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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117752585 | 11775258 | 5 | F | 20160923 | 20151124 | 20160927 | EXP | US-JNJFOC-20151121179 | JANSSEN | 0.00 | A | F | Y | 53.52000 | KG | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117752585 | 11775258 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FGI55016PI;15B133P1 +MORE | 0 | 5 | MG/KG | LYOPHILIZED POWDER | |||||
| 117752585 | 11775258 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FGI55016PI;15B133P1 +MORE | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 117752585 | 11775258 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FGI55016PI;15B133P1 +MORE | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 117752585 | 11775258 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FGI55016PI;15B133P1 +MORE | 103772 | 5 | MG/KG | LYOPHILIZED POWDER | |||||
| 117752585 | 11775258 | 5 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | D | 0 | 500 | MG | UNSPECIFIED | |||||||
| 117752585 | 11775258 | 6 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | D | 0 | 25 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117752585 | 11775258 | 1 | Crohn's disease |
| 117752585 | 11775258 | 2 | Crohn's disease |
| 117752585 | 11775258 | 3 | Colitis ulcerative |
| 117752585 | 11775258 | 4 | Colitis ulcerative |
| 117752585 | 11775258 | 5 | Premedication |
| 117752585 | 11775258 | 6 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117752585 | 11775258 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117752585 | 11775258 | Drug ineffective | |
| 117752585 | 11775258 | Drug level below therapeutic | |
| 117752585 | 11775258 | Eye inflammation | |
| 117752585 | 11775258 | Eyelid ptosis | |
| 117752585 | 11775258 | Infusion related reaction | |
| 117752585 | 11775258 | Periorbital oedema | |
| 117752585 | 11775258 | Pouchitis | |
| 117752585 | 11775258 | Surgery |
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 |
|---|---|---|---|---|---|---|
| 117752585 | 11775258 | 2 | 20150603 | 20151216 | 0 | |
| 117752585 | 11775258 | 3 | 20150603 | 20151216 | 0 |