Analysis of Treatment Emergent Adverse Events in Module 1 (Monotherapy) Part A (Dose Escalation)
nausea, fatigue, toxicity, vomiting, PD, headache, Nausea
DISEASE
In 23 out of 24 patients in Module 1 Part A (monotherapy, dose-escalation), 129 drug-related TEAE were recorded. The most common drug-related TEAE (≥ 20%) were nausea (11 patients, 46%), fatigue (10 patients, 42%), vomiting (9 patients, 38%), increased blood creatinine (9 patients, 38%), and headache (5 patients, 21%) (Most common drug-related AEs in order of frequency in Module 1 Part A.In total, 11 drug-related SAEs were reported in 7 patients. Nausea and vomiting were reported as drug-related SAEs in more than 1 patient (in 3 and 2 patients respectively).No grade 5 (fatal) TEAEs were recorded.Six patients were on treatment with OMO-1 for more than 100 days of which 2 patients exceeded 200 days (Time on treatment of patients in Module 1, Part A (dose-escalation) in days and reasons for discontinuation. PD, progressive disease, including RECIST v.1.1. confirmed progressive disease and clinical evidence of progressive disease, tox, drug-related toxicity leading to discontinuation, oth, other reason for discontinuation of treatment.