Table 3.

Summary of TEAEs

EventCohort 1 (n = 2)Cohort 2 (n = 2)Cohort 3 (n = 2)Cohort 4 (n = 5)Total (N = 11)
Number of participantsNumber of eventsNumber of participantsNumber of eventsNumber of participantsNumber of eventsNumber of participantsNumber of eventsNumber of participants (%)Number of events
Any AE  24 16 12 51 11 (100) 103 
ALT increased 12 9 (82) 19 
AST increased 7 (64) 10 
Upper respiratory tract infection 4 (36) 
Pyrexia 4 (36) 
Otitis media 2 (18) 
Headache 2 (18) 
Arthralgia 2 (18) 
Skin laceration 2 (18) 
Fall 2 (18) 
Oropharyngeal pain 2 (18) 
Lymphopenia 2 (18) 
Tachycardia 2 (18) 
Hypotension 2 (18) 
Any treatment-related AE  21 6 (55) 26 
ALT increased 10 5 (46) 13 
AST increased 3 (27) 
Pyrexia 3 (27) 
Tachycardia 2 (18) 
Fatigue 1 (9) 
Myalgia 1 (9) 
Hypotension 1 (9) 
EventCohort 1 (n = 2)Cohort 2 (n = 2)Cohort 3 (n = 2)Cohort 4 (n = 5)Total (N = 11)
Number of participantsNumber of eventsNumber of participantsNumber of eventsNumber of participantsNumber of eventsNumber of participantsNumber of eventsNumber of participants (%)Number of events
Any AE  24 16 12 51 11 (100) 103 
ALT increased 12 9 (82) 19 
AST increased 7 (64) 10 
Upper respiratory tract infection 4 (36) 
Pyrexia 4 (36) 
Otitis media 2 (18) 
Headache 2 (18) 
Arthralgia 2 (18) 
Skin laceration 2 (18) 
Fall 2 (18) 
Oropharyngeal pain 2 (18) 
Lymphopenia 2 (18) 
Tachycardia 2 (18) 
Hypotension 2 (18) 
Any treatment-related AE  21 6 (55) 26 
ALT increased 10 5 (46) 13 
AST increased 3 (27) 
Pyrexia 3 (27) 
Tachycardia 2 (18) 
Fatigue 1 (9) 
Myalgia 1 (9) 
Hypotension 1 (9) 

AST, aspartate aminotransferase.

Number of participants with at least 1 TEAE reported in the study population.

For any AE, only the TEAEs reported by at least 2 participants are included in this table. Similarly for any treatment-related AE, only the treatment-related TEAEs reported by at least 1 participant are included.