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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104306313 | 10430631 | 3 | F | 2011 | 20160922 | 20140904 | 20160927 | EXP | CA-ABBVIE-14K-028-1277691-00 | ABBVIE | 0.00 | M | Y | 0.00000 | 20160927 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104306313 | 10430631 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 6042602 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||||
| 104306313 | 10430631 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 6042602 | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | ||||||||
| 104306313 | 10430631 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | UNKNOWN | 0 | 10 | MG | |||||||
| 104306313 | 10430631 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | UNKNOWN | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104306313 | 10430631 | 1 | Crohn's disease |
| 104306313 | 10430631 | 3 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104306313 | 10430631 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104306313 | 10430631 | Abdominal pain | |
| 104306313 | 10430631 | Arthralgia | |
| 104306313 | 10430631 | Crohn's disease | |
| 104306313 | 10430631 | Decreased appetite | |
| 104306313 | 10430631 | Drug ineffective | |
| 104306313 | 10430631 | Foreign body | |
| 104306313 | 10430631 | Gastrointestinal disorder | |
| 104306313 | 10430631 | Hernia | |
| 104306313 | 10430631 | Incision site abscess | |
| 104306313 | 10430631 | Intestinal obstruction | |
| 104306313 | 10430631 | Musculoskeletal stiffness | |
| 104306313 | 10430631 | Nephrolithiasis | |
| 104306313 | 10430631 | Post procedural complication | |
| 104306313 | 10430631 | Postoperative wound infection |
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 |
|---|---|---|---|---|---|---|
| 104306313 | 10430631 | 1 | 20110829 | 0 | ||
| 104306313 | 10430631 | 2 | 2011 | 0 | ||
| 104306313 | 10430631 | 3 | 2006 | 0 | ||
| 104306313 | 10430631 | 4 | 201608 | 0 |