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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123647024 | 12364702 | 4 | F | 201511 | 20160719 | 20160513 | 20160726 | EXP | CA-JNJFOC-20160506927 | JANSSEN | 45.53 | YR | A | M | Y | 70.20000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123647024 | 12364702 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FIM79012;FKM95012 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 123647024 | 12364702 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FIM79012;FKM95012 | 103772 | 400 | MG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123647024 | 12364702 | 1 | Crohn's disease |
| 123647024 | 12364702 | 2 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123647024 | 12364702 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123647024 | 12364702 | Abdominal pain | |
| 123647024 | 12364702 | Diarrhoea | |
| 123647024 | 12364702 | Drug effect decreased | |
| 123647024 | 12364702 | Fistula repair | |
| 123647024 | 12364702 | Frequent bowel movements | |
| 123647024 | 12364702 | General physical health deterioration | |
| 123647024 | 12364702 | Intestinal resection | |
| 123647024 | 12364702 | Nausea | |
| 123647024 | 12364702 | Nephrolithiasis |
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 |
|---|---|---|---|---|---|---|
| 123647024 | 12364702 | 1 | 20120901 | 0 | ||
| 123647024 | 12364702 | 2 | 20120924 | 0 |