Table 3 Adverse events
From: Intraoperative nerve-specific fluorescence visualization in head and neck surgery: a Phase 1 trial
Cohort | Dose | Age, Sex | Adverse Event | Serious | Relationship to bevonescein | Severity (Grade) | Outcome (as of study completion) |
|---|---|---|---|---|---|---|---|
Dose-Defining | 100 mg | 40 F | Nausea | No | Unlikely related | 1 | Resolved |
Body aches | No | Unlikely related | 1 | Resolved | |||
100 mg | 56 F | Chills | No | Unlikely related | 1 | Resolved | |
Non-cardiac chest pain | No | Unrelated | 1 | Resolved | |||
Nerve damage (foot) | No | Unrelated | 1 | Not resolved | |||
Urinary tract infection | No | Unrelated | 1 | Not resolved | |||
200 mg | 54 F | Dysphonia | No | Unrelated | 1 | Resolving | |
400 mg | 53 M | Left face paresis | No | Unrelated | 1 | Resolved | |
Leg soreness (bilateral) | No | Unrelated | 1 | Resolved | |||
Left antecubital skin bruising | No | Unrelated | 1 | Resolved | |||
Seroma, surgical site | No | Unrelated | 1 | Resolved | |||
600 mg | 59 M | Neck Infection, sialoadenitis | Yes | Unrelated | 3 | Resolved | |
COVID-19 infection | No | Unrelated | 1 | Resolved | |||
Salivary gland fistula | No | Unrelated | 1 | Not resolved | |||
600 mg | 54 F | Dry skin (face) | No | Unrelated | 1 | Resolved | |
Dose-Timing 1–3 h | 500 mg | 68 F | Marginal nerve weakness (right) | No | Unrelated | 1 | Not resolved |
Neck abscess | No | Unrelated | 2 | Not resolved | |||
53 F | Facial asymmetry | No | Unrelated | 1 | Not resolved | ||
Lower lip weakness (right) | No | Unrelated | 1 | Not resolved | |||
Sialocele (parotid) | No | Unrelated | 2 | Resolved | |||
21 F | Skin tenderness (incision site) | No | Unrelated | 1 | Not resolved | ||
Urinary tract infection | No | Unrelated | 1 | Resolved | |||
Numbness (ear lobe, right) | No | Unrelated | 1 | Not resolved | |||
Weakness (brow, right) | No | Unrelated | 1 | Not resolved | |||
Dose-Timing 3–5 h | 500 mg | 67 F | Preauricular edema | No | Unrelated | 1 | Resolved |
Dizziness | No | Unrelated | 1 | Resolved | |||
Shortness of breath | No | Unrelated | 2 | Resolved | |||
66 M | Shoulder pain (bilateral) | No | Unrelated | 1 | Resolved | ||
Neck stiffness | No | Unrelated | 1 | Resolved | |||
Dental infection (first episode) | Yes | Unrelated | 3 | Resolved with sequelae | |||
Dental infection (second episode) | No | Unrelated | 2 | Resolved | |||
48 M | Dry heaves | No | Possibly related | 1 | Resolved |
