Summary of TEAEs
Event . | Cohort 1 (n = 2) . | Cohort 2 (n = 2) . | Cohort 3 (n = 2) . | Cohort 4 (n = 5) . | Total (N = 11) . | |||||
---|---|---|---|---|---|---|---|---|---|---|
Number of participants . | Number of events . | Number of participants . | Number of events . | Number of participants . | Number of events . | Number of participants . | Number of events . | Number of participants (%) . | Number of events . | |
Any AE∗ | 2 | 24 | 2 | 16 | 2 | 12 | 5 | 51 | 11 (100) | 103 |
ALT increased | 2 | 3 | 2 | 3 | 1 | 1 | 4 | 12 | 9 (82) | 19 |
AST increased | 2 | 3 | 1 | 2 | 1 | 1 | 3 | 4 | 7 (64) | 10 |
Upper respiratory tract infection | 2 | 7 | 1 | 1 | 0 | 0 | 1 | 1 | 4 (36) | 9 |
Pyrexia | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4 | 4 (36) | 4 |
Otitis media | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 2 (18) | 4 |
Headache | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 2 (18) | 4 |
Arthralgia | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 2 (18) | 2 |
Skin laceration | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 2 (18) | 2 |
Fall | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 0 | 2 (18) | 2 |
Oropharyngeal pain | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 2 (18) | 2 |
Lymphopenia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 (18) | 2 |
Tachycardia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 (18) | 2 |
Hypotension | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 2 (18) | 2 |
Any treatment-related AE† | 0 | 0 | 2 | 5 | 0 | 0 | 4 | 21 | 6 (55) | 26 |
ALT increased | 0 | 0 | 2 | 3 | 0 | 0 | 3 | 10 | 5 (46) | 13 |
AST increased | 0 | 0 | 1 | 2 | 0 | 0 | 2 | 3 | 3 (27) | 5 |
Pyrexia | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 (27) | 3 |
Tachycardia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 (18) | 2 |
Fatigue | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 (9) | 1 |
Myalgia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 (9) | 1 |
Hypotension | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 (9) | 1 |
Event . | Cohort 1 (n = 2) . | Cohort 2 (n = 2) . | Cohort 3 (n = 2) . | Cohort 4 (n = 5) . | Total (N = 11) . | |||||
---|---|---|---|---|---|---|---|---|---|---|
Number of participants . | Number of events . | Number of participants . | Number of events . | Number of participants . | Number of events . | Number of participants . | Number of events . | Number of participants (%) . | Number of events . | |
Any AE∗ | 2 | 24 | 2 | 16 | 2 | 12 | 5 | 51 | 11 (100) | 103 |
ALT increased | 2 | 3 | 2 | 3 | 1 | 1 | 4 | 12 | 9 (82) | 19 |
AST increased | 2 | 3 | 1 | 2 | 1 | 1 | 3 | 4 | 7 (64) | 10 |
Upper respiratory tract infection | 2 | 7 | 1 | 1 | 0 | 0 | 1 | 1 | 4 (36) | 9 |
Pyrexia | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4 | 4 (36) | 4 |
Otitis media | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 2 (18) | 4 |
Headache | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 2 (18) | 4 |
Arthralgia | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 2 (18) | 2 |
Skin laceration | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 2 (18) | 2 |
Fall | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 0 | 2 (18) | 2 |
Oropharyngeal pain | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 2 (18) | 2 |
Lymphopenia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 (18) | 2 |
Tachycardia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 (18) | 2 |
Hypotension | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 2 (18) | 2 |
Any treatment-related AE† | 0 | 0 | 2 | 5 | 0 | 0 | 4 | 21 | 6 (55) | 26 |
ALT increased | 0 | 0 | 2 | 3 | 0 | 0 | 3 | 10 | 5 (46) | 13 |
AST increased | 0 | 0 | 1 | 2 | 0 | 0 | 2 | 3 | 3 (27) | 5 |
Pyrexia | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 (27) | 3 |
Tachycardia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 (18) | 2 |
Fatigue | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 (9) | 1 |
Myalgia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 (9) | 1 |
Hypotension | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 (9) | 1 |
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.