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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122784085 | 12278408 | 5 | F | 2016 | 20160630 | 20160418 | 20160706 | EXP | CA-JNJFOC-20160217102 | JANSSEN | 39.29 | YR | A | M | Y | 72.70000 | KG | 20160706 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122784085 | 12278408 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FIM79012;FIM76016;FLM04015 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 122784085 | 12278408 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FIM79012;FIM76016;FLM04015 | 0 | LYOPHILIZED POWDER | ||||||||
| 122784085 | 12278408 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FIM79012;FIM76016;FLM04015 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 122784085 | 12278408 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FIM79012;FIM76016;FLM04015 | 103772 | 800 | MG | LYOPHILIZED POWDER | ||||||
| 122784085 | 12278408 | 5 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 0 | 175 | MG | UNSPECIFIED | ||||||||
| 122784085 | 12278408 | 6 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 0 | 150 | MG | UNSPECIFIED | ||||||||
| 122784085 | 12278408 | 7 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 0 | 175 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122784085 | 12278408 | 1 | Crohn's disease |
| 122784085 | 12278408 | 2 | Crohn's disease |
| 122784085 | 12278408 | 3 | Crohn's disease |
| 122784085 | 12278408 | 4 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122784085 | 12278408 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122784085 | 12278408 | Abdominal pain | |
| 122784085 | 12278408 | Haematochezia | |
| 122784085 | 12278408 | Off label use | |
| 122784085 | 12278408 | Product use issue | |
| 122784085 | 12278408 | Rectal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 122784085 | 12278408 | 2 | 20141015 | 0 | ||
| 122784085 | 12278408 | 3 | 20100406 | 0 | ||
| 122784085 | 12278408 | 4 | 20160527 | 0 |