Table 2.
Treatment-emergent, all-causality adverse event and laboratory abnormalities occurring in at least two patients (N = 6)
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |
|---|---|---|---|---|---|
| Adverse event, n | |||||
| Blood and lymphatic system disorders | |||||
| Anemia | 1 | 1 | 0 | 0 | 2 |
| Neutropenia | 0 | 1 | 1 | 1 | 3 |
| Thrombocytopenia | 0 | 1 | 1 | 0 | 2 |
| Nervous system disorders | |||||
| Headache | 3 | 1 | 0 | 0 | 4 |
| Gastrointestinal disorders | |||||
| Diarrhea | 2 | 1 | 0 | 0 | 3 |
| Nausea | 3 | 0 | 0 | 0 | 3 |
| Dyspepsia | 2 | 0 | 0 | 0 | 2 |
| Investigations | |||||
| White blood cell count decreased | 0 | 3 | 0 | 0 | 3 |
| Metabolism and nutrition disorders | |||||
| Decreased appetite | 1 | 1 | 0 | 0 | 2 |
| Musculoskeletal and connective tissue disorders | |||||
| Back pain | 2 | 0 | 0 | 0 | 2 |
| Laboratory abnormalities, n | |||||
| Chemistry | |||||
| Creatinine | 5 | 1 | 0 | 0 | 6 |
| Hyperglycemia | 4 | 1 | 0 | 0 | 5 |
| Aspartate aminotransferase | 3 | 0 | 0 | 0 | 3 |
| Alanine aminotransferase | 2 | 0 | 0 | 0 | 2 |
| Amylase | 2 | 0 | 0 | 0 | 2 |
| Hypermagnesemia | 2 | 0 | 0 | 0 | 2 |
| Hypocalcemia | 2 | 0 | 0 | 0 | 2 |
| Hypoglycemia | 0 | 1 | 1 | 0 | 2 |
| Hypophosphatemia | 1 | 0 | 1 | 0 | 2 |
| Hematology | |||||
| Lymphopenia | 6 | 0 | 0 | 0 | 6 |
| Neutrophils (absolute)* | 0 | 4 | 1 | 1 | 6 |
| White blood cells* | 0 | 6 | 0 | 0 | 6 |
| Platelets* | 3 | 0 | 1 | 0 | 5 |
| Anemia | 2 | 1 | 1 | 0 | 4 |
Maximum CTCAE grade is defined as the maximum CTCAE grade value for the specific ‘Preferred Term’ or laboratory parameter. CTCAE version 4.0 was used. MedDRA (version 20.0) coding dictionary applied
CTCAE common terminology criteria for adverse events, MedDRA medical dictionary for regulatory activities
*Values are for patients with a decrease in the blood cell count