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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123330205 | 12333020 | 5 | F | 20141123 | 20160818 | 20160504 | 20160824 | EXP | CA-JNJFOC-20160402398 | JANSSEN | 56.43 | YR | A | M | Y | 81.10000 | KG | 20160824 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123330205 | 12333020 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FJM90015;FJM80011;FKM95012 +MORE | 0 | 900 | MG | LYOPHILIZED POWDER | ||||||
123330205 | 12333020 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FJM90015;FJM80011;FKM95012 +MORE | 0 | 900 | MG | LYOPHILIZED POWDER | ||||||
123330205 | 12333020 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FJM90015;FJM80011;FKM95012 +MORE | 0 | 900 | MG | LYOPHILIZED POWDER | ||||||
123330205 | 12333020 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FJM90015;FJM80011;FKM95012 +MORE | 0 | 900 | MG | LYOPHILIZED POWDER | ||||||
123330205 | 12333020 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FJM90015;FJM80011;FKM95012 +MORE | 0 | 900 | MG | LYOPHILIZED POWDER | ||||||
123330205 | 12333020 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FJM90015;FJM80011;FKM95012 +MORE | 103772 | 900 | MG | LYOPHILIZED POWDER |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
123330205 | 12333020 | 1 | Colitis ulcerative |
123330205 | 12333020 | 2 | Colitis ulcerative |
123330205 | 12333020 | 3 | Colitis ulcerative |
123330205 | 12333020 | 4 | Colitis ulcerative |
123330205 | 12333020 | 5 | Colitis ulcerative |
123330205 | 12333020 | 6 | Colitis ulcerative |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
123330205 | 12333020 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
123330205 | 12333020 | Asthenia | |
123330205 | 12333020 | Decreased appetite | |
123330205 | 12333020 | Dizziness | |
123330205 | 12333020 | Frequent bowel movements | |
123330205 | 12333020 | General physical health deterioration | |
123330205 | 12333020 | Haematochezia | |
123330205 | 12333020 | Off label use | |
123330205 | 12333020 | Product use issue | |
123330205 | 12333020 | Skin plaque | |
123330205 | 12333020 | Weight increased |
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 |
---|---|---|---|---|---|---|
123330205 | 12333020 | 1 | 20160622 | 0 | ||
123330205 | 12333020 | 2 | 20141204 | 0 | ||
123330205 | 12333020 | 3 | 20160527 | 0 | ||
123330205 | 12333020 | 4 | 20141123 | 0 | ||
123330205 | 12333020 | 5 | 20160721 | 0 | ||
123330205 | 12333020 | 6 | 20160818 | 0 |