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Table 2 Hematological and non-hematological criteria for suggested dose modification of mycophenolate mofetil

From: Phase II, multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Mycophenolate Mofetil in patients with high-grade locally advanced or metastatic osteosarcoma (ESMMO): rationale and design of the ESMMO trial

Toxicity(a)Hold study treatmentDose modification
Hematological criteria
 Grade 4 bone marrow hypocellularNo(b)Decrease one dose level(c)
 Grade 4 febrile neutropeniaNo(b)Decrease one dose level(c)
 Grade 4 neutrophil count decreasedNo(b)Decrease one dose level(c)
  ≥ Grade 3 of other hematologic toxicitiesNo(b)Decrease one dose level(c)
 Sepsis & any Grade 3 infectionYes until ≤ Grade 2(d)Resume at one dose level lower(c)
 Sepsis & any Grade 4 infectionYes until ≤ Grade 2(d)Resume at two dose level lower(c)
Non-hematological criteria
 Grade 3, except for: delayed puberty, growth suppression, breast atrophy, erectile dysfunction, diarrhea(e), vomiting(e), and AST/ALT increased or other biochemical laboratory abnormalities without any clinically significant sequelaeNo(b)Decrease one dose level(c)
 Any Grade 4 toxicityNo(b)Decrease two dose level(c)
  1. (a) If no recovery (until ≤ Grade 2) is noted after 7 days of dose modification of mycophenolate mofetil, that event will be considered as another toxicity requiring one more dose reduction; (b) Study treatment may be held whenever clinically needed (at the discretion of the PI and study team); (c) If more than 3 dose reductions are required, study treatment may be discontinued unless there is reasonable evidence of clinical benefit to justify continuation in the study; (d) If no recovery (until ≤ Grade 2) is noted after a 28-day delay, study treatment will be discontinued unless there is reasonable evidence of clinical benefit to justify continuation in the study; (e) Only if it occurs despite maximal medical treatment
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