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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127588692 | 12758869 | 2 | F | 201608 | 20160916 | 20160919 | 20160921 | EXP | CA-JNJFOC-20160910849 | JANSSEN | 16.59 | YR | T | F | Y | 50.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127588692 | 12758869 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 127588692 | 12758869 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 127588692 | 12758869 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012 | 103772 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 127588692 | 12758869 | 4 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 127588692 | 12758869 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | D | 0 | 12.5 | MG | UNSPECIFIED | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127588692 | 12758869 | 1 | Colitis ulcerative |
| 127588692 | 12758869 | 2 | Colitis ulcerative |
| 127588692 | 12758869 | 3 | Colitis ulcerative |
| 127588692 | 12758869 | 4 | Product used for unknown indication |
| 127588692 | 12758869 | 5 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127588692 | 12758869 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127588692 | 12758869 | Abdominal pain | |
| 127588692 | 12758869 | Drug ineffective | |
| 127588692 | 12758869 | Frequent bowel movements | |
| 127588692 | 12758869 | Gastrointestinal disorder | |
| 127588692 | 12758869 | General physical health deterioration | |
| 127588692 | 12758869 | Haematochezia | |
| 127588692 | 12758869 | Mucous stools |
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 |
|---|---|---|---|---|---|---|
| 127588692 | 12758869 | 1 | 20151117 | 0 | ||
| 127588692 | 12758869 | 2 | 20160910 | 0 | ||
| 127588692 | 12758869 | 3 | 201508 | 0 | ||
| 127588692 | 12758869 | 4 | 20160906 | 2016 | 0 |