Table 3.
Clinical adverse events and laboratory abnormalities through Week 48
| N = 79 | ||
|---|---|---|
| Frequency | Percent | |
| Clinical adverse events | ||
| Rash (any grade)a | 5 | 6.3 |
| Any Grade 2 or higher sign/symptom | 18 | 22.8 |
| Individual Grade 2 or higher signs/symptoms | ||
| Psychiatric symptoms | 2 | 2.5 |
| Headache | 2 | 2.5 |
| Nausea/vomiting | 1 | 1.3 |
| Diarrhea | 1 | 1.3 |
| New/worsened Grade 3 or 4 sign/symptom | 10 | 12.7 |
| Grade 3 or 4 sign/symptom at least possibly related to ETRb | 3 | 3.8 |
| Laboratory abnormalities | ||
| Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation (Grade 2 or higher)c | 5 | 6.3 |
| Grade 2 creatinine elevation | 2 | 2.5 |
| New/worsened grade 3 or 4 laboratory abnormalities | 6 | 7.6 |
| Grade 3 or 4 lab abnormalities at least possibly related to ETRb | 3 | 3.8 |
| ETR discontinued due to toxicity | 3 | 3.8 |
| Grade 2 rash | 1 | 1.3 |
| Grade 2 rash concurrent with Grade 1 AST elevation | 1 | 1.3 |
| Grade 2 elevations in AST, ALT, and total bilirubin | 1 | 1.3 |
Number of participants in each event category (and percent among n=79) is displayed; the 1 participant who never started treatment was excluded.
a
All rashes were Grade 2
b
Judged by investigator to be possibly, probably, or definitely related to ETR
c
Four participants had Grade 2 AST/ALT elevations, and 1 had Grade 2 and Grade 3 elevations.