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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122828952 | 12282895 | 2 | F | 2014 | 20160712 | 20160419 | 20160722 | EXP | BR-ABBVIE-16K-020-1605024-00 | ABBVIE | 0.00 | F | Y | 50.00000 | KG | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122828952 | 12282895 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 122828952 | 12282895 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 122828952 | 12282895 | 3 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | UNKNOWN | 0 | 1 | DF | TABLET | Q8H | ||||||
| 122828952 | 12282895 | 4 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | TABLET | ||||||||||
| 122828952 | 12282895 | 5 | C | DIPYRONE | DIPYRONE | 1 | 0 | 40 | GTT | QID | |||||||||
| 122828952 | 12282895 | 6 | C | DIPYRONE | DIPYRONE | 1 | Oral | AS NEEDED | 0 | 40 | GTT | ORAL DROPS | Q4H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122828952 | 12282895 | 1 | Crohn's disease |
| 122828952 | 12282895 | 3 | Pain |
| 122828952 | 12282895 | 4 | Crohn's disease |
| 122828952 | 12282895 | 5 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122828952 | 12282895 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122828952 | 12282895 | Arthralgia | |
| 122828952 | 12282895 | Asthenia | |
| 122828952 | 12282895 | Chondropathy | |
| 122828952 | 12282895 | Colitis | |
| 122828952 | 12282895 | Depression | |
| 122828952 | 12282895 | Drug ineffective | |
| 122828952 | 12282895 | Frequent bowel movements | |
| 122828952 | 12282895 | Gait disturbance | |
| 122828952 | 12282895 | Gastrointestinal pain | |
| 122828952 | 12282895 | Hypertension | |
| 122828952 | 12282895 | Ileal stenosis | |
| 122828952 | 12282895 | Insomnia | |
| 122828952 | 12282895 | Joint dislocation | |
| 122828952 | 12282895 | Joint range of motion decreased | |
| 122828952 | 12282895 | Memory impairment | |
| 122828952 | 12282895 | Muscular weakness | |
| 122828952 | 12282895 | Osteoarthritis | |
| 122828952 | 12282895 | Osteoporosis | |
| 122828952 | 12282895 | Pain | |
| 122828952 | 12282895 | Visual impairment | |
| 122828952 | 12282895 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 122828952 | 12282895 | 1 | 20131001 | 201602 | 0 | |
| 122828952 | 12282895 | 2 | 201602 | 0 | ||
| 122828952 | 12282895 | 3 | 201606 | 0 | ||
| 122828952 | 12282895 | 4 | 201410 | 0 | ||
| 122828952 | 12282895 | 6 | 2015 | 0 |