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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122152924 | 12215292 | 4 | F | 20130711 | 20160630 | 20160328 | 20160707 | EXP | CA-JNJFOC-20160222456 | JANSSEN | 34.68 | YR | A | M | Y | 84.90000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122152924 | 12215292 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 10 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 103772 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 122152924 | 12215292 | 11 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | TID | |||||||
| 122152924 | 12215292 | 12 | C | ASACOL | MESALAMINE | 1 | Oral | 500 (UNIT UNSPECIFIED) | 0 | 500 | MG | UNSPECIFIED | BID | ||||||
| 122152924 | 12215292 | 13 | C | RANITIDIN | RANITIDINE HYDROCHLORIDE | 1 | Oral | 0 | 150 | MG | UNSPECIFIED | BID | |||||||
| 122152924 | 12215292 | 14 | C | RANITIDIN | RANITIDINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | UNSPECIFIED | ||||||||
| 122152924 | 12215292 | 15 | C | RANITIDIN | RANITIDINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | UNSPECIFIED | BID | |||||||
| 122152924 | 12215292 | 16 | C | RANITIDIN | RANITIDINE HYDROCHLORIDE | 1 | Oral | 150 (UNIT UNSPECIFIED) | 0 | UNSPECIFIED | |||||||||
| 122152924 | 12215292 | 17 | C | PREDNISONE. | PREDNISONE | 1 | Oral | DOSE GRADUALLY DECREASED | 0 | 40 | MG | UNSPECIFIED | QD | ||||||
| 122152924 | 12215292 | 18 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 12.5 | MG | UNSPECIFIED | QD | |||||||
| 122152924 | 12215292 | 19 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 2.5 | MG | UNSPECIFIED | QD | |||||||
| 122152924 | 12215292 | 20 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 0 | 50 | MG | TABLET | QID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122152924 | 12215292 | 1 | Crohn's disease |
| 122152924 | 12215292 | 2 | Crohn's disease |
| 122152924 | 12215292 | 3 | Crohn's disease |
| 122152924 | 12215292 | 4 | Crohn's disease |
| 122152924 | 12215292 | 5 | Crohn's disease |
| 122152924 | 12215292 | 6 | Colitis ulcerative |
| 122152924 | 12215292 | 7 | Colitis ulcerative |
| 122152924 | 12215292 | 8 | Colitis ulcerative |
| 122152924 | 12215292 | 9 | Colitis ulcerative |
| 122152924 | 12215292 | 10 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122152924 | 12215292 | OT |
| 122152924 | 12215292 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122152924 | 12215292 | Abdominal pain | |
| 122152924 | 12215292 | Diarrhoea | |
| 122152924 | 12215292 | Frequent bowel movements | |
| 122152924 | 12215292 | General physical health deterioration | |
| 122152924 | 12215292 | Haematochezia | |
| 122152924 | 12215292 | Off label use | |
| 122152924 | 12215292 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 122152924 | 12215292 | 1 | 20130711 | 0 | ||
| 122152924 | 12215292 | 2 | 20160419 | 0 | ||
| 122152924 | 12215292 | 3 | 201310 | 0 | ||
| 122152924 | 12215292 | 4 | 20160602 | 0 | ||
| 122152924 | 12215292 | 5 | 20160630 | 0 | ||
| 122152924 | 12215292 | 6 | 20160419 | 0 | ||
| 122152924 | 12215292 | 7 | 20130711 | 0 | ||
| 122152924 | 12215292 | 8 | 20160630 | 0 | ||
| 122152924 | 12215292 | 9 | 20160602 | 0 | ||
| 122152924 | 12215292 | 10 | 201310 | 0 |