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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126396071 | 12639607 | 1 | I | 2012 | 20151019 | 20160810 | 20160810 | EXP | BE-MLMSERVICE-20160721-0358575-1 | BE-ACCORD-042975 | ACCORD | 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):2038-2046. | 55.00 | YR | M | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126396071 | 12639607 | 1 | PS | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | U | 65416 | 500 | MG | BID | ||||||||
| 126396071 | 12639607 | 2 | I | TACROLIMUS. | TACROLIMUS | 1 | U | 91195 | .5 | MG | BID | ||||||||
| 126396071 | 12639607 | 3 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | PREVIOUSLY RECEIVED INTRAVENOUS FOR 4 DAYS AND THEN DOSE REDUCED TO 4 MG. | U | 0 | 4 | MG | ||||||||
| 126396071 | 12639607 | 4 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 0 | 200 | MG | BID | ||||||||
| 126396071 | 12639607 | 5 | SS | POSACONAZOLE | POSACONAZOLE | 1 | Oral | 0 | 400 | MG | BID | ||||||||
| 126396071 | 12639607 | 6 | SS | ABELCET | AMPHOTERICIN BDIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- | 1 | Intravenous (not otherwise specified) | 0 | 5 | MG/KG | |||||||||
| 126396071 | 12639607 | 7 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Oral | 0 | 100 | MG | |||||||||
| 126396071 | 12639607 | 8 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | SULFAMETHOXAZOLE 400 MG, ?TRIMETHOPRIM 80 MG | 0 | BID | |||||||||
| 126396071 | 12639607 | 9 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | BID | ||||||||
| 126396071 | 12639607 | 10 | C | CASPOFUNGIN | CASPOFUNGIN | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | |||||||||
| 126396071 | 12639607 | 11 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Oral | 0 | 500 | MG | BID | ||||||||
| 126396071 | 12639607 | 12 | C | ZOLEDRONIC ACID | ZOLEDRONIC ACID | 1 | 0 | ||||||||||||
| 126396071 | 12639607 | 13 | C | AMPHOTERICIN B. | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | 0 | 3 | MG/KG | |||||||||
| 126396071 | 12639607 | 14 | I | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | 0 | ||||||||||||
| 126396071 | 12639607 | 15 | I | FENTANYL. | FENTANYL | 1 | Transdermal | DOSAGE FORM: PATCHES | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126396071 | 12639607 | 1 | Immunosuppression |
| 126396071 | 12639607 | 2 | Immunosuppression |
| 126396071 | 12639607 | 3 | Immunosuppression |
| 126396071 | 12639607 | 4 | Aspergillus infection |
| 126396071 | 12639607 | 5 | Aspergilloma |
| 126396071 | 12639607 | 6 | Aspergilloma |
| 126396071 | 12639607 | 7 | Aspergillus infection |
| 126396071 | 12639607 | 8 | Pseudomonas infection |
| 126396071 | 12639607 | 9 | Glucose tolerance impaired |
| 126396071 | 12639607 | 10 | Aspergillus infection |
| 126396071 | 12639607 | 11 | Sinusitis bacterial |
| 126396071 | 12639607 | 12 | Thoracic vertebral fracture |
| 126396071 | 12639607 | 14 | Product used for unknown indication |
| 126396071 | 12639607 | 15 | Thoracic vertebral fracture |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126396071 | 12639607 | LT |
| 126396071 | 12639607 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126396071 | 12639607 | Abscess jaw | |
| 126396071 | 12639607 | Aspergilloma | |
| 126396071 | 12639607 | Aspergillus infection | |
| 126396071 | 12639607 | Cytomegalovirus viraemia | |
| 126396071 | 12639607 | Drug interaction | |
| 126396071 | 12639607 | Glucose tolerance impaired | |
| 126396071 | 12639607 | Inappropriate antidiuretic hormone secretion | |
| 126396071 | 12639607 | Nephropathy toxic | |
| 126396071 | 12639607 | Pneumonia pseudomonal | |
| 126396071 | 12639607 | Pseudomonas infection | |
| 126396071 | 12639607 | Sinusitis bacterial | |
| 126396071 | 12639607 | Stupor | |
| 126396071 | 12639607 | Thoracic vertebral fracture | |
| 126396071 | 12639607 | 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 |
|---|---|---|---|---|---|---|
| 126396071 | 12639607 | 4 | 2012 | 2012 | 0 | |
| 126396071 | 12639607 | 5 | 2012 | 2012 | 0 | |
| 126396071 | 12639607 | 6 | 2012 | 2012 | 0 | |
| 126396071 | 12639607 | 9 | 2012 | 0 | ||
| 126396071 | 12639607 | 10 | 2012 | 2012 | 0 | |
| 126396071 | 12639607 | 11 | 2012 | 0 | ||
| 126396071 | 12639607 | 12 | 2012 | 0 | ||
| 126396071 | 12639607 | 13 | 2012 | 0 | ||
| 126396071 | 12639607 | 14 | 2012 | 2012 | 0 | |
| 126396071 | 12639607 | 15 | 2012 | 2012 | 0 |