Event | Number of events | Number (%) of patients |
---|---|---|
Any adverse eventa | 120 | 21 (91) |
Any TEAE | 93 | 20 (87) |
Any serious TEAE | 12 | 10 (43) |
Any treatment-related TEAE | 0 | 0 (0) |
Frequent TEAEs by MedDRA system organ classb | ||
General disorders and administration site conditions | 3 (13) | |
Edema peripheral | 2 (9) | |
Infections and infestations | 15 (65) | |
Infected skin ulcer | 6 (26) | |
Localized infection | 4 (17) | |
Nasopharyngitis | 4 (17) | |
Wound infection | 2 (9) | |
Injury, poisoning and procedural complications | 5 (22) | |
Ligament sprain | 2 (9) | |
Metabolism and nutrition disorders | 4 (17) | |
Hyperglycemia | 2 (9) | |
Musculoskeletal and connective tissue disorders | 4 (17) | |
Arthralgia | 2 (9) | |
Back pain | 2 (9) | |
Pain in extremity | 3 (13) | |
Skin and subcutaneous tissue disorders | 11 (48) | |
Blisters | 6 (26) | |
Skin ulcer | 4 (17) |