Adverse events by organ system
| Adverse event . | Mild, no. . | Moderate, no. . | Severe, no. . | Life-threatening, no./no. fatal . | Total, no. . |
|---|---|---|---|---|---|
| Hematologic | |||||
| Anemia | 0 | 1 | 0 | 0 | 1 |
| Thrombocytopenia | 1 | 3 | 0 | 0 | 4 |
| GI | |||||
| Nausea/vomiting | 4 | 5 | 0 | 0 | 9 |
| Diarrhea | 0 | 2 | 0 | 0 | 2 |
| Constipation | 0 | 1 | 0 | 0 | 1 |
| Hepatomegaly | 0 | 1 | 0 | 0 | 1 |
| Hepatitis and pancreatitis | 0 | 0 | 0 | 0/1 | 1 |
| Other GI Symptoms | 2 | 3 | 0 | 0 | 5 |
| CNS | |||||
| Stupor/somnolence | 0 | 2 | 2 | 0 | 4 |
| Confusion/disorientation | 1 | 5 | 1 | 0 | 7 |
| Hypoesthesia | 1 | 0 | 0 | 0 | 1 |
| Hallucination | 0 | 0 | 1 | 0 | 1 |
| Lethargy/fatigue | 1 | 3 | 2 | 0 | 6 |
| Visual changes | 0 | 1 | 0 | 0 | 1 |
| Restlessness | 2 | 1 | 1 | 0 | 4 |
| Headache | 2 | 1 | 0 | 0 | 3 |
| Insomnia | 1 | 0 | 0 | 0 | 1 |
| Rejection of transplanted lung | 0 | 0 | 0 | 0/1 | 1 |
| Metabolic | |||||
| Hypokalemia | 1 | 1 | 1 | 0 | 3 |
| Elevated BUN | 1 | 2 | 1 | 0 | 4 |
| Cardiorespiratory | |||||
| Orthostasis | 1 | 0 | 0 | 0 | 1 |
| Increased dyspnea | 0 | 0 | 1 | 0 | 1 |
| ARDS, pulmonary hemorrhage | 0 | 0 | 0 | 1 | 1 |
| Infectious | |||||
| Pneumonia | 0 | 1 | 0 | 1 | 2 |
| Fungal (noninvasive, GI tract) | 0 | 1 | 0 | 0 | 1 |
| Fever/suspected sepsis | 0 | 0 | 1 | 0 | 1 |
| Staph sepsis, port infection | 0 | 2 | 0 | 0 | 2 |
| Other | |||||
| Back pain | 0 | 1 | 0 | 0 | 1 |
| Sinus pain | 1 | 0 | 0 | 0 | 1 |
| Rash | 1 | 0 | 0 | 0 | 1 |
| Pharyngitis | 0 | 2 | 0 | 0 | 2 |
| Mucositis | 1 | 1 | 0 | 0 | 2 |
| Deep vein thrombosis | 0 | 0 | 1 | 0 | 1 |
| Complications of tumor lysis (hemorrhage or bowel perforation) | 1 | 0 | 0 | 0/2 | 2 |
| Total | 22 | 40 | 12 | 2/4 | 80 |
| Adverse event . | Mild, no. . | Moderate, no. . | Severe, no. . | Life-threatening, no./no. fatal . | Total, no. . |
|---|---|---|---|---|---|
| Hematologic | |||||
| Anemia | 0 | 1 | 0 | 0 | 1 |
| Thrombocytopenia | 1 | 3 | 0 | 0 | 4 |
| GI | |||||
| Nausea/vomiting | 4 | 5 | 0 | 0 | 9 |
| Diarrhea | 0 | 2 | 0 | 0 | 2 |
| Constipation | 0 | 1 | 0 | 0 | 1 |
| Hepatomegaly | 0 | 1 | 0 | 0 | 1 |
| Hepatitis and pancreatitis | 0 | 0 | 0 | 0/1 | 1 |
| Other GI Symptoms | 2 | 3 | 0 | 0 | 5 |
| CNS | |||||
| Stupor/somnolence | 0 | 2 | 2 | 0 | 4 |
| Confusion/disorientation | 1 | 5 | 1 | 0 | 7 |
| Hypoesthesia | 1 | 0 | 0 | 0 | 1 |
| Hallucination | 0 | 0 | 1 | 0 | 1 |
| Lethargy/fatigue | 1 | 3 | 2 | 0 | 6 |
| Visual changes | 0 | 1 | 0 | 0 | 1 |
| Restlessness | 2 | 1 | 1 | 0 | 4 |
| Headache | 2 | 1 | 0 | 0 | 3 |
| Insomnia | 1 | 0 | 0 | 0 | 1 |
| Rejection of transplanted lung | 0 | 0 | 0 | 0/1 | 1 |
| Metabolic | |||||
| Hypokalemia | 1 | 1 | 1 | 0 | 3 |
| Elevated BUN | 1 | 2 | 1 | 0 | 4 |
| Cardiorespiratory | |||||
| Orthostasis | 1 | 0 | 0 | 0 | 1 |
| Increased dyspnea | 0 | 0 | 1 | 0 | 1 |
| ARDS, pulmonary hemorrhage | 0 | 0 | 0 | 1 | 1 |
| Infectious | |||||
| Pneumonia | 0 | 1 | 0 | 1 | 2 |
| Fungal (noninvasive, GI tract) | 0 | 1 | 0 | 0 | 1 |
| Fever/suspected sepsis | 0 | 0 | 1 | 0 | 1 |
| Staph sepsis, port infection | 0 | 2 | 0 | 0 | 2 |
| Other | |||||
| Back pain | 0 | 1 | 0 | 0 | 1 |
| Sinus pain | 1 | 0 | 0 | 0 | 1 |
| Rash | 1 | 0 | 0 | 0 | 1 |
| Pharyngitis | 0 | 2 | 0 | 0 | 2 |
| Mucositis | 1 | 1 | 0 | 0 | 2 |
| Deep vein thrombosis | 0 | 0 | 1 | 0 | 1 |
| Complications of tumor lysis (hemorrhage or bowel perforation) | 1 | 0 | 0 | 0/2 | 2 |
| Total | 22 | 40 | 12 | 2/4 | 80 |
GI indicates gastrointestinal; CNS, central nervous system; BUN, blood urea nitrogen; ARDS, adult respiratory distress syndrome.