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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124044355 | 12404435 | 5 | F | 20151212 | 20160726 | 20160525 | 20160728 | EXP | CA-JNJFOC-20160419040 | JANSSEN | 17.62 | YR | T | M | Y | 54.43000 | KG | 20160728 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124044355 | 12404435 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | ONCE EVERY 4-6 WEEKS | N | UNKNOWN | 0 | 550 | MG | LYOPHILIZED POWDER | |||||
124044355 | 12404435 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 550 | MG | LYOPHILIZED POWDER | ||||||
124044355 | 12404435 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 550 | MG | LYOPHILIZED POWDER | ||||||
124044355 | 12404435 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 103772 | 10 | MG/KG | LYOPHILIZED POWDER | ||||||
124044355 | 12404435 | 5 | C | IMURAN | AZATHIOPRINE | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | QD | |||||||
124044355 | 12404435 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | QD | |||||||
124044355 | 12404435 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Oral | TAPERING DOSE | 0 | 8 | MG | UNSPECIFIED | QD | ||||||
124044355 | 12404435 | 8 | C | PENTASA | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
124044355 | 12404435 | 1 | Colitis ulcerative |
124044355 | 12404435 | 2 | Colitis ulcerative |
124044355 | 12404435 | 3 | Colitis ulcerative |
124044355 | 12404435 | 4 | Colitis ulcerative |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
124044355 | 12404435 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
124044355 | 12404435 | Colitis ulcerative | |
124044355 | 12404435 | Drug ineffective | |
124044355 | 12404435 | Fistula | |
124044355 | 12404435 | General physical health deterioration | |
124044355 | 12404435 | Off label use | |
124044355 | 12404435 | 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 |
---|---|---|---|---|---|---|
124044355 | 12404435 | 1 | 20151212 | 0 | ||
124044355 | 12404435 | 2 | 20160419 | 0 | ||
124044355 | 12404435 | 3 | 20160519 | 0 | ||
124044355 | 12404435 | 4 | 20160719 | 0 |