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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125498522 | 12549852 | 2 | F | 20160320 | 20160806 | 20160712 | 20160815 | EXP | CA-JNJFOC-20160320274 | JANSSEN | 43.96 | YR | A | M | Y | 72.00000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125498522 | 12549852 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 800 | MG | LYOPHILIZED POWDER | ||||||
| 125498522 | 12549852 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 800 | MG | LYOPHILIZED POWDER | ||||||
| 125498522 | 12549852 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 800 | MG | LYOPHILIZED POWDER | ||||||
| 125498522 | 12549852 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 103772 | 800 | MG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125498522 | 12549852 | 1 | Crohn's disease |
| 125498522 | 12549852 | 2 | Crohn's disease |
| 125498522 | 12549852 | 3 | Crohn's disease |
| 125498522 | 12549852 | 4 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125498522 | 12549852 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125498522 | 12549852 | Crohn's disease | |
| 125498522 | 12549852 | General physical health deterioration | |
| 125498522 | 12549852 | Pyrexia | |
| 125498522 | 12549852 | Vomiting | |
| 125498522 | 12549852 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125498522 | 12549852 | 1 | 20160516 | 0 | ||
| 125498522 | 12549852 | 2 | 20160321 | 0 | ||
| 125498522 | 12549852 | 3 | 20131216 | 0 | ||
| 125498522 | 12549852 | 4 | 20160707 | 0 |