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Table 4 Additional visits and assessments in the extension period

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

Procedures Study Visits
C5w2 C5w4 C6w2 C6w4 C7w2 C7w4 Cxw2 Cxw4 FV
Physical examination × × × × × × × × ×
Lab test for complete blood count × × × × × × × × ×
Other lab tests(a)   ×   ×   ×   × ×
Circulating tumor cells ×   ×   ×   ×   
Biobank collection   ×   ×   ×   × ×
Urine analysis(b)   ×   ×   ×   × ×
PK study(c)          
Pain score & Quality of life   ×   ×   ×   × ×
Review of concomitant medications × × × × × × × × ×
Monitoring for AEs × × × × × × × × ×
Tumor assessment(d)       ×    
  1. Cxwy = cycle x week y; FV = final visit. (a) Lab tests include Na, K, Cl, HCO3, Ca, Mg, P, albumin, AST, ALT, ALP, total bilirubin, direct bilirubin, BUN, Cr, PT, PTT, INR, and LDH; (b) Urine analysis includes a urine pregnancy test for a female patient of childbearing age; (c) Additional samplings for drug monitoring (at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 h) may be required when drug dosage is modified (after ≥7 days of drug administration with an adjusted dose level); (d) Tumor assessment by a CT scan (of the chest ± other organs, if required) or MRI, done at 12-week interval (±1 week); in case of objective tumor response (complete response or partial response), confirmatory imaging studies will be performed at least 4 weeks after initial documentation of response