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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127246471 | 12724647 | 1 | I | 20160722 | 20160729 | 20160908 | 20160908 | PER | US-JNJFOC-20160800874 | JANSSEN | 43.66 | YR | A | M | Y | 93.44000 | KG | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127246471 | 12724647 | 1 | PS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | U | 19835 | UNSPECIFIED | ||||||||
| 127246471 | 12724647 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | AT NIGHT | U | U | 19835 | UNSPECIFIED | |||||||
| 127246471 | 12724647 | 3 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | AT NIGHT | U | U | 999999 | 3 | DF | UNSPECIFIED | |||||
| 127246471 | 12724647 | 4 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | SINCE BEFORE 2007 | 0 | 5 | MG/KG | LYOPHILIZED POWDER | |||||||
| 127246471 | 12724647 | 5 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||||
| 127246471 | 12724647 | 6 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||||
| 127246471 | 12724647 | 7 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | SINCE BEFORE 2007 | 0 | 5 | MG/KG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127246471 | 12724647 | 2 | Urticaria |
| 127246471 | 12724647 | 3 | Urticaria |
| 127246471 | 12724647 | 4 | Enterocolitis |
| 127246471 | 12724647 | 5 | Enterocolitis |
| 127246471 | 12724647 | 6 | Crohn's disease |
| 127246471 | 12724647 | 7 | Crohn's disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127246471 | 12724647 | Drug ineffective for unapproved indication | |
| 127246471 | 12724647 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 127246471 | 12724647 | 2 | 20160722 | 0 | ||
| 127246471 | 12724647 | 3 | 20160722 | 0 | ||
| 127246471 | 12724647 | 5 | 20160722 | 0 | ||
| 127246471 | 12724647 | 6 | 20160722 | 0 |