Table 3.
Most Common (n > 1) and all Grade 3 and Above TRC105 Drug-related Adverse Events.
| Adverse Event | TRC105 | ||||||
|---|---|---|---|---|---|---|---|
| Maximum Grade | Total N = 38 | ||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | n | Percent | |
| Headache | 14 | 14 | 4 | 0 | 0 | 32 | (84.2%) |
| Epistaxis | 22 | 3 | 0 | 0 | 0 | 25 | (65.8%) |
| Telangiectasia | 17 | 2 | 0 | 0 | 0 | 19 | (50.0%) |
| Gingival bleeding | 11 | 1 | 0 | 0 | 0 | 12 | (31.6%) |
| Anemia | 0 | 3 | 8 | 0 | 0 | 11 | (28.9%) |
| Infusion reaction | 0 | 10 | 1 | 0 | 0 | 11 | (28.9%) |
| Fatigue | 1 | 7 | 2 | 0 | 0 | 10 | (26.3%) |
| Flushing | 7 | 1 | 0 | 0 | 0 | 8 | (21.1%) |
| Decreased appetite | 0 | 3 | 1 | 0 | 0 | 4 | (10.5%) |
| Facial edema | 0 | 4 | 0 | 0 | 0 | 4 | (10.5%) |
| Gingival pain | 4 | 0 | 0 | 0 | 0 | 4 | (10.5%) |
| Nasal congestion | 2 | 1 | 0 | 0 | 0 | 3 | (7.9%) |
| Nausea | 1 | 2 | 0 | 0 | 0 | 3 | (7.9%) |
| Oral pain | 3 | 0 | 0 | 0 | 0 | 3 | (7.9%) |
| Rash | 3 | 0 | 0 | 0 | 0 | 3 | (7.9%) |
| Dyspnea | 2 | 0 | 0 | 0 | 0 | 2 | (5.3%) |
| Hypothyroidism | 0 | 2 | 0 | 0 | 0 | 2 | (5.3%) |
| Periorbital edema | 1 | 1 | 0 | 0 | 0 | 2 | (5.3%) |
| Vomiting | 0 | 2 | 0 | 0 | 0 | 2 | (5.3%) |
| Brain abscess | 0 | 0 | 1 | 0 | 0 | 1 | (2.6%) |
Percents are computed by using the number of patients in the safety population as the denominator. Adverse Events are coded by using MedDRA dictionary version 14.1.
If more than 1 event is recorded for a patient, the patient is only counted once at the highest grade.