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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 78333603 | 7833360 | 3 | F | 20050524 | 20160625 | 20110228 | 20160705 | EXP | PHBS2009AU00885 | SANDOZ | TSANG BK, KERMEEN FD, HOPKINS PM, CHAMBERS DC ET AL.. REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME: DIAGNOSIS AND MANAGEMENT IN THE SETTING OF LUNG TRANSPLANTATION.. INTERNAL MEDICINE JOURNAL. 2010;40 (10):716-25 | 50.00 | YR | M | Y | 0.00000 | 20160705 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 78333603 | 7833360 | 1 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Oral | 400 MG, UNK | Y | U | 0 | 400 | MG | ||||||
| 78333603 | 7833360 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Y | U | 0 | ||||||||||
| 78333603 | 7833360 | 3 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 2 G, UNK | U | 65379 | 2 | G | |||||||
| 78333603 | 7833360 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | U | 65379 | |||||||||||
| 78333603 | 7833360 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | WEANING REGIMEN | U | 0 | |||||||||
| 78333603 | 7833360 | 6 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | U | 0 | |||||||||||
| 78333603 | 7833360 | 7 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 78333603 | 7833360 | 1 | Lung transplant |
| 78333603 | 7833360 | 2 | Immunosuppressant drug therapy |
| 78333603 | 7833360 | 3 | Lung transplant |
| 78333603 | 7833360 | 4 | Immunosuppressant drug therapy |
| 78333603 | 7833360 | 5 | Lung transplant |
| 78333603 | 7833360 | 6 | Immunosuppressant drug therapy |
| 78333603 | 7833360 | 7 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 78333603 | 7833360 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 78333603 | 7833360 | Blood pressure abnormal | |
| 78333603 | 7833360 | Coagulopathy | |
| 78333603 | 7833360 | Complications of transplanted lung | |
| 78333603 | 7833360 | Depressed level of consciousness | |
| 78333603 | 7833360 | Dyskinesia | |
| 78333603 | 7833360 | Haemorrhage | |
| 78333603 | 7833360 | Hypotonia | |
| 78333603 | 7833360 | Immunosuppressant drug level decreased | |
| 78333603 | 7833360 | Pericardial haemorrhage | |
| 78333603 | 7833360 | Posterior reversible encephalopathy syndrome | |
| 78333603 | 7833360 | Restlessness |
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 |
|---|---|---|---|---|---|---|
| 78333603 | 7833360 | 1 | 20050514 | 20050524 | 0 | |
| 78333603 | 7833360 | 3 | 20050514 | 0 | ||
| 78333603 | 7833360 | 5 | 20050514 | 0 |