Exact(34)
Failure to recover counts in 4 weeks meant the patient went off study.
In case of a delay of more than 2 weeks, the patient went off study.
When hematologic recovery was not achieved at day 35, the patient went off study.
The drug was discontinued and symptoms resolved, but after treatment with IM862 was resumed his symptoms exacerbated again, leading to definitive cessation of the drug and the patient went off study.
Ten patients were considered not evaluable; that is, eight went off study early because of toxicity, one patient died early because of progressive disease, and in one patient the lesions were too small.
Patient 5 went off study after 2 doses because of disease progression: on day 15, his serum creatinine increased from a baseline of 0.6 mg/dL to 1.3 mg/dL, and his urine protein increased from 151 mg/24 hours to 1840 mg/24 hours.
Similar(26)
When participants withdraw (i.e., go off study), follow-up will be censored at the date of the last visit.
These patients went off-study.
Five (33.3%) patients went off-study for disease progression.
If grade 4 nonhaematological toxicities occurred, patients went off-study.
This patient went off-study, and creatinine levels returned to normal after relief of the obstruction.
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