Person who experienced the adverse event (patient)
Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125348541 | 12534854 | 1 | I | 20160629 | 20160707 | 20160707 | EXP | TW-MYLANLABS-2016M1028024 | MYLAN | LEE S-H, SUN H-Y, KO B-S, CHANG S-C. BREAKTHROUGH INVASIVE FUNGAL INFECTION UNDER THE USE OF POSACONAZOLE AND VORICONAZOLE. J-FORMOS-MED-ASSOC 2016;115(5):384-385. | 0.00 | Y | 0.00000 | 20160707 | OT | TW | TW |
Drug(s) used by person
Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125348541 | 12534854 | 1 | PS | VORICONAZOLE. | VORICONAZOLE | 1 | Unknown | 90547 | |||||||||||
125348541 | 12534854 | 2 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | 90547 | ||||||||||||
125348541 | 12534854 | 3 | SS | POSACONAZOLE | POSACONAZOLE | 1 | Unknown | 0 | |||||||||||
125348541 | 12534854 | 4 | C | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Unknown | 0 | |||||||||||
125348541 | 12534854 | 5 | C | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | 0 | |||||||||||
125348541 | 12534854 | 6 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125348541 | 12534854 | 1 | Systemic mycosis |
125348541 | 12534854 | 2 | Aspergillus infection |
125348541 | 12534854 | 3 | Antifungal prophylaxis |
125348541 | 12534854 | 4 | Prophylaxis against graft versus host disease |
125348541 | 12534854 | 5 | Prophylaxis against graft versus host disease |
125348541 | 12534854 | 6 | Prophylaxis against graft versus host disease |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125348541 | 12534854 | DE |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125348541 | 12534854 | Drug ineffective | |
125348541 | 12534854 | Multiple organ dysfunction syndrome | |
125348541 | 12534854 | Pathogen resistance | |
125348541 | 12534854 | Septic shock |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |