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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125251902 | 12525190 | 2 | F | 20160414 | 20160628 | 20160704 | 20160708 | EXP | CA-JNJFOC-20160513082 | JANSSEN | 62.49 | YR | A | F | Y | 62.20000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125251902 | 12525190 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | FJM 90014;GAM08012 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 125251902 | 12525190 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | FJM 90014;GAM08012 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 125251902 | 12525190 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | FJM 90014;GAM08012 | 103772 | 500 | MG | LYOPHILIZED POWDER | |||||
| 125251902 | 12525190 | 4 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | 0 | 650 | MG | LIQUID | ||||||||
| 125251902 | 12525190 | 5 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Unknown | 0 | 50 | MG | LIQUID | ||||||||
| 125251902 | 12525190 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125251902 | 12525190 | 1 | Colitis ulcerative |
| 125251902 | 12525190 | 2 | Colitis ulcerative |
| 125251902 | 12525190 | 3 | Colitis ulcerative |
| 125251902 | 12525190 | 4 | Premedication |
| 125251902 | 12525190 | 5 | Premedication |
| 125251902 | 12525190 | 6 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125251902 | 12525190 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125251902 | 12525190 | Frequent bowel movements | |
| 125251902 | 12525190 | General physical health deterioration | |
| 125251902 | 12525190 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 125251902 | 12525190 | 1 | 20160318 | 0 | ||
| 125251902 | 12525190 | 2 | 20160415 | 0 | ||
| 125251902 | 12525190 | 3 | 20160628 | 0 |