Table 3.

Adverse Events

Event category	All	Late arm	Early arm
Eye disorders	7	1	6
Gastrointestinal disorders	31	18	13
General/Constitutional	31 (3)	12 (1)	20 (2)
Infectious	7 (2)	4 (1)	3 (1)
Injury/Falls	9	7	2
Hematologic	23 (11)	13 (5)	10 (6)a
Immune system	1	0	1
Nutrition/Metabolism	7 (2)	4 (1)	3 (1)
Musculoskeletal and connective tissue	5 (2)	3 (1)	2 (1)
Nervous system	37 (6)	11 (4)	26 (2)b
Psychiatric	15	7	8
Renal	2	0	2
Respiratory	5	2	3
Skin/Cutaneous	9	7	2
Vascular disorder	2 (1)	0	2 (1)c

Summary of adverse events by category, grouped by study arm. Number of grade 3 or higher events are included in paracenteses. There were no grade 5 events. A given participant may have multiple events (e.g. neutropenia and leukopenia). Two grade 4 events observed in the Early Arm were determined related to the study^a and two unrelated to the study^b,c

^aTwo participants developed grade 4 neutropenia, one of whom requiring dose delay

^bTwo weeks post-LITT, a patient presented to the emergency department with acute altered mental status, nausea, and somnolence. Acute interval ventriculomegaly was discovered on imaging prompting the placement of a left-sided external ventriculostomy drain. Subsequent CSF evaluation identified an incidental acute bacterial meningitis which was ultimately managed with antibiotics. As the patient had not received the chemotherapy for the study, it was determined unrelated to the study

^c Two weeks post-LITT, a patient presented to the emergency department with acute altered mental status, nausea, and somnolence. Acute interval ventriculomegaly was discovered on imaging prompting the placement of a left-sided external ventriculostomy drain. Subsequent CSF evaluation identified an incidental acute bacterial meningitis which was ultimately managed with antibiotics. As the patient had not received the chemotherapy for the study, it was determined unrelated to the study.