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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120055692 | 12005569 | 2 | F | 200903 | 20160715 | 20160204 | 20160721 | EXP | CA-JNJFOC-20160200328 | JANSSEN | 48.20 | YR | A | M | Y | 91.80000 | KG | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120055692 | 12005569 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FGM59013;FIM04016 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 120055692 | 12005569 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FGM59013;FIM04016 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 120055692 | 12005569 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | THERAPY DURATION 1 HOUR | N | FGM59013;FIM04016 | 103772 | 400 | MG | LYOPHILIZED POWDER | |||||
| 120055692 | 12005569 | 4 | SS | IMURAN | AZATHIOPRINE | 1 | Unknown | Y | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120055692 | 12005569 | 1 | Colitis ulcerative |
| 120055692 | 12005569 | 2 | Colitis ulcerative |
| 120055692 | 12005569 | 3 | Colitis ulcerative |
| 120055692 | 12005569 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120055692 | 12005569 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120055692 | 12005569 | Basal cell carcinoma | |
| 120055692 | 12005569 | Off label use | |
| 120055692 | 12005569 | Product use issue | |
| 120055692 | 12005569 | Squamous cell carcinoma |
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 |
|---|---|---|---|---|---|---|
| 120055692 | 12005569 | 1 | 20151217 | 0 | ||
| 120055692 | 12005569 | 2 | 20160603 | 0 | ||
| 120055692 | 12005569 | 3 | 200903 | 0 |