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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126578751 | 12657875 | 1 | I | 2012 | 20160727 | 20160817 | 20160817 | EXP | PHHY2016BE111984 | SANDOZ | 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):2038-046 | 55.00 | YR | M | Y | 0.00000 | 20160817 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126578751 | 12657875 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0.5 MG, BID | U | 65461 | .5 | MG | BID | ||||||
| 126578751 | 12657875 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 500 MG, BID | U | 0 | 500 | MG | BID | ||||||
| 126578751 | 12657875 | 3 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 200 MG, BID | 0 | 200 | MG | BID | |||||||
| 126578751 | 12657875 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 126578751 | 12657875 | 5 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 500 MG, UNK | 0 | 500 | MG | ||||||||
| 126578751 | 12657875 | 6 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 4 MG, UNK | 0 | 4 | MG | ||||||||
| 126578751 | 12657875 | 7 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 400/80 MG, BID | U | 0 | BID | ||||||||
| 126578751 | 12657875 | 8 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 500 MG, BID | U | 0 | 500 | MG | BID | ||||||
| 126578751 | 12657875 | 9 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Oral | 500 MG, BID | U | 0 | 500 | MG | BID | ||||||
| 126578751 | 12657875 | 10 | C | CYTOMEGALOVIRUS IMMUNE GLOBULIN | 2 | Unknown | 2 G/KG, UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126578751 | 12657875 | 1 | Transplant |
| 126578751 | 12657875 | 2 | Transplant |
| 126578751 | 12657875 | 3 | Aspergillus infection |
| 126578751 | 12657875 | 4 | Transplant |
| 126578751 | 12657875 | 5 | Transplant rejection |
| 126578751 | 12657875 | 7 | Pseudomonas infection |
| 126578751 | 12657875 | 8 | Glucose tolerance impaired |
| 126578751 | 12657875 | 9 | Sinusitis bacterial |
| 126578751 | 12657875 | 10 | Transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126578751 | 12657875 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126578751 | 12657875 | Disease recurrence | |
| 126578751 | 12657875 | Inappropriate antidiuretic hormone secretion |
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 |
|---|---|---|---|---|---|---|
| 126578751 | 12657875 | 3 | 2012 | 2012 | 0 | |
| 126578751 | 12657875 | 5 | 2012 | 0 | ||
| 126578751 | 12657875 | 8 | 2012 | 0 |