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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123555643 | 12355564 | 3 | F | 2014 | 20160727 | 20160511 | 20160801 | EXP | CA-JNJFOC-20160210831 | JANSSEN | 18.51 | YR | T | M | Y | 57.30000 | KG | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123555643 | 12355564 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67011;FKM95012;FJM90014 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 123555643 | 12355564 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67011;FKM95012;FJM90014 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 123555643 | 12355564 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67011;FKM95012;FJM90014 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 123555643 | 12355564 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67011;FKM95012;FJM90014 | 103772 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 123555643 | 12355564 | 5 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123555643 | 12355564 | 6 | C | ASACOL | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123555643 | 12355564 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123555643 | 12355564 | 8 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123555643 | 12355564 | 9 | C | 5-ASA | MESALAMINE | 1 | Unknown | 0 | 600 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123555643 | 12355564 | 1 | Colitis ulcerative |
| 123555643 | 12355564 | 2 | Colitis ulcerative |
| 123555643 | 12355564 | 3 | Colitis ulcerative |
| 123555643 | 12355564 | 4 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123555643 | 12355564 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123555643 | 12355564 | Frequent bowel movements | |
| 123555643 | 12355564 | General physical health deterioration | |
| 123555643 | 12355564 | Haematochezia | |
| 123555643 | 12355564 | Off label use | |
| 123555643 | 12355564 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 123555643 | 12355564 | 1 | 20160503 | 0 | ||
| 123555643 | 12355564 | 2 | 20151120 | 0 | ||
| 123555643 | 12355564 | 3 | 20160209 | 0 | ||
| 123555643 | 12355564 | 4 | 2014 | 0 |