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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123272903 | 12327290 | 3 | F | 201604 | 20160726 | 20160503 | 20160803 | EXP | CA-JNJFOC-20160427868 | JANSSEN | 38.42 | YR | A | F | Y | 95.00000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123272903 | 12327290 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 123272903 | 12327290 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 123272903 | 12327290 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 123272903 | 12327290 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 2ND INFUSION | N | GBM13012 | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
| 123272903 | 12327290 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | THIRD INFUSION, LOADING DOSE 3 | N | GBM13012 | 103772 | 500 | MG | LYOPHILIZED POWDER | |||||
| 123272903 | 12327290 | 6 | C | IMURAN | AZATHIOPRINE | 1 | Oral | 0 | 150 | MG | UNSPECIFIED | QD | |||||||
| 123272903 | 12327290 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123272903 | 12327290 | 1 | Colitis ulcerative |
| 123272903 | 12327290 | 2 | Colitis ulcerative |
| 123272903 | 12327290 | 3 | Colitis ulcerative |
| 123272903 | 12327290 | 4 | Colitis ulcerative |
| 123272903 | 12327290 | 5 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123272903 | 12327290 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123272903 | 12327290 | Frequent bowel movements | |
| 123272903 | 12327290 | General physical health deterioration | |
| 123272903 | 12327290 | Haematochezia | |
| 123272903 | 12327290 | Headache | |
| 123272903 | 12327290 | Myalgia |
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 |
|---|---|---|---|---|---|---|
| 123272903 | 12327290 | 1 | 20160715 | 0 | ||
| 123272903 | 12327290 | 2 | 20160726 | 0 | ||
| 123272903 | 12327290 | 3 | 20160416 | 0 | ||
| 123272903 | 12327290 | 4 | 20160428 | 0 | ||
| 123272903 | 12327290 | 5 | 20160526 | 0 |