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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126457961 | 12645796 | 1 | I | 20160106 | 20160107 | 20160811 | 20160811 | PER | US-ENDO PHARMACEUTICALS INC.-2016-000433 | ENDO | 65.05 | YR | F | Y | 63.56000 | KG | 20160811 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126457961 | 12645796 | 1 | PS | PREDNISONE TABLETS | PREDNISONE | 1 | Oral | S016P15 | 40256 | TABLETS | |||||||||
| 126457961 | 12645796 | 2 | SS | PREDNISONE TABLETS | PREDNISONE | 1 | S016P15 | 40256 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126457961 | 12645796 | 1 | Inflammation |
| 126457961 | 12645796 | 2 | Ear infection |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126457961 | 12645796 | Incorrect dose administered | |
| 126457961 | 12645796 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 126457961 | 12645796 | 1 | 20160106 | 0 |