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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127327851 | 12732785 | 1 | I | 2012 | 20160902 | 20160912 | 20160912 | EXP | JP-MYLANLABS-2016M1038067 | MYLAN | NANNO S, NAKANE T, OKAMURA H, NISHIMOTO M, KOH H, NAKAMAE H, ET AL. DISSEMINATED HORMOGRAPHIELLA ASPERGILLATA INFECTION WITH INVOLVEMENT OF THE LUNG, BRAIN, AND SMALL INTESTINE FOLLOWING ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: CASE REPORT AND LITERATURE REVIEW. TRANSPL-INFECT-DIS 2016;18(4):611-616. | 0.00 | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127327851 | 12732785 | 1 | PS | MELPHALAN | MELPHALAN | 1 | Unknown | 40 MG/M2 X 2 DAYS; CONDITIONING REGIMEN | 90270 | ||||||||||
| 127327851 | 12732785 | 2 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/M2 X 5 DAYS;CONDITIONING REGIMEN AND 30MG/M2 FOR 1 DAY | 0 | ||||||||||
| 127327851 | 12732785 | 3 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30MG/M2 FOR 1 DAY; 1 DAY REDUCED-INTENSITY CONDITIONING REGIMEN | 0 | ||||||||||
| 127327851 | 12732785 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0.03 MG/KG DAILY | 0 | ||||||||||
| 127327851 | 12732785 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 1500MG DAILY | 0 | ||||||||||
| 127327851 | 12732785 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 2000 MG/M2 X 1 DAY; REDUCED-INTENSITY CONDITIONING REGIMEN | 0 | ||||||||||
| 127327851 | 12732785 | 7 | C | LENOGRASTIM | LENOGRASTIM | 1 | Unknown | FROM DAY 5 AFTER TRANSPLANTATION | 0 | ||||||||||
| 127327851 | 12732785 | 8 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Unknown | FROM DAY 5 AFTER TRANSPLANTATION | 0 | ||||||||||
| 127327851 | 12732785 | 9 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | 0 | |||||||||||
| 127327851 | 12732785 | 10 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127327851 | 12732785 | 1 | Product used for unknown indication |
| 127327851 | 12732785 | 2 | Product used for unknown indication |
| 127327851 | 12732785 | 4 | Prophylaxis against graft versus host disease |
| 127327851 | 12732785 | 5 | Prophylaxis against graft versus host disease |
| 127327851 | 12732785 | 6 | Product used for unknown indication |
| 127327851 | 12732785 | 7 | Product used for unknown indication |
| 127327851 | 12732785 | 8 | Antifungal prophylaxis |
| 127327851 | 12732785 | 9 | Antiviral prophylaxis |
| 127327851 | 12732785 | 10 | Antibiotic prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127327851 | 12732785 | DE |
| 127327851 | 12732785 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127327851 | 12732785 | Aspergillus infection | |
| 127327851 | 12732785 | Brain abscess | |
| 127327851 | 12732785 | Enterococcal sepsis | |
| 127327851 | 12732785 | Histiocytosis haematophagic | |
| 127327851 | 12732785 | Pneumonia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127327851 | 12732785 | 1 | 201210 | 0 | ||
| 127327851 | 12732785 | 2 | 201210 | 0 | ||
| 127327851 | 12732785 | 4 | 201210 | 0 | ||
| 127327851 | 12732785 | 5 | 201210 | 0 | ||
| 127327851 | 12732785 | 6 | 201210 | 0 |