TABLE 3.
Serious AEs
| Patient | AE (MedDRA preferred term) |
Vemurafenib dose, mg BID | Onset, study day | Duration, days | Gradea | Vemurafenib treatment-relatedb |
|---|---|---|---|---|---|---|
| 1 | Spinal pain | 720 | 160 | 19 | 3 | No |
|
| ||||||
| Nephrolithiasis | 960 | 32 | 5 | 2 | No | |
| 4 | Adrenal insufficiency | 171 | 7 | 2 | No | |
| Intracranial tumor hemorrhagec | 304 | 5 | 5 | No | ||
|
| ||||||
| Maculopapular rash | 960 | 9 | 105 | 3 | No | |
| 6 | BCC | 85 | 12 | 3 | Yes | |
| SCC | 85 | 12 | 3 | Yes | ||
AE, adverse event; BCC, basal cell carcinoma; BID, twice daily; MedDRA, Medical Dictionary for Regulatory Activities; SCC, squamous cell carcinoma.
a
Maximum observed CTCAE grade.
b
As determined by the investigator.
c
Occurred 10 days after the patient had discontinued study drug due to PD (confirmed by brain CT).