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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108851253 | 10885125 | 3 | F | 2015 | 20160906 | 20150304 | 20160912 | EXP | BR-ABBVIE-15K-020-1340529-00 | ABBVIE | 40.57 | YR | M | Y | 78.00000 | KG | 20160912 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108851253 | 10885125 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | WEEK 0 | Y | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 108851253 | 10885125 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | WEEK 2 | Y | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 108851253 | 10885125 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | WEEK 3 | Y | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 108851253 | 10885125 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 108851253 | 10885125 | 5 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | 150 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108851253 | 10885125 | 1 | Crohn's disease |
| 108851253 | 10885125 | 5 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108851253 | 10885125 | OT |
| 108851253 | 10885125 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108851253 | 10885125 | Diarrhoea | |
| 108851253 | 10885125 | Gastrointestinal inflammation | |
| 108851253 | 10885125 | Nausea | |
| 108851253 | 10885125 | Post procedural fistula | |
| 108851253 | 10885125 | Purulence |
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 |
|---|---|---|---|---|---|---|
| 108851253 | 10885125 | 1 | 20141231 | 20141231 | 0 | |
| 108851253 | 10885125 | 2 | 201501 | 201501 | 0 | |
| 108851253 | 10885125 | 3 | 201501 | 0 | ||
| 108851253 | 10885125 | 4 | 2015 | 0 |