Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
UGT1A4*3 genotype and plasma concentration of posaconazole |
Blood samples were drawn at baseline (day 0) for analysis of patients' UGT1A4*3 genotypes and assigned to homozygous, wild-type, and heterozygous genotypes. For posaconazole serum concentrations, blood samples were collected at day 0, 4, 8, 15 and 22. |
From day 0 to day 22 |
|
Secondary |
The incidence of invasive fungal disease (IFD) and the incidence of Aspergillus infection |
Patients who developed invasive fungal infections, aspergillus infections or death related with IFD infections during posaconazole prophylaxis treatment were recorded in accordance with IFD diagnostic guidelines (Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium. Clin Infect Dis. 2020 Sep 12;71(6):1367-1376). |
90 days posaconazole prophylaxis and 7 days after prophylaxis ending |
|
Secondary |
Plasma concentration of the patients who received different dosages of posaconazole as prophylaxis at different time points |
Blood samples were drawn from patients at day 0, 4, 8, 15, and 22 after receiving posaconazole. |
Day 0, 4, 8, 15 and 22 |
|
Secondary |
The influence of other combined medications for posaconazole plasma concentrations |
Blood samples were drawn at day 0, 4, 8, 15 and 22 after receiving posaconazole, while all combined medications during posaconazole prophylaxis were recorded and IFD cases were monitored during the study period. |
Duration of 90-day posaconazole prophylaxis |
|
Secondary |
Effect of GVHD grading on absorption and utilization of posaconazole tablets (plasma concentration) |
Gastrointestinal GVHD grades (I-IV) were recorded according to patient symptoms and posaconazole plasma concentrations were measured using blood samples of each patient after receiving posaconazole tablets at day 0, 4, 8, 15 and 22. |
Duration of 90-day posaconazole prophylaxis |
|
Secondary |
Effect of diarrhea on absorption and utilization of posaconazole tablets (plasma concentration) |
Diarrhea (acute watery diarrhea, acute hemorrhagic diarrhea, persistent diarrhea, and diarrhea with severe malnutrition) was recorded according to patient symptoms, and posaconazole plasma concentrations were measured using blood samples of each patient after receiving posaconazole tablets at day 0, 4, 8, 15 and 22. |
Duration of 90-day posaconazole prophylaxis |
|
Secondary |
Number/Proportion of patients with immunosuppressive agent application and adjustments |
Recording of the number/proportion of patients who received immunosuppressive agents or adjustments of agents. |
Duration of 90-day posaconazole prophylaxis |
|
Secondary |
Measurement and record of neutrophil counts |
Measurement of neutrophils in blood samples of patients. |
Duration of 90-day posaconazole prophylaxis |
|
Secondary |
Measurement and record of duration of neutropenia |
Measurement of duration of neutropenia in blood samples of patients. |
Duration of 90-day posaconazole prophylaxis |
|
Secondary |
Adverse events |
Record of the number, incidence and frequency of adverse events (AE) during the study period and judge whether the AE is drug related, serious, or special interest AE. AE severity is determined according to MedDRA v23.1. |
Duration of 90-day posaconazole prophylaxis |
|