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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125884331 | 12588433 | 1 | I | 20160607 | 20160609 | 20160725 | 20160725 | PER | US-JNJFOC-20160610853 | JANSSEN | 35.02 | YR | A | M | Y | 92.53000 | KG | 20160725 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125884331 | 12588433 | 1 | PS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | AS NEEDED | U | U | 999999 | 25 | MG | CAPSULE | |||||
| 125884331 | 12588433 | 2 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | UNSPECIFIED | ||||||||
| 125884331 | 12588433 | 3 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | UNSPECIFIED | ||||||||
| 125884331 | 12588433 | 4 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 450 | MG | INTRAVENOUS INFUSION | ||||||||
| 125884331 | 12588433 | 5 | C | CHANTIX | VARENICLINE TARTRATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884331 | 12588433 | 6 | C | ASACOL | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125884331 | 12588433 | 1 | Premedication |
| 125884331 | 12588433 | 3 | Premedication |
| 125884331 | 12588433 | 4 | Colitis ulcerative |
| 125884331 | 12588433 | 5 | Smoking cessation therapy |
| 125884331 | 12588433 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125884331 | 12588433 | Off label use | |
| 125884331 | 12588433 | 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 |
|---|---|---|---|---|---|---|
| 125884331 | 12588433 | 1 | 20160607 | 20160607 | 0 | |
| 125884331 | 12588433 | 3 | 20160607 | 20160607 | 0 | |
| 125884331 | 12588433 | 4 | 20160524 | 0 |