Table 4.
AEs of special interest.
| AEs, n (%) | Total safety population, N = 1203 |
|---|---|
| Hepatic AEsa | |
| Any AE | 222 (18) |
| Mild | 111/222 (50) |
| Moderate | 84/222 (38) |
| Severe | 27/222 (12) |
| SAEs | 16 (1) |
| AEs leading to treatment discontinuation | 12 (<1) |
| Infectionb | |
| Any AE | 751 (62) |
| Mild | 347/751 (46) |
| Moderate | 364/751 (48) |
| Severe | 39/751 (5) |
| SAEs | 62 (5) |
| AEs leading to treatment discontinuation | 15 (1) |
| Cutaneousc,d | |
| Any AE | 537 (45) |
| Mild | 273/537 (51) |
| Moderate | 241/537 (45) |
| Severe | 23/537 (4) |
| SAEs | 38 (3) |
| AEs leading to treatment discontinuation | 60 (5) |
| Lymphadenopathye | |
| Any AE | 136 (11) |
| Mild | 78/136 (57) |
| Moderate | 51/136 (38) |
| Severe | 7/136 (5) |
| SAEs | 23 (2) |
| AEs leading to treatment discontinuation | 18 (1) |
| Depression | |
| Any AE | 117 (10) |
| SAEs | 7 (<1) |
| Lymphopenia | |
| Any AE | 57 (5) |
| SAEs | 2 (<1) |
| Angioedema | |
| Any AE | 53 (4) |
| SAEs | 0 |
| Immune-mediated disorder | |
| Any AE | 30 (2) |
| SAEs | 15 (1) |
| Autoimmune encephalitis | 3 (<1) |
| Colitis | |
| Any AE | 18 (1) |
| SAEs | 5 (<1) |
| Malignancy | |
| Any AE | 16 (1) |
| Sarcoidosis | |
| Any AE | 6 (<1) |
| SAEs | 4 (<1) |
| Autoimmune hemolytic anemia | |
| Any AE | 4 (<1) |
| SAEs | 4 (<1) |
a
Defined using an SMQ for drug-related hepatic disorders, which is a sublevel of SMQ hepatic disorders and includes the preferred terms hepatobiliary disorders and investigations, among others.
b
MedDRA SOC of infections and infestations.
c
MedDRA SOC of skin and subcutaneous tissue disorders.
d
Hypersensitivity AEs were mainly cutaneous [n = 366/399 (92%)].
e
Customized MedDRA search under selected high-level terms.
AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; SMQ, standardized Medical Dictionary for Regulatory Activities query; SOC, system organ class.