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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123063824 | 12306382 | 4 | F | 20150920 | 20160711 | 20160426 | 20160713 | EXP | CA-JNJFOC-20160310503 | JANSSEN | 52.70 | YR | A | M | Y | 72.60000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123063824 | 12306382 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95011;FLM04016 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 123063824 | 12306382 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95011;FLM04016 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 123063824 | 12306382 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95011;FLM04016 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 123063824 | 12306382 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95011;FLM04016 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 123063824 | 12306382 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95011;FLM04016 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 123063824 | 12306382 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95011;FLM04016 | 103772 | 400 | MG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123063824 | 12306382 | 1 | Colitis |
| 123063824 | 12306382 | 2 | Colitis |
| 123063824 | 12306382 | 3 | Colitis |
| 123063824 | 12306382 | 4 | Crohn's disease |
| 123063824 | 12306382 | 5 | Crohn's disease |
| 123063824 | 12306382 | 6 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123063824 | 12306382 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123063824 | 12306382 | Abdominal pain | |
| 123063824 | 12306382 | Arthritis | |
| 123063824 | 12306382 | Contusion | |
| 123063824 | 12306382 | Crohn's disease | |
| 123063824 | 12306382 | Drug effect decreased | |
| 123063824 | 12306382 | Fatigue | |
| 123063824 | 12306382 | Frequent bowel movements | |
| 123063824 | 12306382 | General physical health deterioration | |
| 123063824 | 12306382 | Haematochezia | |
| 123063824 | 12306382 | Mucous stools | |
| 123063824 | 12306382 | Off label use | |
| 123063824 | 12306382 | Product use issue | |
| 123063824 | 12306382 | Systemic lupus erythematosus |
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 |
|---|---|---|---|---|---|---|
| 123063824 | 12306382 | 1 | 20151020 | 0 | ||
| 123063824 | 12306382 | 2 | 20150920 | 0 | ||
| 123063824 | 12306382 | 3 | 20160308 | 20160628 | 0 | |
| 123063824 | 12306382 | 4 | 20160308 | 20160628 | 0 | |
| 123063824 | 12306382 | 5 | 20150920 | 0 | ||
| 123063824 | 12306382 | 6 | 20151020 | 0 |