Table 1.
Adverse Events Considered Possibly, Probably, or Definitely Related to the Study Regimen (CTCAE version 3)
| Type | All Grades |
Grade 3 |
Grade 4 |
|||
|---|---|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | No. of Patients | % | |
| Immune mediated | ||||||
| Diarrhea/colitis | 21 | 57.0 | 3 | 8.0 | 1 | 2.7 |
| Hyper/pothyroidism | 2 | 5.4 | 0 | 0 | 0 | 0 |
| Hypogonadism | 1 | 2.7 | 0 | 0 | 0 | 0 |
| Hepatitis-increased AST/ALT/AP/GGT | 8 | 21.6 | 3 | 8.0 | 1* | 2.7 |
| Skin rash | 23 | 62.0 | 4 | 11.0 | 0 | 0 |
| Constitutional | ||||||
| Fatigue | 37 | 100 | 15 | 40.5 | 0 | 0 |
| Gastrointestinal | ||||||
| Nausea | 27 | 73.0 | 1 | 2.7 | 0 | 0 |
| Vomiting | 17 | 46.0 | 1 | 2.7 | 0 | 0 |
| Hematologic | ||||||
| Neutropenia | 19 | 51.4 | 5 | 13.5 | 1 | 2.7 |
| Neuropsychiatric | ||||||
| Depression/anxiety | 9 | 24.3 | 4 | 11.0 | 0 | 0 |
| Renal | ||||||
| Increased Cr/dehydration | 2 | 5.4 | 1 | 2.7 | 0 | 0 |
| Respiratory | ||||||
| Bronchospasm | 1 | 2.7 | 1 | 2.7 | 0 | 0 |
| Other | ||||||
| Cardiac arrhythmia (atrial fibrillation) | 1 | 2.7 | 1 | 2.7 | 0 | 0 |
| Increased CPK | 9 | 24.3 | 2 | 5.4 | 1 | 2.7 |
Abbreviations: AP, alkaline phosphatase; Cr, creatinine; CPK, creatine phosphokinase; CTCAE, Common Terminology Criteria for Adverse Events; GGT, gamma-glutamyltransferase.
*
GGT.