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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126857051 | 12685705 | 1 | I | 20160819 | 20160819 | 20160825 | 20160825 | EXP | CA-JNJFOC-20160816144 | JANSSEN | 42.32 | YR | A | F | Y | 56.80000 | KG | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126857051 | 12685705 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | GAM08012 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 126857051 | 12685705 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | GAM08012 | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 126857051 | 12685705 | 3 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | 0 | 50 | MG | UNSPECIFIED | |||||||
| 126857051 | 12685705 | 4 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 2 TABS DAILY | 0 | 2 | DF | TABLET | QD | ||||||
| 126857051 | 12685705 | 5 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 2 TABS FROM MONDAY TO FRIDAY | 0 | 2 | DF | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126857051 | 12685705 | 1 | Colitis ulcerative |
| 126857051 | 12685705 | 2 | Colitis ulcerative |
| 126857051 | 12685705 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126857051 | 12685705 | HO |
| 126857051 | 12685705 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126857051 | 12685705 | Chest discomfort | |
| 126857051 | 12685705 | Flushing | |
| 126857051 | 12685705 | Hypoaesthesia | |
| 126857051 | 12685705 | Hypotension | |
| 126857051 | 12685705 | Infusion related reaction | |
| 126857051 | 12685705 | Off label use | |
| 126857051 | 12685705 | Product use issue | |
| 126857051 | 12685705 | Pruritus | |
| 126857051 | 12685705 | Throat tightness | |
| 126857051 | 12685705 | Tremor | |
| 126857051 | 12685705 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 126857051 | 12685705 | 2 | 20160819 | 0 | ||
| 126857051 | 12685705 | 3 | 20160819 | 0 |