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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89134484 | 8913448 | 4 | F | 20100830 | 20160728 | 20121119 | 20160804 | EXP | CA-JNJFOC-20121105161 | JANSSEN | 32.26 | YR | A | M | Y | 112.00000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89134484 | 8913448 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 800 | MG | LYOPHILIZED POWDER | |||||||
| 89134484 | 8913448 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 89134484 | 8913448 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 500 | MG | LYOPHILIZED POWDER | |||||||
| 89134484 | 8913448 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | 500 | MG | LYOPHILIZED POWDER | |||||||
| 89134484 | 8913448 | 5 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 4 TABLETS | 0 | TABLETS | |||||||||
| 89134484 | 8913448 | 6 | C | ATIVAN | LORAZEPAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 89134484 | 8913448 | 7 | C | CHOLESTYRAMINE. | CHOLESTYRAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 89134484 | 8913448 | 8 | C | OXAZEPAM. | OXAZEPAM | 1 | Unknown | HOUR OF SLEEP | 0 | UNSPECIFIED | |||||||||
| 89134484 | 8913448 | 9 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Unknown | PRN | 0 | UNSPECIFIED | |||||||||
| 89134484 | 8913448 | 10 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 89134484 | 8913448 | 11 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 89134484 | 8913448 | 12 | C | CLONIDINE. | CLONIDINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 89134484 | 8913448 | 1 | Crohn's disease |
| 89134484 | 8913448 | 2 | Crohn's disease |
| 89134484 | 8913448 | 3 | Crohn's disease |
| 89134484 | 8913448 | 4 | Crohn's disease |
| 89134484 | 8913448 | 8 | Sleep disorder therapy |
| 89134484 | 8913448 | 10 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 89134484 | 8913448 | HO |
| 89134484 | 8913448 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 89134484 | 8913448 | Abscess intestinal | |
| 89134484 | 8913448 | Cholecystectomy | |
| 89134484 | 8913448 | Fistula | |
| 89134484 | 8913448 | Hernia | |
| 89134484 | 8913448 | Inappropriate schedule of drug administration | |
| 89134484 | 8913448 | Nausea | |
| 89134484 | 8913448 | Off label use | |
| 89134484 | 8913448 | Pain | |
| 89134484 | 8913448 | Postoperative abscess | |
| 89134484 | 8913448 | Product use issue | |
| 89134484 | 8913448 | Pyrexia | |
| 89134484 | 8913448 | Scar |
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 |
|---|---|---|---|---|---|---|
| 89134484 | 8913448 | 2 | 20160415 | 0 | ||
| 89134484 | 8913448 | 3 | 20100830 | 0 | ||
| 89134484 | 8913448 | 4 | 20120821 | 0 |