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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126050621 | 12605062 | 1 | I | 20160713 | 20160728 | 20160728 | EXP | CA-JNJFOC-20160714342 | JOHNSON AND JOHNSON | 0.00 | A | F | Y | 61.00000 | KG | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126050621 | 12605062 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FLM04014 | 103772 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 126050621 | 12605062 | 2 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | TABLET | ||||||||
| 126050621 | 12605062 | 3 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | 650 | MG | TABLET | ||||||
| 126050621 | 12605062 | 4 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | U | U | 999999 | CAPSULE | ||||||||
| 126050621 | 12605062 | 5 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | U | U | 5845 | 25 | MG | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126050621 | 12605062 | 1 | Crohn's disease |
| 126050621 | 12605062 | 3 | Premedication |
| 126050621 | 12605062 | 5 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126050621 | 12605062 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126050621 | 12605062 | Abortion spontaneous | |
| 126050621 | 12605062 | Exposure during pregnancy |
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 |
|---|---|---|---|---|---|---|
| 126050621 | 12605062 | 1 | 20140421 | 20160517 | 0 |