Table 7.
Most common TAAEs* (experienced by >5% of subjects), ITT population.
| Total number TAAEs | By patient (n = 49) | By infusion (n = 667) | ||
|---|---|---|---|---|
| 241 | 241 | |||
| n | % | n | % | |
| Number of subjects/infusions with TAAEs | 42 | 85.7 | 149 | 22.3 |
| Headache | 24 | 49.0 | 68 | 10.2 |
| Nausea | 12 | 24.5 | 20 | 3.0 |
| Fatigue | 9 | 18.4 | 29 | 4.3 |
| Nasal congestion | 5 | 10.2 | 5 | 0.7 |
| Cough | 4 | 8.2 | 5 | 0.7 |
| Diarrhea | 4 | 8.2 | 4 | 0.6 |
| Arthralgia | 3 | 6.1 | 4 | 0.6 |
| Pyrexia | 3 | 6.1 | 4 | 0.6 |
| Sinus congestion | 3 | 6.1 | 4 | 0.6 |
| Abdominal pain upper | 3 | 6.1 | 3 | 0.4 |
| Infusion site extravasation | 3 | 6.1 | 3 | 0.4 |
| Pain | 3 | 6.1 | 3 | 0.4 |
| Oropharyngeal pain | 3 | 6.1 | 3 | 0.4 |
| Urticaria | 3 | 6.1 | 3 | 0.4 |
*TAAE, Temporally associated adverse event occurring during or within 72 hours following infusion of GC5107, whether or not it was thought to be caused by GC5107, by MedDRA preferred term.