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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113768042 | 11376804 | 2 | F | 2012 | 20160720 | 20150813 | 20160804 | EXP | BE-JNJFOC-20150802857 | JANSSEN | LEMMENS GM, POPPE C, HENDRICKX H, ROCHE NA, PEETERS PC, VERMEERSCH HF, ET AL. FACIAL TRANSPLANTATION IN A BLIND PATIENT: PSYCHOLOGIC, MARITAL, AND FAMILY OUTCOMES AT 15 MONTHS FOLLOW-UP. PSYCHOSOMATICS 2015;56 (4):362-370. ROCHE NA, BLONDEEL PN, VERMEERSCH HF, PEETERS PC, GILBERT LM, DE CUBBER J. LONG-TERM MULTIFUNCTIONAL OUTCOME AND RISKS OF FACE VASCULARIZED COMPOSITE ALLOTRANSPLANTATION. THE JOURNAL OF CRANIOFACIAL SURGERY 2015;26 (7):2038-20146. | 54.00 | YR | A | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113768042 | 11376804 | 1 | PS | FENTANYL. | FENTANYL | 1 | Transdermal | Y | N | 19813 | UNSPECIFIED | ||||||||
| 113768042 | 11376804 | 2 | I | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 113768042 | 11376804 | 3 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | Y | 0 | UNSPECIFIED | |||||||||
| 113768042 | 11376804 | 4 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | Y | 0 | 500 | MG | UNSPECIFIED | |||||||
| 113768042 | 11376804 | 5 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | Y | 0 | UNSPECIFIED | |||||||||
| 113768042 | 11376804 | 6 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | Y | 0 | 500 | MG | UNSPECIFIED | |||||||
| 113768042 | 11376804 | 7 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | U | 0 | 4 | MG | UNSPECIFIED | |||||||
| 113768042 | 11376804 | 8 | I | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 0 | 500 | MG | UNSPECIFIED | BID | ||||||
| 113768042 | 11376804 | 9 | I | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 0 | .5 | MG | UNSPECIFIED | BID | ||||||
| 113768042 | 11376804 | 10 | C | ZOLEDRONIC ACID | ZOLEDRONIC ACID | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113768042 | 11376804 | 11 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 113768042 | 11376804 | 12 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | 500 | MG | UNKNOWN | BID | |||||||
| 113768042 | 11376804 | 13 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | 0 | 500 | MG | UNSPECIFIED | BID | |||||||
| 113768042 | 11376804 | 14 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113768042 | 11376804 | 15 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113768042 | 11376804 | 16 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113768042 | 11376804 | 17 | C | CASPOFUNGIN | CASPOFUNGIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113768042 | 11376804 | 18 | C | POSACONAZOLE | POSACONAZOLE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113768042 | 11376804 | 1 | Fracture pain |
| 113768042 | 11376804 | 2 | Product used for unknown indication |
| 113768042 | 11376804 | 3 | Transplant rejection |
| 113768042 | 11376804 | 4 | Transplant rejection |
| 113768042 | 11376804 | 5 | Immunosuppression |
| 113768042 | 11376804 | 6 | Immunosuppression |
| 113768042 | 11376804 | 7 | Immunosuppression |
| 113768042 | 11376804 | 8 | Immunosuppression |
| 113768042 | 11376804 | 9 | Immunosuppression |
| 113768042 | 11376804 | 10 | Product used for unknown indication |
| 113768042 | 11376804 | 11 | Product used for unknown indication |
| 113768042 | 11376804 | 12 | Product used for unknown indication |
| 113768042 | 11376804 | 13 | Product used for unknown indication |
| 113768042 | 11376804 | 14 | Aspergillus infection |
| 113768042 | 11376804 | 15 | Lung operation |
| 113768042 | 11376804 | 16 | Aspergillus infection |
| 113768042 | 11376804 | 17 | Aspergillus infection |
| 113768042 | 11376804 | 18 | Lung operation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113768042 | 11376804 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113768042 | 11376804 | Drug interaction | |
| 113768042 | 11376804 | Inappropriate antidiuretic hormone secretion | |
| 113768042 | 11376804 | 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 |
|---|---|---|---|---|---|---|
| 113768042 | 11376804 | 1 | 2012 | 2012 | 0 | |
| 113768042 | 11376804 | 2 | 2012 | 2012 | 0 | |
| 113768042 | 11376804 | 4 | 2012 | 0 | ||
| 113768042 | 11376804 | 6 | 2012 | 0 | ||
| 113768042 | 11376804 | 14 | 2012 | 0 | ||
| 113768042 | 11376804 | 15 | 2012 | 2012 | 0 | |
| 113768042 | 11376804 | 16 | 2012 | 2012 | 0 | |
| 113768042 | 11376804 | 17 | 2012 | 2012 | 0 | |
| 113768042 | 11376804 | 18 | 2012 | 2012 | 0 |