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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126404131 | 12640413 | 1 | I | 2012 | 20160727 | 20160810 | 20160810 | EXP | BE-AUROBINDO-AUR-APL-2016-10187 | AUROBINDO | ROCHE NA, BLONDEEL PN, VERMEERSCH HF, PEETERS PC, LEMMENS GM, DE CUBBER J ET AL. LONG. 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. 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126404131 | 12640413 | 1 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | U | U | 0 | 500 | MG | BID | |||||||
| 126404131 | 12640413 | 2 | PS | VORICONAZOLE 200 MG | VORICONAZOLE | 1 | Oral | 200 MG, TWO TIMES A DAY | U | 206837 | 200 | MG | BID | ||||||
| 126404131 | 12640413 | 3 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 126404131 | 12640413 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 4 MG, UNK | U | 0 | 4 | MG | ||||||||
| 126404131 | 12640413 | 5 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 500 MG, UNK | U | 0 | 500 | MG | |||||||
| 126404131 | 12640413 | 6 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | UNK | U | 0 | ||||||||||
| 126404131 | 12640413 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | U | U | 0 | .5 | MG | BID | |||||||
| 126404131 | 12640413 | 8 | C | SULFAMETHOXAZOLE 400mg, TRIMETHOPRIM 80mg | 2 | Oral | 0 | ||||||||||||
| 126404131 | 12640413 | 9 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | BID | ||||||||
| 126404131 | 12640413 | 10 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Oral | 0 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126404131 | 12640413 | 1 | Immunosuppression |
| 126404131 | 12640413 | 2 | Aspergilloma |
| 126404131 | 12640413 | 3 | Immunosuppression |
| 126404131 | 12640413 | 4 | Transplant rejection |
| 126404131 | 12640413 | 7 | Immunosuppression |
| 126404131 | 12640413 | 8 | Pseudomonas infection |
| 126404131 | 12640413 | 9 | Glucose tolerance impaired |
| 126404131 | 12640413 | 10 | Sinusitis bacterial |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126404131 | 12640413 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126404131 | 12640413 | Inappropriate antidiuretic hormone secretion | |
| 126404131 | 12640413 | Thoracic vertebral fracture |
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 |
|---|---|---|---|---|---|---|
| 126404131 | 12640413 | 2 | 2012 | 2012 | 0 | |
| 126404131 | 12640413 | 5 | 2012 | 0 | ||
| 126404131 | 12640413 | 9 | 2012 | 0 | ||
| 126404131 | 12640413 | 10 | 2012 | 0 |