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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126448631 | 12644863 | 1 | I | 20160104 | 20160801 | 20160811 | 20160811 | EXP | FR-JNJFOC-20160803475 | JANSSEN | 47.14 | YR | A | F | Y | 0.00000 | 20160811 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126448631 | 12644863 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | Y | 0 | LYOPHILIZED POWDER | ||||||||
| 126448631 | 12644863 | 2 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | Y | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 126448631 | 12644863 | 3 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | Y | 103772 | 5 | MG/KG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126448631 | 12644863 | 1 | Crohn's disease |
| 126448631 | 12644863 | 2 | Crohn's disease |
| 126448631 | 12644863 | 3 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126448631 | 12644863 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126448631 | 12644863 | Anaphylactoid reaction | Anaphylactoid reaction |
| 126448631 | 12644863 | Dyspnoea | |
| 126448631 | 12644863 | Hot flush | |
| 126448631 | 12644863 | Hyperthermia | |
| 126448631 | 12644863 | Infusion related reaction | Infusion related reaction |
| 126448631 | 12644863 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126448631 | 12644863 | 1 | 20160104 | 0 | ||
| 126448631 | 12644863 | 2 | 20160201 | 20160201 | 0 | |
| 126448631 | 12644863 | 3 | 20151217 | 0 |