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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121677876 | 12167787 | 6 | F | 2016 | 20160805 | 20160310 | 20160812 | EXP | CA-JNJFOC-20160306779 | JANSSEN | 17.17 | YR | T | F | Y | 55.00000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121677876 | 12167787 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FIM79012;GAM08012 | 0 | 600 | MG | LYOPHILIZED POWDER | |||||
| 121677876 | 12167787 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FIM79012;GAM08012 | 0 | 600 | MG | LYOPHILIZED POWDER | |||||
| 121677876 | 12167787 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FIM79012;GAM08012 | 0 | 600 | MG | LYOPHILIZED POWDER | |||||
| 121677876 | 12167787 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FIM79012;GAM08012 | 0 | 600 | MG | LYOPHILIZED POWDER | |||||
| 121677876 | 12167787 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FIM79012;GAM08012 | 103772 | 10 | MG/KG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121677876 | 12167787 | 1 | Colitis ulcerative |
| 121677876 | 12167787 | 2 | Colitis ulcerative |
| 121677876 | 12167787 | 3 | Colitis ulcerative |
| 121677876 | 12167787 | 4 | Colitis ulcerative |
| 121677876 | 12167787 | 5 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121677876 | 12167787 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121677876 | 12167787 | Clostridium difficile infection | |
| 121677876 | 12167787 | Colitis ulcerative | |
| 121677876 | 12167787 | Ear infection | |
| 121677876 | 12167787 | General physical health deterioration | |
| 121677876 | 12167787 | Lower respiratory tract infection | |
| 121677876 | 12167787 | Therapeutic response decreased |
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 |
|---|---|---|---|---|---|---|
| 121677876 | 12167787 | 1 | 20160624 | 0 | ||
| 121677876 | 12167787 | 2 | 20160429 | 0 | ||
| 121677876 | 12167787 | 3 | 20130311 | 0 | ||
| 121677876 | 12167787 | 4 | 20130101 | 0 | ||
| 121677876 | 12167787 | 5 | 2013 | 20160624 | 0 |