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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126005252 | 12600525 | 2 | F | 201606 | 20160803 | 20160727 | 20160810 | EXP | US-ABBVIE-16K-163-1679983-00 | ABBVIE | 25.52 | YR | M | Y | 0.00000 | 20160810 | MD | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126005252 | 12600525 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1057030 | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||||||
| 126005252 | 12600525 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1057030 | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | |||||||
| 126005252 | 12600525 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1057030 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | |||||||
| 126005252 | 12600525 | 4 | SS | DICYCLOMINE | DICYCLOMINE HYDROCHLORIDE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 126005252 | 12600525 | 5 | SS | MOTRIN | IBUPROFEN | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 126005252 | 12600525 | 6 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 126005252 | 12600525 | 7 | C | PENTASA | MESALAMINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126005252 | 12600525 | 1 | Crohn's disease |
| 126005252 | 12600525 | 4 | Product used for unknown indication |
| 126005252 | 12600525 | 5 | Product used for unknown indication |
| 126005252 | 12600525 | 6 | Product used for unknown indication |
| 126005252 | 12600525 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126005252 | 12600525 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126005252 | 12600525 | Abdominal pain | |
| 126005252 | 12600525 | Crohn's disease | |
| 126005252 | 12600525 | Depressed mood | |
| 126005252 | 12600525 | Device issue | |
| 126005252 | 12600525 | Drug ineffective | |
| 126005252 | 12600525 | Inappropriate schedule of drug administration | |
| 126005252 | 12600525 | Intentional overdose | |
| 126005252 | 12600525 | Suicide attempt | |
| 126005252 | 12600525 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 126005252 | 12600525 | 2 | 201606 | 201606 | 0 | |
| 126005252 | 12600525 | 3 | 201607 | 201607 | 0 |