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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125888831 | 12588883 | 1 | I | 20160622 | 20160725 | 20160725 | PER | US-JNJFOC-20160624242 | JANSSEN | 0.00 | A | M | Y | 117.03000 | KG | 20160725 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125888831 | 12588883 | 1 | PS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 125888831 | 12588883 | 2 | SS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | ONCE | U | U | 19872 | 650 | MG | UNSPECIFIED | |||||
| 125888831 | 12588883 | 3 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | ONCE | U | U | 999999 | 50 | MG | UNSPECIFIED | |||||
| 125888831 | 12588883 | 4 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 15JD03141 | 0 | 250 | ML | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125888831 | 12588883 | 2 | Premedication |
| 125888831 | 12588883 | 3 | Premedication |
| 125888831 | 12588883 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125888831 | 12588883 | Off label use | |
| 125888831 | 12588883 | 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 |
|---|---|---|---|---|---|---|
| 125888831 | 12588883 | 2 | 20160324 | 0 | ||
| 125888831 | 12588883 | 3 | 20160324 | 0 |