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The MTD population included all enrolled patients who completed cycle 1 or discontinued during cycle 1 due to a DLT.
All sites completed both cycles of PDSA, although some actions were discontinued in cycle two due to the limited progress made or other changes happening outside of the study.
One lipegfilgrastim 3.0-mg patient discontinued in cycle 3 because of pyrexia, one lipegfilgrastim 4.5-mg patient discontinued in cycle 2 because of pneumonia, and one lipegfilgrastim 4.5-mg patient discontinued in cycle 3 because of thrombocytopenia, FN, mucosal inflammation, and hemorrhagic disorder.
Cetuximab was discontinued after cycle 1 with progression by CT.
Cetuximab was discontinued after cycle 1 in patients with progression by CT.
PCV was discontinued after cycle 1 in three cases, and treatment continued with temozolomide (2) or radiotherapy (1).
Of these patients, one pegfilgrastim patient discontinued in cycle 1 because of headache, malaise, and discomfort; however, the main reason for discontinuation was withdrawal of informed consent.
Patients were excluded from the MTD-evaluable population if they had discontinued during cycle 1 for reasons other than DLTs or had received alternate antineoplastic therapies during that period.
Six patients discontinued two cycles of adjuvant chemotherapy due to patient refusal (n = 1) or adverse events (n = 5).
Considering the discontinuation rate by cycle, 15 women discontinued the study after cycle 1, 8 women after cycle 2, 7 women after cycle 3 and 2 women after cycle 4.
He said he was determined to discontinue the cycle of abuse he experienced in his family.
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