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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125288884 | 12528888 | 4 | F | 20150322 | 20160722 | 20160705 | 20160728 | EXP | US-JNJFOC-20160627695 | JANSSEN | 18.85 | YR | T | F | Y | 46.90000 | KG | 20160728 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125288884 | 12528888 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | LYOPHILIZED POWDER | |||||||||
| 125288884 | 12528888 | 2 | C | SIMPONI | GOLIMUMAB | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125288884 | 12528888 | 3 | C | HUMIRA | ADALIMUMAB | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125288884 | 12528888 | 4 | C | 5-ASA | MESALAMINE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 125288884 | 12528888 | 5 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125288884 | 12528888 | 6 | C | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125288884 | 12528888 | 7 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125288884 | 12528888 | 8 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125288884 | 12528888 | 9 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125288884 | 12528888 | 1 | Inflammatory bowel disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125288884 | 12528888 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125288884 | 12528888 | Clostridium difficile infection | |
| 125288884 | 12528888 | Colitis ulcerative |
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 |
|---|---|---|---|---|---|---|
| 125288884 | 12528888 | 1 | 20110425 | 20120911 | 0 | |
| 125288884 | 12528888 | 2 | 20150112 | 0 | ||
| 125288884 | 12528888 | 3 | 20130327 | 20141210 | 0 |