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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126204241 | 12620424 | 1 | I | 2012 | 20160720 | 20160803 | 20160803 | EXP | BE-ROCHE-1806970 | ROCHE | ROCHE N, BLONDEEL P, VERMEERSCH H, PEETERS P, LEMMENS G, DE CUBBER J ET AL. LONG-TERM MULTIFUNCTIONAL OUTCOME AND RISKS OF FACE VASCULARIZED COMPOSITE ALLOTRANSPLANTATION. THE JOURNAL OF CRANIOFACIAL SURGERY 2015;26(7):2038-2046. | 55.00 | YR | M | Y | 0.00000 | 20160804 | MD | BE | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126204241 | 12620424 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | ON DAY 21 AFTER FACIAL TRANSPLANATION | U | 50722 | 500 | MG | BID | ||||||
| 126204241 | 12620424 | 2 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 0 | |||||||||||
| 126204241 | 12620424 | 3 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 126204241 | 12620424 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 0 | |||||||||||
| 126204241 | 12620424 | 5 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 0 | 500 | MG | |||||||||
| 126204241 | 12620424 | 6 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 500 | MG | |||||||||
| 126204241 | 12620424 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 0 | .5 | MG | BID | |||||||
| 126204241 | 12620424 | 8 | SS | POSACONAZOLE | POSACONAZOLE | 1 | Oral | 0 | 400 | MG | BID | ||||||||
| 126204241 | 12620424 | 9 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 0 | 200 | MG | BID | ||||||||
| 126204241 | 12620424 | 10 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 0 | 200 | MG | BID | ||||||||
| 126204241 | 12620424 | 11 | I | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | 0 | 4 | MG | |||||||||
| 126204241 | 12620424 | 12 | I | FENTANYL. | FENTANYL | 1 | Unknown | 0 | |||||||||||
| 126204241 | 12620424 | 13 | SS | ABELCET | AMPHOTERICIN BDIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- | 1 | Intravenous (not otherwise specified) | 0 | 5 | MG/KG | |||||||||
| 126204241 | 12620424 | 14 | C | LIPOSOMAL AMPHOTERICIN B | AMPHOTERICIN B | 1 | Unknown | 0 | 3 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126204241 | 12620424 | 1 | Immunosuppression |
| 126204241 | 12620424 | 2 | Immunosuppression |
| 126204241 | 12620424 | 3 | Immunosuppression |
| 126204241 | 12620424 | 7 | Immunosuppression |
| 126204241 | 12620424 | 8 | Aspergilloma |
| 126204241 | 12620424 | 9 | Aspergillus infection |
| 126204241 | 12620424 | 11 | Product used for unknown indication |
| 126204241 | 12620424 | 12 | Thoracic vertebral fracture |
| 126204241 | 12620424 | 13 | Aspergilloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126204241 | 12620424 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126204241 | 12620424 | Abscess jaw | |
| 126204241 | 12620424 | Aspergillus infection | |
| 126204241 | 12620424 | Bronchopulmonary aspergillosis | |
| 126204241 | 12620424 | Cytomegalovirus viraemia | |
| 126204241 | 12620424 | Drug interaction | |
| 126204241 | 12620424 | Glucose tolerance impaired | |
| 126204241 | 12620424 | Hyponatraemia | |
| 126204241 | 12620424 | Inappropriate antidiuretic hormone secretion | |
| 126204241 | 12620424 | Nephropathy toxic | |
| 126204241 | 12620424 | Osteoporotic fracture | |
| 126204241 | 12620424 | Pneumonia pseudomonal | |
| 126204241 | 12620424 | Pseudomonas infection | |
| 126204241 | 12620424 | Sinusitis bacterial | |
| 126204241 | 12620424 | Stupor |
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 |
|---|---|---|---|---|---|---|
| 126204241 | 12620424 | 8 | 2012 | 0 | ||
| 126204241 | 12620424 | 9 | 2012 | 2012 | 0 | |
| 126204241 | 12620424 | 10 | 2012 | 2012 | 0 | |
| 126204241 | 12620424 | 12 | 2012 | 0 | ||
| 126204241 | 12620424 | 13 | 2012 | 2012 | 0 | |
| 126204241 | 12620424 | 14 | 2012 | 0 |