Table 1.
Adverse events experienced by more than two patients
| Most frequently reported nonhematologic toxicities (at least two patients) regardless of causality (all cycles, worst toxicity grade by patient) | |||||||
|---|---|---|---|---|---|---|---|
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| Adverse event | No. patients with grade 1–2/3* adverse events | All cohorts | |||||
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| Group A (daily × 5) | Group B (weekly) | ||||||
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| Dose level (μg/kg) | |||||||
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| 100 | 500 | 1,000 | 100 | 1,000 | 2,000 | ||
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| n = 3 | n = 3 | n = 3 | n = 4 | n = 3 | n = 3 | N = 19 | |
| Chills | 2/0 | 3/0 | 3/0 | 3/0 | 2/0 | 3/0 | 16/0 |
| Fever | 2/0 | 3/0 | 1/1 | 3/0 | 2/1 | 2/0 | 13/2 |
| Headache | 1/1 | 3/0 | 3/0 | 2/0 | 1/0 | — | 10/1 |
| Fatigue | 1/0 | 2/0 | 2/0 | 2/0 | 1/0 | 2/0 | 10/0 |
| Pain (back/extremity) | 3/0 | 5/0 | 1/0 | — | 1/0 | — | 10/0 |
| Pruritus/pruritic rash | 1/0 | 3/0 | 2/0 | 2/0 | — | 1/0 | 9/0 |
| Nausea | 2/0 | 2/0 | 2/0 | 1/0 | 1/0 | — | 8/0 |
| Pain | 1/0 | 2/0 | 2/0 | 2/0 | — | 1/0 | 8/0 |
| Myalgia/arthralgia | 2/0 | 1/0 | 1/0 | — | 1/0 | 3/0 | 8/0 |
| Anorexia | 1/0 | 2/0 | — | 1/0 | 2/0 | 1/0 | 7/0 |
| Vomiting | — | 1/0 | 1/0 | 2/0 | 1/0 | 1/0 | 6/0 |
| Diarrhea | 1/0 | 1/0 | 2/0 | 1/0 | 1/0 | — | 6/0 |
| Cough | 1/0 | 1/0 | 2/0 | — | 1/0 | 1/0 | 6/0 |
| Dizziness | 1/0 | 2/0 | — | 1/0 | 1/0 | 1/0 | 6/0 |
| Insomnia | 2/0 | 2/0 | 1/0 | — | — | — | 5/0 |
| Injection site/skin reaction | 1/0 | — | 3/0 | 1/0 | — | — | 5/0 |
| Abdominal pain/distension | 3/0 | — | 1/0 | — | — | 1/0 | 5/0 |
| Chest pain | 1/0 | — | — | 1/0 | 1/0 | 2/0 | 5/0 |
| Rash/urticaria | 1/0 | 2/0 | 1/0 | — | — | 1/0 | 5/0 |
| Paresthesia/hypoesthesia | 1/0 | 1/0 | 1/0 | — | — | 1/0 | 4/0 |
| Hypotension | 1/0 | 1/0 | — | — | 0/1 | 1/0 | 3/1 |
| Hypertension | — | — | 2/0 | — | — | — | 2/0 |
*
No grade 4 adverse events were reported.