Table 4.
Summary of grade 3/4 treatment-emergent adverse events and serious adverse events.a,b
| Intense (n = 41) | Intermediate (n = 41) | Short (n = 40)c | ||||
|---|---|---|---|---|---|---|
| Event, n (%) | Grade 3/4 | Serious | Grade 3/4 | Serious | Grade 3/4 | Serious |
| Hypertension | 3 (7.3) | 0 | 2 (4.9) | 0 | 1 (2.5) | 0 |
| Hyperglycemia | 1 (2.4) | 1 (2.4) | 2 (4.9) | 0 | 0 | 0 |
| Pneumonia | 1 (2.4) | 2 (4.9) | 1 (2.4) | 1 (2.4) | 1 (2.5) | 1 (2.5) |
| Increased alanine aminotransferase | 1 (2.4) | 0 | 1 (2.4) | 0 | 0 | 0 |
| Diarrhea | 1 (2.4) | 0 | 1 (2.4) | 0 | 0 | 0 |
| Arthralgia | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Atrial fibrillation | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Cardiac failure | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Dehydration | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Hemangioblastoma | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Hemiplegia | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Hypertriglyceridemia | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Leukocytosis | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Pericardial effusion | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Pulmonary embolism | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Streptococcal sepsis | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 0 |
| Increased blood pressure | 1 (2.4) | 0 | 0 | 0 | 0 | 0 |
| Depression | 1 (2.4) | 0 | 0 | 0 | 0 | 0 |
| Dysarthria | 1 (2.4) | 0 | 0 | 0 | 0 | 0 |
| Dyspnea | 1 (2.4) | 0 | 0 | 0 | 0 | 0 |
| Influenza-like illness | 1 (2.4) | 0 | 0 | 0 | 0 | 0 |
| Musculoskeletal disorder | 1 (2.4) | 0 | 0 | 0 | 0 | 0 |
| Thrombocytopenia | 1 (2.4) | 0 | 0 | 0 | 0 | 0 |
| Hip fracture | 0 | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 |
| Hyponatremia | 0 | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 |
| Intestinal perforation | 0 | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 |
| Osteoarthritis | 0 | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 |
| Pain | 0 | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 |
| Anastomotic leak | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Asthma | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Cataract | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Diverticulitis | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Gastrointestinal anastomotic leak | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Hypersensitivity vasculitis | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Lymphopenia | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Angina pectoris | 0 | 0 | 0 | 0 | 1 (2.5) | 1 (2.5) |
| Unstable angina | 0 | 0 | 0 | 0 | 1 (2.5) | 1 (2.5) |
| Sepsis | 0 | 0 | 0 | 0 | 1 (2.5) | 1 (2.5) |
| Abdominal discomfort | 0 | 0 | 0 | 0 | 1 (2.5) | 0 |
| Cough | 0 | 0 | 0 | 0 | 1 (2.5) | 0 |
| Breast disorder | 0 | 1 (2.4) | 0 | 0 | 0 | 0 |
| Embolism | 0 | 1 (2.4) | 0 | 0 | 0 | 0 |
| Fall | 0 | 1 (2.4) | 0 | 0 | 0 | 0 |
| Pleurisy | 0 | 1 (2.4) | 0 | 0 | 0 | 0 |
| Ileus | 0 | 0 | 0 | 1 (2.4) | 0 | 0 |
| Malignant melanoma | 0 | 0 | 0 | 1 (2.4) | 0 | 0 |
aBased on the clinical cutoff date of June 29, 2018.
bThe safety analysis population included patients who were randomized, received at least one dose of study drug, and contributed any safety data after the start of study treatment.
cOne patient in the short arm was randomized but did not receive study treatment.