abbreviations: VTE, venous thromboembolic event; ATE, arterial thromboembolic event.

  • a1 patient in group 2 was never treated because brain metastases were discovered after the patient's inclusion.