AEs
| Original dose regimen . | Overall (N = 34) . |
|---|---|
| TEAE, n (%) | |
| At least 1 TEAE | 33 (97.1) |
| Leading to study discontinuation∗ | 5 (14.7) |
| Leading to study withdrawal† | 3 (8.8) |
| Most common TEAEs, n (%) | |
| ALT increased | 10 (29.4) |
| Headache | 9 (26.5) |
| Arthralgia | 8 (23.5) |
| Injection site erythema | 7 (20.6) |
| Nasopharyngitis | 7 (20.6) |
| Back pain | 6 (17.6) |
| Diarrhea | 6 (17.6) |
| Upper respiratory tract infection | 6 (17.6) |
| Transaminase increased | 6 (17.6) |
| Abdominal pain | 4 (11.8) |
| Cough | 4 (11.8) |
| Gastrointestinal reflux disease | 4 (11.8) |
| Vomiting | 4 (11.8) |
| Influenza-like illness | 4 (11.8) |
| Pain in extremity | 4 (11.8) |
| TESAE, n (%) | |
| At least 1 TESAE | 13 (38.2) |
| Leading to study withdrawal‡ | 1 (2.9) |
| Most common TESAE, cholecystitis, n (%) | 2 (5.9) |
| AT-based dose regimen | Overall (N = 18) |
| TEAE, n (%) | |
| At least 1 TEAE | 14 (77.8) |
| Leading to study discontinuation§ | 1 (5.6) |
| Leading to study withdrawal|| | 1 (5.6) |
| Most common TEAEs, n (%) | |
| COVID-19 | 2 (11.1) |
| Viral upper respiratory tract infection | 2 (11.1) |
| TESAE, n (%) | |
| At least 1 TESAE | 1 (5.6) |
| Leading to study withdrawal¶ | 1 (5.6) |
| Most common TESAE, hepatocellular carcinoma, n (%) | 1 (5.6) |
| Original dose regimen . | Overall (N = 34) . |
|---|---|
| TEAE, n (%) | |
| At least 1 TEAE | 33 (97.1) |
| Leading to study discontinuation∗ | 5 (14.7) |
| Leading to study withdrawal† | 3 (8.8) |
| Most common TEAEs, n (%) | |
| ALT increased | 10 (29.4) |
| Headache | 9 (26.5) |
| Arthralgia | 8 (23.5) |
| Injection site erythema | 7 (20.6) |
| Nasopharyngitis | 7 (20.6) |
| Back pain | 6 (17.6) |
| Diarrhea | 6 (17.6) |
| Upper respiratory tract infection | 6 (17.6) |
| Transaminase increased | 6 (17.6) |
| Abdominal pain | 4 (11.8) |
| Cough | 4 (11.8) |
| Gastrointestinal reflux disease | 4 (11.8) |
| Vomiting | 4 (11.8) |
| Influenza-like illness | 4 (11.8) |
| Pain in extremity | 4 (11.8) |
| TESAE, n (%) | |
| At least 1 TESAE | 13 (38.2) |
| Leading to study withdrawal‡ | 1 (2.9) |
| Most common TESAE, cholecystitis, n (%) | 2 (5.9) |
| AT-based dose regimen | Overall (N = 18) |
| TEAE, n (%) | |
| At least 1 TEAE | 14 (77.8) |
| Leading to study discontinuation§ | 1 (5.6) |
| Leading to study withdrawal|| | 1 (5.6) |
| Most common TEAEs, n (%) | |
| COVID-19 | 2 (11.1) |
| Viral upper respiratory tract infection | 2 (11.1) |
| TESAE, n (%) | |
| At least 1 TESAE | 1 (5.6) |
| Leading to study withdrawal¶ | 1 (5.6) |
| Most common TESAE, hepatocellular carcinoma, n (%) | 1 (5.6) |
AEs leading to study drug discontinuation included dyspnea (n = 1), transaminases increased (n = 2), atrial thrombosis (n = 1), and CVST (initially misdiagnosed as subarachnoid hemorrhage, [n = 1]).
AEs leading to study withdrawal included CVST (initially misdiagnosed as subarachnoid hemorrhage, [n = 1]), dyspnea (n = 1), and transaminase increased (n = 1).
Serious AE leading to study withdrawal was CVST (initially misdiagnosed as subarachnoid hemorrhage).
AE leading to study drug discontinuation was hepatocellular carcinoma (n = 1).
AE leading to study withdrawal was hepatocellular carcinoma (n = 1).
Serious AE leading to study withdrawal was hepatocellular carcinoma (n = 1).