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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124290775 | 12429077 | 5 | F | 20160827 | 20160831 | 20160602 | 20160908 | EXP | CA-JNJFOC-20160529266 | JANSSEN | 31.58 | YR | A | M | Y | 76.00000 | KG | 20160908 | CN | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124290775 | 12429077 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
124290775 | 12429077 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
124290775 | 12429077 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
124290775 | 12429077 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
124290775 | 12429077 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 103772 | 400 | MG | LYOPHILIZED POWDER | ||||||
124290775 | 12429077 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
124290775 | 12429077 | 1 | Colitis ulcerative |
124290775 | 12429077 | 2 | Colitis ulcerative |
124290775 | 12429077 | 3 | Colitis ulcerative |
124290775 | 12429077 | 4 | Colitis ulcerative |
124290775 | 12429077 | 5 | Colitis ulcerative |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
124290775 | 12429077 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
124290775 | 12429077 | Colitis ulcerative | |
124290775 | 12429077 | Drug ineffective | |
124290775 | 12429077 | General physical health deterioration | |
124290775 | 12429077 | Off label use | |
124290775 | 12429077 | Product use issue |
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 |
---|---|---|---|---|---|---|
124290775 | 12429077 | 1 | 20160528 | 0 | ||
124290775 | 12429077 | 2 | 20151221 | 0 | ||
124290775 | 12429077 | 4 | 20160831 | 0 | ||
124290775 | 12429077 | 5 | 20160723 | 0 |