Table 2.

Number of patients with AEs by maximal severity and MedDRA preferred term (frequency of AEs ≥10.0% of the total patients by preferred term)

Number of patients withAPG101 +aaTotal
AE by MedDRA(n = 58)(n = 26)(n = 84)
preferred termn (%)n (%)n (%)
MildMod.SevereMildMod.SevereMildMod.Severe
Any AE9 (15.5)27 (46.6)22 (37.9)3 (11.5)9 (34.6)13 (50.0)12 (14.3)36 (42.9)35 (41.7)
Nervous system disorders12 (20.7)31 (53.4)11 (19.0)4 (15.4)8 (30.8)10 (38.5)16 (19.0)39 (46.4)21 (25.0)
 Aphasia2 (3.4)2 (3.4)3 (5.2)0 (0.0)4 (15.4)1 (3.8)2 (2.4)6 (7.1)4 (4.8)
 Brain edema2 (3.4)7 (12.1)0 (0.0)2 (7.7)4 (15.4)1 (3.8)4 (4.8)11 (13.1)1 (1.2)
 Cognitive disorder2 (3.4)5 (8.6)2 (3.4)2 (7.7)1 (3.8)0 (0.0)4 (4.8)6 (7.1)2 (2.4)
 Convulsion2 (3.4)5 (8.6)3 (5.2)2 (7.7)1 (3.8)2 (7.7)4 (4.8)6 (7.1)5 (6.0)
 Coordination abnormal3 (5.2)6 (10.3)2 (3.4)2 (7.7)1 (3.8)0 (0.0)5 (6.0)7 (8.3)2 (2.4)
 Headache13 (22.4)13 (22.4)1 (1.7)4 (15.4)2 (7.7)1 (3.8)17 (20.1)15 (17.9)2 (2.4)
 Hemiparesis3 (5.2)4 (6.9)3 (5.2)0 (0.0)3 (11.5)3 (11.5)3 (3.6)7 (8.3)6 (7.1)
 Hypoaestesia8 (13.8)0 (0.0)0 (0.0)2 (7.7)2 (7.7)0 (0.0)10 (11.9)2 (2.4)2 (2.4)
 Motor dysfunction2 (3.4)5 (8.6)0 (0.0)2 (7.7)0 (0.0)0 (0.0)4 (4.8)5 (6.0)0 (0.0)
 Neurologic decompensation0 (0.0)4 (6.9)2 (3.4)1 (3.8)1 (3.8)5 (19.2)1 (1.2)5 (6.0)7 (8.3)
 Partial seizures5 (8.6)6 (10.3)0 (0.0)0 (0.0)1 (3.8)1 (3.8)5 (6.0)7 (8.3)1 (1.2)
General disorders and administration site conditions12 (20.7)14 (24.1)7 (12.1)0 (0.0)6 (23.1)7 (26.9)12 (14.3)20 (23.8)14 (16.7)
 Disease progression1 (1.7)1 (1.7)4 (6.9)0 (0.0)1 (3.8)4 (15.4)1 (1.2)2 (2.4)8 (9.5)
 Fatigue4 (6.9)11 (19.0)0 (0.0)3 (11.5)3 (11.5)0 (0.0)7 (8.3)14 (16.7)0 (0.0)
 General physical health deterioration0 (0.0)4 (6.9)2 (3.4)0 (0.0)3 (11.5)1 (3.8)0 (0.0)7 (8.3)3 (3.6)
Gastrointestinal disorders20 (34.5)7 (12.1)1 (1.7)6 (23.1)3 (11.5)1 (3.8)26 (31.0)10 (11.9)2 (2.4)
 Nausea7 (12.1)4 (6.9)0 (0.0)3 (11.5)0 (0.0)0 (0.0)10 (11.9)4 (4.8)0 (0.0)
 Vomiting7 (12.1)2 (3.4)0 (0.0)1 (3.8)0 (0.0)0 (0.0)8 (9.5)2 (2.4)0 (0.0)
Musculoskeletal and connective tissue disorders11 (19.0)9 (15.5)1 (1.7)0 (0.0)2 (7.7)1 (3.8)11 (13.1)11 (13.1)2 (2.4)
Pain in extremity4 (6.9)3 (5.2)1 (1.7)0 (0.0)1 (3.8)0 (0.0)4 (4.8)4 (4.8)1 (1.2)
Investigations10 (17.2)6 (10.3)2 (3.4)3 (11.5)2 (7.7)1 (3.8)13 (15.5)8 (9.5)3 (3.6)
 Karnofsky scale worsened5 (8.6)2 (3.4)0 (0.0)1 (3.8)2 (7.7)0 (0.0)6 (7.1)4 (4.8)0 (0.0)
Psychiatric disorders9 (15.5)6 (10.3)2 (3.4)4 (15.4)4 (15.4)0 (0.0)13 (15.5)10 (11.9)2 (2.4)
 Depression3 (5.2)2 (3.4)1 (1.7)1 (3.8)2 (7.7)0 (0.0)4 (4.8)4 (4.8)1 (1.2)

Abbreviations: N, number of patients; Mod, moderate.

  • aPatients in the rRT+APG101 arm have been seen weekly during the post-rRT phase until progression, whereas patients in the rRT arm were seen 6-weekly.