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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124829464 | 12482946 | 4 | F | 20160601 | 20160908 | 20160620 | 20160913 | EXP | CA-JNJFOC-20160614082 | JANSSEN | 33.10 | YR | A | M | Y | 110.00000 | KG | 20160913 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124829464 | 12482946 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011;GAM08013;GBM13012 +MORE | 0 | 1000 | MG | LYOPHILIZED POWDER | ||||||
| 124829464 | 12482946 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011;GAM08013;GBM13012 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 124829464 | 12482946 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011;GAM08013;GBM13012 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 124829464 | 12482946 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011;GAM08013;GBM13012 +MORE | 0 | 1000 | MG | LYOPHILIZED POWDER | ||||||
| 124829464 | 12482946 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011;GAM08013;GBM13012 +MORE | 0 | 1000 | MG | LYOPHILIZED POWDER | ||||||
| 124829464 | 12482946 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011;GAM08013;GBM13012 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 124829464 | 12482946 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011;GAM08013;GBM13012 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 124829464 | 12482946 | 8 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011;GAM08013;GBM13012 +MORE | 103772 | 1000 | MG | LYOPHILIZED POWDER | ||||||
| 124829464 | 12482946 | 9 | C | MEZAVANT | MESALAMINE | 1 | Unknown | PRN (WHEN NEEDED) | 0 | TABLET | |||||||||
| 124829464 | 12482946 | 10 | C | HYDROMORPH CONTIN | HYDROMORPHONE | 1 | Unknown | 0 | 3 | MG | UNSPECIFIED | BID | |||||||
| 124829464 | 12482946 | 11 | C | HYDROMORPH CONTIN | HYDROMORPHONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124829464 | 12482946 | 12 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Unknown | AS NECESSARY | 0 | 2 | MG | UNSPECIFIED | |||||||
| 124829464 | 12482946 | 13 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 60 UNITS UNSPECIFIED | 0 | 60 | MG | UNSPECIFIED | QD | ||||||
| 124829464 | 12482946 | 14 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124829464 | 12482946 | 15 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124829464 | 12482946 | 16 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | 150 (UNIT UNSPECIFIED) HS (HOUR OF SLEEP) | 0 | UNSPECIFIED | |||||||||
| 124829464 | 12482946 | 17 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | DECREASING DOSE | 0 | UNSPECIFIED | |||||||||
| 124829464 | 12482946 | 18 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124829464 | 12482946 | 19 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | Unknown | 30 UNITS UNSPECIFIED | 0 | 30 | MG | UNSPECIFIED | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124829464 | 12482946 | 1 | Crohn's disease |
| 124829464 | 12482946 | 2 | Crohn's disease |
| 124829464 | 12482946 | 3 | Crohn's disease |
| 124829464 | 12482946 | 4 | Crohn's disease |
| 124829464 | 12482946 | 5 | Colitis ulcerative |
| 124829464 | 12482946 | 6 | Colitis ulcerative |
| 124829464 | 12482946 | 7 | Colitis ulcerative |
| 124829464 | 12482946 | 8 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124829464 | 12482946 | OT |
| 124829464 | 12482946 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124829464 | 12482946 | Crohn's disease | |
| 124829464 | 12482946 | General physical health deterioration | |
| 124829464 | 12482946 | Intervertebral disc protrusion | |
| 124829464 | 12482946 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 124829464 | 12482946 | 2 | 20150426 | 0 | ||
| 124829464 | 12482946 | 3 | 20150826 | 0 | ||
| 124829464 | 12482946 | 4 | 20160908 | 0 | ||
| 124829464 | 12482946 | 6 | 20150426 | 0 | ||
| 124829464 | 12482946 | 7 | 20150826 | 0 | ||
| 124829464 | 12482946 | 8 | 20160908 | 0 |