Table 2.
MEL 55 maximum grade treatment-related adverse events
Adverse event category | Adverse event description | Study groups | Total study | |
---|---|---|---|---|
Arm A IM N = 13 |
Arm B ID/SC N = 12 |
Both arms N = 25 |
||
Gr 2 | Gr 2 | Gr 2 | ||
General disorders and administration site conditions | Chills | 1 | 1 | |
Fatigue | 4 | 2 | 6 | |
Fever | 1 | 1 | ||
Flu-like symptoms | 1 | 2 | 3 | |
Injection site reaction | 10 | 7 | 17 | |
Injury, poisoning and procedural complications | Wound complication | 1 | 1 | |
Investigations | Lymphocyte count DECR | 1 | 1 | |
Total | 18 | 12 | 30 |