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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110099754 | 11009975 | 4 | F | 201405 | 20160824 | 20150410 | 20160831 | EXP | AU-ABBVIE-15K-008-1372871-00 | ABBVIE | 64.66 | YR | M | Y | 125.00000 | KG | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110099754 | 11009975 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 40 | MG | INJECTION | QOW | |||||
| 110099754 | 11009975 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | DOSE INCREASED | Y | UNKNOWN | 125057 | 40 | MG | INJECTION | /wk | ||||
| 110099754 | 11009975 | 3 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 110099754 | 11009975 | 4 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | UNKNOWN | 0 | 610 | MG | |||||||
| 110099754 | 11009975 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 5MG/7.5MG | 0 | 25 | MG | BIW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110099754 | 11009975 | 1 | Crohn's disease |
| 110099754 | 11009975 | 3 | Crohn's disease |
| 110099754 | 11009975 | 4 | Intestinal fistula |
| 110099754 | 11009975 | 5 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110099754 | 11009975 | OT |
| 110099754 | 11009975 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110099754 | 11009975 | Anal fistula | |
| 110099754 | 11009975 | Drug level decreased | |
| 110099754 | 11009975 | Fistula discharge | |
| 110099754 | 11009975 | Infusion related reaction | |
| 110099754 | 11009975 | Pain | |
| 110099754 | 11009975 | Proctalgia | |
| 110099754 | 11009975 | Sepsis | |
| 110099754 | 11009975 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 110099754 | 11009975 | 1 | 201102 | 20140521 | 0 | |
| 110099754 | 11009975 | 2 | 201503 | 0 | ||
| 110099754 | 11009975 | 4 | 20141218 | 20150129 | 0 | |
| 110099754 | 11009975 | 5 | 20141112 | 0 |