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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126446931 | 12644693 | 1 | I | 2015 | 20150929 | 20160811 | 20160811 | PER | US-ENDO PHARMACEUTICALS INC.-2015-003121 | ENDO | 22.00 | YR | M | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126446931 | 12644693 | 1 | PS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | U | UNKNOWN | 40256 | TABLETS | ||||||||
| 126446931 | 12644693 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126446931 | 12644693 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126446931 | 12644693 | 1 | Crohn's disease |
| 126446931 | 12644693 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126446931 | 12644693 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126446931 | 12644693 | Adrenal insufficiency | |
| 126446931 | 12644693 | Depression | |
| 126446931 | 12644693 | Discomfort | |
| 126446931 | 12644693 | Pain | |
| 126446931 | 12644693 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126446931 | 12644693 | 2 | 20150808 | 0 | ||
| 126446931 | 12644693 | 3 | 2015 | 0 |