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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126578721 | 12657872 | 1 | I | 2012 | 20160727 | 20160817 | 20160817 | EXP | PHHY2016BE111985 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126578721 | 12657872 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0.5 MG, BID | U | 65461 | .5 | MG | BID | ||||||
| 126578721 | 12657872 | 2 | I | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 500 MG, BID | U | 0 | 500 | MG | BID | ||||||
| 126578721 | 12657872 | 3 | I | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | 0 | |||||||||||
| 126578721 | 12657872 | 4 | I | FENTANYL. | FENTANYL | 1 | Transdermal | 0 | PATCH | ||||||||||
| 126578721 | 12657872 | 5 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 126578721 | 12657872 | 6 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 500 MG, UNK | 0 | 500 | MG | ||||||||
| 126578721 | 12657872 | 7 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 4 MG, UNK | 0 | 4 | MG | ||||||||
| 126578721 | 12657872 | 8 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 200 MG, BID | 0 | 200 | MG | BID | |||||||
| 126578721 | 12657872 | 9 | C | POSACONAZOLE | POSACONAZOLE | 1 | Oral | 4 MG, BID | 0 | 4 | MG | BID | |||||||
| 126578721 | 12657872 | 10 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 126578721 | 12657872 | 11 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 400/80 MG, BID | U | 0 | BID | ||||||||
| 126578721 | 12657872 | 12 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 500 MG, BID | U | 0 | 500 | MG | BID | ||||||
| 126578721 | 12657872 | 13 | C | CASPOFUNGIN | CASPOFUNGIN | 1 | Intravenous (not otherwise specified) | 50 MG, UNK | 0 | 50 | MG | ||||||||
| 126578721 | 12657872 | 14 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Oral | 500 MG, BID | U | 0 | 500 | MG | BID | ||||||
| 126578721 | 12657872 | 15 | C | CYTOMEGALOVIRUS IMMUNE GLOBULIN | 2 | Unknown | 2 G/KG, UNK | U | 0 | ||||||||||
| 126578721 | 12657872 | 16 | C | ZOLEDRONIC ACID | ZOLEDRONIC ACID | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126578721 | 12657872 | 1 | Transplant |
| 126578721 | 12657872 | 2 | Transplant |
| 126578721 | 12657872 | 3 | Product used for unknown indication |
| 126578721 | 12657872 | 4 | Thoracic vertebral fracture |
| 126578721 | 12657872 | 5 | Transplant |
| 126578721 | 12657872 | 6 | Transplant rejection |
| 126578721 | 12657872 | 8 | Aspergillus infection |
| 126578721 | 12657872 | 9 | Aspergilloma |
| 126578721 | 12657872 | 10 | Aspergillus infection |
| 126578721 | 12657872 | 11 | Pseudomonas infection |
| 126578721 | 12657872 | 12 | Glucose tolerance impaired |
| 126578721 | 12657872 | 13 | Aspergillus infection |
| 126578721 | 12657872 | 14 | Sinusitis bacterial |
| 126578721 | 12657872 | 15 | Transplant rejection |
| 126578721 | 12657872 | 16 | Thoracic vertebral fracture |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126578721 | 12657872 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126578721 | 12657872 | Drug interaction | |
| 126578721 | 12657872 | Hyponatraemia | |
| 126578721 | 12657872 | 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 |
|---|---|---|---|---|---|---|
| 126578721 | 12657872 | 3 | 2012 | 2012 | 0 | |
| 126578721 | 12657872 | 4 | 2012 | 2012 | 0 | |
| 126578721 | 12657872 | 6 | 2012 | 0 | ||
| 126578721 | 12657872 | 8 | 2012 | 2012 | 0 | |
| 126578721 | 12657872 | 9 | 2012 | 2012 | 0 | |
| 126578721 | 12657872 | 10 | 2012 | 0 | ||
| 126578721 | 12657872 | 12 | 2012 | 0 | ||
| 126578721 | 12657872 | 13 | 2012 | 2012 | 0 | |
| 126578721 | 12657872 | 16 | 2012 | 0 |