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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126850982 | 12685098 | 2 | F | 201009 | 20160823 | 20160825 | 20160829 | EXP | CA-JNJFOC-20160525525 | JANSSEN | 24.72 | YR | A | F | Y | 89.00000 | KG | 20160829 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126850982 | 12685098 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 126850982 | 12685098 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 103772 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 126850982 | 12685098 | 3 | SS | IMURAN | AZATHIOPRINE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 126850982 | 12685098 | 4 | C | LYRICA | PREGABALIN | 1 | Unknown | 0 | 150 | MG | UNSPECIFIED | ||||||||
| 126850982 | 12685098 | 5 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | 0 | 200 | MG | UNSPECIFIED | QD | |||||||
| 126850982 | 12685098 | 6 | C | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 200 | MG | SOLUTION FOR INJECTION | ||||||||
| 126850982 | 12685098 | 7 | C | MORPHINE | MORPHINE | 1 | Oral | 0 | 400 | MG | UNSPECIFIED | QOD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126850982 | 12685098 | 1 | Crohn's disease |
| 126850982 | 12685098 | 2 | Crohn's disease |
| 126850982 | 12685098 | 3 | Product used for unknown indication |
| 126850982 | 12685098 | 4 | Back pain |
| 126850982 | 12685098 | 5 | Back pain |
| 126850982 | 12685098 | 7 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126850982 | 12685098 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126850982 | 12685098 | Abdominal pain | |
| 126850982 | 12685098 | Diarrhoea | |
| 126850982 | 12685098 | Intervertebral disc protrusion | |
| 126850982 | 12685098 | Meningitis | |
| 126850982 | 12685098 | Off label use | |
| 126850982 | 12685098 | Pancreatitis | |
| 126850982 | 12685098 | Product use issue | |
| 126850982 | 12685098 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126850982 | 12685098 | 1 | 20141015 | 0 | ||
| 126850982 | 12685098 | 2 | 201009 | 0 | ||
| 126850982 | 12685098 | 6 | 20141015 | 0 |