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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102851675 | 10285167 | 5 | F | 2012 | 20160714 | 20140708 | 20160721 | EXP | BR-ABBVIE-14P-020-1256900-00 | ABBVIE | 0.00 | F | Y | 53.00000 | KG | 20160721 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102851675 | 10285167 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | STARTING DOSE | Y | N | UNKNOWN | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 102851675 | 10285167 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | N | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 102851675 | 10285167 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | Y | N | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||
| 102851675 | 10285167 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | N | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 102851675 | 10285167 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | N | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 102851675 | 10285167 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | |||||||||||
| 102851675 | 10285167 | 7 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | 2.5 | DF | TABLET | ||||||||
| 102851675 | 10285167 | 8 | C | MESALAZINE | MESALAMINE | 1 | Rectal | 0 | 250 | MG | SUPPOSITORY | BID | |||||||
| 102851675 | 10285167 | 9 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Intramuscular | 0 | 5 | ML | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 102851675 | 10285167 | 1 | Crohn's disease |
| 102851675 | 10285167 | 6 | Product used for unknown indication |
| 102851675 | 10285167 | 7 | Crohn's disease |
| 102851675 | 10285167 | 8 | Crohn's disease |
| 102851675 | 10285167 | 9 | Vitamin supplementation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 102851675 | 10285167 | HO |
| 102851675 | 10285167 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 102851675 | 10285167 | Abdominal pain | |
| 102851675 | 10285167 | Abdominal pain upper | |
| 102851675 | 10285167 | Diarrhoea | |
| 102851675 | 10285167 | Drug ineffective | |
| 102851675 | 10285167 | Gastrointestinal inflammation | |
| 102851675 | 10285167 | Gastrointestinal stoma complication | |
| 102851675 | 10285167 | Malaise | |
| 102851675 | 10285167 | Nausea | |
| 102851675 | 10285167 | Proctitis | |
| 102851675 | 10285167 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 102851675 | 10285167 | 1 | 2010 | 2012 | 0 | |
| 102851675 | 10285167 | 2 | 2012 | 2012 | 0 | |
| 102851675 | 10285167 | 3 | 20140702 | 20140702 | 0 | |
| 102851675 | 10285167 | 5 | 2016 | 0 | ||
| 102851675 | 10285167 | 7 | 2014 | 0 | ||
| 102851675 | 10285167 | 8 | 2014 | 0 | ||
| 102851675 | 10285167 | 9 | 2013 | 0 |