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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126195111 | 12619511 | 1 | I | 2012 | 20150416 | 20160803 | 20160803 | EXP | BE-ASTELLAS-2015US012881 | ASTELLAS | ROCHE NA, BLONDEEL PN, VERMEERSCH HF, PEETERS PC, LEMMENS GM, DE CUBBER J, ET AL.. LONG-TERM MULTIFUNCTIONAL OUTCOME AND RISKS OF FACE VASCULARIZED COMPOSITE ALLOTRANSPLANTATION. THE JOURNAL OF CRANIOFACIAL SURGERY. 2015;26(7):2038-46 | 55.00 | YR | M | Y | 0.00000 | 20160803 | OT | GB | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126195111 | 12619511 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0.5 MG, TWICE DAILY | U | 50708 | .5 | MG | FORMULATION UNKNOWN | BID | |||||
| 126195111 | 12619511 | 2 | I | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 0 | 1 | G | FORMULATION UNKNOWN | BID | ||||||
| 126195111 | 12619511 | 3 | I | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 500 MG, UNK | U | 0 | 500 | MG | FORMULATION UNKNOWN | BID | |||||
| 126195111 | 12619511 | 4 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 500 | MG | FORMULATION UNKNOWN | QD | |||||||
| 126195111 | 12619511 | 5 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | 8 | MG | FORMULATION UNKNOWN | QD | ||||||
| 126195111 | 12619511 | 6 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | 4 | MG | FORMULATION UNKNOWN | QD | ||||||
| 126195111 | 12619511 | 7 | SS | POSACONAZOLE | POSACONAZOLE | 1 | Unknown | U | 0 | 400 | MG | FORMULATION UNKNOWN | BID | ||||||
| 126195111 | 12619511 | 8 | SS | POSACONAZOLE | POSACONAZOLE | 1 | Unknown | U | 0 | 400 | MG | FORMULATION UNKNOWN | BID | ||||||
| 126195111 | 12619511 | 9 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | Y | 0 | 200 | MG | FORMULATION UNKNOWN | BID | ||||||
| 126195111 | 12619511 | 10 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | U | 0 | 200 | MG | FORMULATION UNKNOWN | BID | ||||||
| 126195111 | 12619511 | 11 | I | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126195111 | 12619511 | 12 | I | FENTANYL /00174602/ | FENTANYL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126195111 | 12619511 | 13 | SS | ABELCET | AMPHOTERICIN BDIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- | 1 | Intravenous (not otherwise specified) | U | 0 | 5 | MG/KG | FORMULATION UNKNOWN | |||||||
| 126195111 | 12619511 | 14 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 400/80 MG, ONCE DAILY | U | 0 | FORMULATION UNKNOWN | QD | |||||||
| 126195111 | 12619511 | 15 | C | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Unknown | U | 0 | 900 | MG | FORMULATION UNKNOWN | |||||||
| 126195111 | 12619511 | 16 | C | CASPOFUNGIN | CASPOFUNGIN | 1 | Intravenous (not otherwise specified) | U | 0 | 50 | MG | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126195111 | 12619511 | 1 | Transplant |
| 126195111 | 12619511 | 2 | Transplant |
| 126195111 | 12619511 | 4 | Transplant |
| 126195111 | 12619511 | 7 | Aspergilloma |
| 126195111 | 12619511 | 9 | Abscess jaw |
| 126195111 | 12619511 | 11 | Product used for unknown indication |
| 126195111 | 12619511 | 12 | Product used for unknown indication |
| 126195111 | 12619511 | 13 | Aspergilloma |
| 126195111 | 12619511 | 14 | Infection prophylaxis |
| 126195111 | 12619511 | 15 | Infection prophylaxis |
| 126195111 | 12619511 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126195111 | 12619511 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126195111 | 12619511 | Abscess jaw | |
| 126195111 | 12619511 | Aspergilloma | |
| 126195111 | 12619511 | Aspergillus infection | |
| 126195111 | 12619511 | Cellulitis orbital | |
| 126195111 | 12619511 | Cytomegalovirus viraemia | |
| 126195111 | 12619511 | Drug interaction | |
| 126195111 | 12619511 | Glucose tolerance impaired | |
| 126195111 | 12619511 | Hyponatraemia | |
| 126195111 | 12619511 | Inappropriate antidiuretic hormone secretion | |
| 126195111 | 12619511 | Nephropathy toxic | |
| 126195111 | 12619511 | Off label use | |
| 126195111 | 12619511 | Osteoporosis | |
| 126195111 | 12619511 | Pneumonia pseudomonal | |
| 126195111 | 12619511 | Pseudomonas infection | |
| 126195111 | 12619511 | Sinusitis bacterial | |
| 126195111 | 12619511 | Stupor | |
| 126195111 | 12619511 | Thoracic vertebral fracture | |
| 126195111 | 12619511 | Transplant rejection |
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 |
|---|---|---|---|---|---|---|
| 126195111 | 12619511 | 1 | 2012 | 0 | ||
| 126195111 | 12619511 | 2 | 2012 | 0 | ||
| 126195111 | 12619511 | 4 | 2012 | 0 | ||
| 126195111 | 12619511 | 7 | 2012 | 0 | ||
| 126195111 | 12619511 | 9 | 2012 | 0 | ||
| 126195111 | 12619511 | 11 | 2012 | 0 | ||
| 126195111 | 12619511 | 12 | 2012 | 0 | ||
| 126195111 | 12619511 | 13 | 2012 | 0 | ||
| 126195111 | 12619511 | 14 | 2012 | 0 | ||
| 126195111 | 12619511 | 15 | 2012 | 0 | ||
| 126195111 | 12619511 | 16 | 2012 | 0 |