Table 2.

Summary of safety and incidence of all-grade and grade 3 or 4 TEAEs occurring in ≥20% of patients overall.

CopanlisibCopanlisibCopanlisibCopanlisib
0.4 mg/kg0.8 mg/kg45 mg60 mgTotal
n (%)a(n = 34)(n = 27)(n = 1)b(n = 1)b(N = 63)
Any TEAE31 (91.2)26 (96.3)1 (100)1 (100)59 (93.7)
Worst CTCAE grade
 100000
 27 (20.6)2 (7.4)009 (14.3)
 315 (44.1)17 (63.0)1 (100)033 (52.4)
 43 (8.8)4 (14.8)01 (100)8 (12.7)
 56 (17.6)3 (11.1)009 (14.3)c
TEAEs occurring in ≥15% of patientsAll gradeGrade 3 or 4All gradeGrade 3 or 4All gradeGrade 3 or 4All gradeGrade 3 or 4All gradeGrade 3 or 4
 Hyperglycemia14 (41.2)2 (5.9)17 (63.0)11 (40.7)1 (100)1 (100)1 (100)1 (100)33 (52.4)15 (23.8)
 Fatigue13 (38.2)1 (2.9)14 (51.9)1 (3.7)1 (100)01 (100)029 (46.0)2 (3.2)
 Hypertension11 (32.4)7 (20.6)13 (48.1)10 (37.0)1 (100)1 (100)1 (100)1 (100)26 (41.3)19 (30.2)
 Nausea11 (32.4)1 (2.9)12 (44.4)01 (100)00024 (38.1)1 (1.6)
 Diarrhea5 (14.7)016 (59.3)1 (3.7)000021 (33.3)1 (1.6)
 Anemia8 (23.5)1 (2.9)10 (37.0)5 (18.5)000018 (28.6)6 (9.5)
 Dyspnea8 (23.5)1 (2.9)7 (25.9)01 (100)00016 (25.4)1 (1.6)
 Pain8 (23.5)07 (25.9)01 (100)00016 (25.4)0
 Constipation8 (23.5)06 (22.2)01 (100)00015 (23.8)0
 Vomiting6 (17.6)2 (5.9)8 (29.6)01 (100)00015 (23.8)2 (3.2)
 Anorexia7 (20.6)06 (22.2)01 (100)00014 (22.2)0
 Decreased appetite7 (20.6)06 (22.2)01 (100)00014 (22.2)0
 Oral mucositis3 (8.8)011 (40.7)0000014 (22.2)0
 Abdominal pain4 (11.8)07 (25.9)1 (3.7)1 (100)00012 (19.0)1 (1.6)
 Cough6 (17.6)06 (22.2)1 (3.7)000012 (19.0)1 (1.6)
 Metabolism and nutrition disorders—other, specify4 (11.8)1 (2.9)7 (25.9)0000011 (17.5)1 (1.6)
 Fever4 (11.8)06 (22.2)1 (3.7)000010 (15.9)1 (1.6)
 Headache2 (5.9)08 (29.6)0000010 (15.9)0
 Hypophosphatemia2 (5.9)07 (25.9)6 (22.2)001 (100)1 (100)10 (15.9)7 (11.1)
  • aNumber (%) of patients with the specified event starting or worsening between start of treatment and 48 days after end of treatment.

  • bPatient with diabetes.

  • cAn additional 6 deaths were recorded after the 48-day safety follow-up window after permanent treatment discontinuation.