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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118856632 | 11885663 | 2 | F | 201508 | 20160624 | 20160104 | 20160701 | EXP | BR-ABBVIE-15K-020-1530503-00 | ABBVIE | 54.31 | YR | F | Y | 57.00000 | KG | 20160701 | CN | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118856632 | 11885663 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE, WEEK 0 | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 118856632 | 11885663 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE, WEEK 2 | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 118856632 | 11885663 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | MAINTENANCE DOSE | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 118856632 | 11885663 | 4 | C | PREDNISONE. | PREDNISONE | 1 | ITS SUPPOSED TO TAKE IT UNTIL 31 DEC 15 | 0 | TABLET | ||||||||||
| 118856632 | 11885663 | 5 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | TABLET | ||||||||||
| 118856632 | 11885663 | 6 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118856632 | 11885663 | 1 | Crohn's disease |
| 118856632 | 11885663 | 4 | Product used for unknown indication |
| 118856632 | 11885663 | 5 | Immunosuppression |
| 118856632 | 11885663 | 6 | Supplementation therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118856632 | 11885663 | OT |
| 118856632 | 11885663 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118856632 | 11885663 | Abdominal pain | |
| 118856632 | 11885663 | Gastrointestinal inflammation | |
| 118856632 | 11885663 | Small intestinal obstruction |
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 |
|---|---|---|---|---|---|---|
| 118856632 | 11885663 | 1 | 20150724 | 20150724 | 0 | |
| 118856632 | 11885663 | 2 | 201508 | 201508 | 0 | |
| 118856632 | 11885663 | 3 | 2015 | 0 | ||
| 118856632 | 11885663 | 5 | 2014 | 0 |