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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100065987 | 10006598 | 7 | F | 2008 | 20160922 | 20140313 | 20160929 | EXP | CA-JNJFOC-20140114894 | JANSSEN | 45.00 | YR | A | F | Y | 69.50000 | KG | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100065987 | 10006598 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | DGM1901 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 100065987 | 10006598 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | FOR 52 WEEKS | N | DGM1901 | 103772 | 400 | MG | LYOPHILIZED POWDER | |||||
| 100065987 | 10006598 | 3 | C | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | D | 0 | 100 | MG | UNSPECIFIED | |||||||
| 100065987 | 10006598 | 4 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | D | 0 | 650 | MG | UNSPECIFIED | |||||||
| 100065987 | 10006598 | 5 | C | AERIUS | DESLORATADINE | 1 | Oral | D | 0 | 10 | MG | UNSPECIFIED | |||||||
| 100065987 | 10006598 | 6 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | D | 0 | INJECTION | |||||||||
| 100065987 | 10006598 | 7 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | D | 0 | 100 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100065987 | 10006598 | 1 | Crohn's disease |
| 100065987 | 10006598 | 2 | Crohn's disease |
| 100065987 | 10006598 | 3 | Premedication |
| 100065987 | 10006598 | 4 | Premedication |
| 100065987 | 10006598 | 5 | Premedication |
| 100065987 | 10006598 | 7 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100065987 | 10006598 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100065987 | 10006598 | Cervical cyst | |
| 100065987 | 10006598 | Cholelithiasis | |
| 100065987 | 10006598 | Off label use | |
| 100065987 | 10006598 | Ovarian cyst | |
| 100065987 | 10006598 | Product use issue | |
| 100065987 | 10006598 | Root canal infection | |
| 100065987 | 10006598 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 100065987 | 10006598 | 1 | 20080918 | 0 | ||
| 100065987 | 10006598 | 2 | 2008 | 0 |