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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126627611 | 12662761 | 1 | I | 20160602 | 20160818 | 20160818 | EXP | US-STRIDES ARCOLAB LIMITED-2016SP005899 | STRIDES | BARBAS AS, REGE AS, CASTLEBERRY AW, GOMMER J, ELLIS MJ, BRENNAN TV, COLLINS BH, MARTIN AE, RAVINDRA KV, VIKRAMAN DS, SUDAN DL.. POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME INDEPENDENTLY ASSOCIATED WITH SIROLIMUS AFTER MULTIVISCERAL TRANSPLANTATION.. AM J TRANSPLANT.. 2013;13:808?810 | 0.00 | Y | 0.00000 | 20160818 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126627611 | 12662761 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | UNK | 90687 | |||||||||||
| 126627611 | 12662761 | 2 | SS | SIROLIMUS. | SIROLIMUS | 1 | UNK | 0 | |||||||||||
| 126627611 | 12662761 | 3 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | UNK | 0 | |||||||||||
| 126627611 | 12662761 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | 0 | |||||||||||
| 126627611 | 12662761 | 5 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126627611 | 12662761 | 1 | Immunosuppression |
| 126627611 | 12662761 | 2 | Immunosuppression |
| 126627611 | 12662761 | 3 | Immunosuppression |
| 126627611 | 12662761 | 4 | Immunosuppression |
| 126627611 | 12662761 | 5 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126627611 | 12662761 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126627611 | 12662761 | Coma | |
| 126627611 | 12662761 | Confusional state | |
| 126627611 | 12662761 | Headache | |
| 126627611 | 12662761 | Hypertension | |
| 126627611 | 12662761 | Lethargy | |
| 126627611 | 12662761 | Mental status changes | |
| 126627611 | 12662761 | Nausea | |
| 126627611 | 12662761 | Posterior reversible encephalopathy syndrome | |
| 126627611 | 12662761 | Renal failure | |
| 126627611 | 12662761 | Seizure | |
| 126627611 | 12662761 | Visual impairment |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |