0000000000527990
AUTHOR
Andreas H. Groll
Dose Escalation of Caspofungin for Invasive Aspergillosis - A Phase II Trial
Abstract Abstract 2309 Objectives. Treatment of invasive aspergillosis (IA) fails in up to 50% of all cases and the mortality rate is at least 30%. Antifungal combination treatment has not been proven to be beneficial and dose escalation with liposomal amphotericin B did not improve outcome. New approaches are needed for patients with severe immunosuppression. Methods. Escalating high dosages of caspofungin were investigated in IA defined according to modified EORTC/MSG criteria. The tested cohort of patients received 70mg, 100mg, 150mg or 200mg QD, 8 patients each were to receive caspofungin first-line treatment for proven/probable IA for up to 28 days. Dose limiting toxicity was defined a…
Additional file 2 of Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Additional file 2 figure. Hierarchy of MedDra clinically-validated international medical terminology.
Phase II dose escalation study of caspofungin for invasive Aspergillosis.
ABSTRACT Our objective was to evaluate the maximum tolerated dose of caspofungin for invasive aspergillosis (IA). The safety and pharmacokinetics of escalating dosages of caspofungin were investigated in IA. Eight patients each received caspofungin 70, 100, 150, or 200 mg once a day (QD). Dose-limiting toxicity (DLT) was defined as the same non-hematological treatment-related adverse event of grade ≥4 in 2 of 8 patients or ≥3 in 4 of 8 patients in a cohort. A total of 46 patients (median age, 61 years; 21 female; 89% with hematological malignancies) received caspofungin (9, 8, 9, and 20 patients in the 70-, 100-, 150-, and 200-mg cohorts) for a median of 24.5 days. Plasma pharmacokinetics w…
Additional file 2 of Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Additional file 2 figure. Hierarchy of MedDra clinically-validated international medical terminology.
Additional file 1 of Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Additional file 1 figure. Flowchart of the process.
Additional file 4 of Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Additional file 4 Table 2. Concomitant medications administered at the time of “confirmed OI”. Bio: biologic, mtx: methotrexate; ste: systemic steroids; sDMARDs: synthetic disease modifying antirheumatic drugs; *sDMARDs are intendend other than MTX.
Additional file 1 of Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Additional file 1 figure. Flowchart of the process.
Additional file 3 of Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Additional file 3 Table 1. Complete table with the frequency of the 682 infections adjudicated by the SAC. Infections were reported after evaluation of the cases available in Pharmachild compared to the pathogens/presentations in the provisional list approved by the Safety Adjudication Committee (SAC). Data are presented as per the MedDRA High Level Term (HLT) and Preferred Term (PT) sorted by frequencies in descending order (HLT and then PT). *For definition see Step 5.
Additional file 4 of Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Additional file 4 Table 2. Concomitant medications administered at the time of “confirmed OI”. Bio: biologic, mtx: methotrexate; ste: systemic steroids; sDMARDs: synthetic disease modifying antirheumatic drugs; *sDMARDs are intendend other than MTX.
Additional file 3 of Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Additional file 3 Table 1. Complete table with the frequency of the 682 infections adjudicated by the SAC. Infections were reported after evaluation of the cases available in Pharmachild compared to the pathogens/presentations in the provisional list approved by the Safety Adjudication Committee (SAC). Data are presented as per the MedDRA High Level Term (HLT) and Preferred Term (PT) sorted by frequencies in descending order (HLT and then PT). *For definition see Step 5.