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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124563122 | 12456312 | 2 | F | 2016 | 20160630 | 20160610 | 20160711 | EXP | CA-ABBVIE-16K-028-1644529-00 | ABBVIE | 0.00 | F | Y | 0.00000 | 20160711 | OT | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124563122 | 12456312 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||||
| 124563122 | 12456312 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 124563122 | 12456312 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | TAPERED OFF | U | UNKNOWN | 0 | ||||||||
| 124563122 | 12456312 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124563122 | 12456312 | 1 | Crohn's disease |
| 124563122 | 12456312 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124563122 | 12456312 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124563122 | 12456312 | Asthenia | |
| 124563122 | 12456312 | Blood glucose increased | |
| 124563122 | 12456312 | Drug level increased | |
| 124563122 | 12456312 | Hypertension | |
| 124563122 | 12456312 | Pneumonia | |
| 124563122 | 12456312 | Steroid withdrawal syndrome | |
| 124563122 | 12456312 | Swelling |
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 |
|---|---|---|---|---|---|---|
| 124563122 | 12456312 | 1 | 20160504 | 0 |