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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125999571 | 12599957 | 1 | I | 20160721 | 20160727 | 20160727 | EXP | JP-PFIZER INC-2016357283 | PFIZER | SANO, H.. PROPHYLACTIC ADMINISTRATION OF VORICONAZOLE WITH TWO DIFFERENT DOSES FOR INVASIVE FUNGAL INFECTION IN CHILDREN AND ADOLESCENTS WITH ACUTE MYELOID LEUKEMIA. JOURNAL OF MICROBIOLOGY, IMMUNOLOGY AND INFECTION. 2016;1-7 | 16.00 | YR | M | Y | 0.00000 | 20160727 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125999571 | 12599957 | 1 | PS | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 5 MG/KG, DAILY | U | 21266 | 5 | MG/KG | |||||||
| 125999571 | 12599957 | 2 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 3 | C | CYTARABINE. | CYTARABINE | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 4 | C | GEMTUZUMAB OZOGAMICIN | GEMTUZUMAB OZOGAMICIN | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 5 | C | IDARUBICIN HCL | IDARUBICIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 6 | C | MITOXANTRONE HCL | MITOXANTRONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 7 | C | ETOPOSIDE. | ETOPOSIDE | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 8 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 9 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 10 | C | ACLACINOMYCIN | ACLARUBICIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 11 | C | 6-MERCAPTOPURINE MONOHYDRATE | MERCAPTOPURINE | 1 | 0 | ||||||||||||
| 125999571 | 12599957 | 12 | C | GRANULOCYTE COLONY STIMULATING FACTOR | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125999571 | 12599957 | 1 | Infection prophylaxis |
| 125999571 | 12599957 | 2 | Prophylaxis |
| 125999571 | 12599957 | 3 | Acute myeloid leukaemia |
| 125999571 | 12599957 | 4 | Acute myeloid leukaemia |
| 125999571 | 12599957 | 5 | Acute myeloid leukaemia |
| 125999571 | 12599957 | 6 | Acute myeloid leukaemia |
| 125999571 | 12599957 | 7 | Acute myeloid leukaemia |
| 125999571 | 12599957 | 8 | Acute myeloid leukaemia |
| 125999571 | 12599957 | 9 | Acute myeloid leukaemia |
| 125999571 | 12599957 | 10 | Acute myeloid leukaemia |
| 125999571 | 12599957 | 11 | Acute myeloid leukaemia |
| 125999571 | 12599957 | 12 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125999571 | 12599957 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125999571 | 12599957 | Drug ineffective | |
| 125999571 | 12599957 | Fungal infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |