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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109282654 | 10928265 | 4 | F | 201502 | 20150922 | 20150319 | 20160920 | EXP | AU-ABBVIE-15K-008-1359523-00 | ABBVIE | 31.05 | YR | M | Y | 0.00000 | 20160920 | MD | COUNTRY NOT SPECIFIED | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109282654 | 10928265 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | UNKNOWN | 125057 | 40 | MG | INJECTION | QOW | |||||
| 109282654 | 10928265 | 2 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | 0 | 125 | MG | ||||||||||
| 109282654 | 10928265 | 3 | C | THIOPURINE METABOLITES-6TGN 286 6MMP 4380 | 2 | 0 | |||||||||||||
| 109282654 | 10928265 | 4 | C | SALAZOPYRIN | SULFASALAZINE | 1 | 0 | 2 | G | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109282654 | 10928265 | 1 | Crohn's disease |
| 109282654 | 10928265 | 2 | Crohn's disease |
| 109282654 | 10928265 | 3 | Product used for unknown indication |
| 109282654 | 10928265 | 4 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109282654 | 10928265 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109282654 | 10928265 | Colitis | |
| 109282654 | 10928265 | Crohn's disease | |
| 109282654 | 10928265 | Drug level below therapeutic | |
| 109282654 | 10928265 | Haematochezia | |
| 109282654 | 10928265 | Malaise | |
| 109282654 | 10928265 | Mucous stools |
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 |
|---|---|---|---|---|---|---|
| 109282654 | 10928265 | 1 | 2011 | 0 | ||
| 109282654 | 10928265 | 2 | 201302 | 0 | ||
| 109282654 | 10928265 | 3 | 201502 | 0 |