Table 2:
Select adverse events possibly, probably or definitely related to Pembrolizumab and/or HDI (N=30)*
| Type | Any Grade | Grade 3 | Grade 4 | |||
|---|---|---|---|---|---|---|
| No. Patients | % | No. Pts. | % | No. Pts. | % | |
| Rash maculopapular | 11 | 37 | - | - | - | - |
| Diarrhea/Colitis | 16 | 53 | 1 | 3 | - | - |
| AST elevation | 24 | 80 | - | - | - | - |
| ALT elevation | 17 | 57 | 2 | 7 | ||
| Adrenal insufficiency | 3 | 10 | - | - | - | - |
| Hypothyroidism | 9 | 30 | - | - | - | - |
| Lipase increased | 10 | 33 | 4 | 13 | - | - |
| Hyponatremia | 19 | 63 | 1 | 3 | - | - |
| Hypophosphatemia | 23 | 77 | 13 | 43 | - | - |
| Depression | 6 | 20 | - | - | - | - |
| Arthralgia | 5 | 17 | 1 | 3 | - | - |
| CPK elevation | 17 | 57 | 6 | 20 | 1 | 3 |
| Fatigue | 30 | 100 | 11 | 37 | - | - |
| Fever | 19 | 63 | 1 | 3 | - | - |
| Lymphopenia | 15 | 50 | 4 | 13 | 1 | 3 |
| Myalgia | 16 | 53 | - | - | - | - |
*
One grade 5 event occurred 6 months after completion of therapy with autopsy evidence of pneumonia and myocarditis.