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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126973583 | 12697358 | 3 | F | 2016 | 20160921 | 20160830 | 20160928 | EXP | US-JNJFOC-20160808693 | JOHNSON AND JOHNSON | 33.64 | YR | A | F | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126973583 | 12697358 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 126973583 | 12697358 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 6TH INFUSION | Y | U | 103772 | 5 | MG/KG | LYOPHILIZED POWDER | |||||
| 126973583 | 12697358 | 3 | SS | TYLENOL | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | UNSPECIFIED | ||||||||
| 126973583 | 12697358 | 4 | SS | TYLENOL | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | 650 | MG | UNSPECIFIED | ||||||
| 126973583 | 12697358 | 5 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | U | U | 999999 | 25 | MG | UNSPECIFIED | ||||||
| 126973583 | 12697358 | 6 | SS | TRAMADOL. | TRAMADOL | 1 | Unknown | U | U | 20281 | UNSPECIFIED | ||||||||
| 126973583 | 12697358 | 7 | C | LIALDA | MESALAMINE | 1 | Unknown | D | 0 | 4.8 | G | UNSPECIFIED | |||||||
| 126973583 | 12697358 | 8 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 126973583 | 12697358 | 9 | C | BENTYL | DICYCLOMINE HYDROCHLORIDE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 126973583 | 12697358 | 10 | C | MAXALT | RIZATRIPTAN BENZOATE | 1 | Unknown | D | 0 | 10 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126973583 | 12697358 | 1 | Colitis ulcerative |
| 126973583 | 12697358 | 2 | Colitis ulcerative |
| 126973583 | 12697358 | 4 | Premedication |
| 126973583 | 12697358 | 5 | Premedication |
| 126973583 | 12697358 | 6 | Product used for unknown indication |
| 126973583 | 12697358 | 7 | Crohn's disease |
| 126973583 | 12697358 | 10 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126973583 | 12697358 | OT |
| 126973583 | 12697358 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126973583 | 12697358 | Chest pain | |
| 126973583 | 12697358 | Drug hypersensitivity | |
| 126973583 | 12697358 | Exposure during pregnancy | |
| 126973583 | 12697358 | Flushing | |
| 126973583 | 12697358 | Hypoaesthesia | |
| 126973583 | 12697358 | Infusion related reaction | |
| 126973583 | 12697358 | Laryngeal oedema | |
| 126973583 | 12697358 | Lip swelling | |
| 126973583 | 12697358 | Rash |
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 |
|---|---|---|---|---|---|---|
| 126973583 | 12697358 | 1 | 20160301 | 20160805 | 0 | |
| 126973583 | 12697358 | 2 | 20160805 | 0 | ||
| 126973583 | 12697358 | 4 | 20160805 | 0 | ||
| 126973583 | 12697358 | 5 | 20160805 | 0 | ||
| 126973583 | 12697358 | 7 | 2015 | 0 | ||
| 126973583 | 12697358 | 10 | 20120307 | 0 |