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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124412282 | 12441228 | 2 | F | 201505 | 20160921 | 20160607 | 20160928 | EXP | DE-009507513-1606DEU001856 | MERCK | 73.00 | YR | M | Y | 0.00000 | 20160928 | CN | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124412282 | 12441228 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 40 MG, QD | U | 19766 | 40 | MG | TABLET | QD | |||||
| 124412282 | 12441228 | 2 | I | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | UNK | D | 0 | ||||||||||
| 124412282 | 12441228 | 3 | I | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 20 MG, QD (THERAPY START LONG TERM) | U | 0 | 20 | MG | QD | |||||||
| 124412282 | 12441228 | 4 | I | CYCLOSPORINE. | CYCLOSPORINE | 1 | LONG TERM | U | 0 | ||||||||||
| 124412282 | 12441228 | 5 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 5 MG, UNK | U | 0 | 5 | MG | SUSPENSION FOR INJECTION | |||||||
| 124412282 | 12441228 | 6 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | LONG TERM | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124412282 | 12441228 | 1 | Hypercholesterolaemia |
| 124412282 | 12441228 | 2 | Diarrhoea |
| 124412282 | 12441228 | 3 | Hypertension |
| 124412282 | 12441228 | 4 | Immunosuppressant drug therapy |
| 124412282 | 12441228 | 5 | Immunosuppressant drug therapy |
| 124412282 | 12441228 | 6 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124412282 | 12441228 | OT |
| 124412282 | 12441228 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124412282 | 12441228 | Drug interaction | |
| 124412282 | 12441228 | Rhabdomyolysis |
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 |
|---|---|---|---|---|---|---|
| 124412282 | 12441228 | 2 | 2015 | 0 |