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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121385002 | 12138500 | 2 | F | 20160913 | 20160302 | 20160919 | EXP | BR-JNJFOC-20160221046 | JANSSEN | 0.00 | A | F | Y | 47.00000 | KG | 20160919 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121385002 | 12138500 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 121385002 | 12138500 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 121385002 | 12138500 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 121385002 | 12138500 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 121385002 | 12138500 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 121385002 | 12138500 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 121385002 | 12138500 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 121385002 | 12138500 | 8 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 103772 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 121385002 | 12138500 | 9 | C | MESALAZINE | MESALAMINE | 1 | Unknown | D | 0 | 500 | MG | UNSPECIFIED | |||||||
| 121385002 | 12138500 | 10 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | D | 0 | 50 | MG | UNSPECIFIED | |||||||
| 121385002 | 12138500 | 11 | C | PENTASA | MESALAMINE | 1 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121385002 | 12138500 | 1 | Colitis |
| 121385002 | 12138500 | 2 | Colitis |
| 121385002 | 12138500 | 3 | Colitis |
| 121385002 | 12138500 | 4 | Colitis |
| 121385002 | 12138500 | 5 | Crohn's disease |
| 121385002 | 12138500 | 6 | Crohn's disease |
| 121385002 | 12138500 | 7 | Crohn's disease |
| 121385002 | 12138500 | 8 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121385002 | 12138500 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121385002 | 12138500 | Eating disorder | |
| 121385002 | 12138500 | Frequent bowel movements | |
| 121385002 | 12138500 | Haemorrhage | |
| 121385002 | 12138500 | Mass | |
| 121385002 | 12138500 | Off label use | |
| 121385002 | 12138500 | Pain | |
| 121385002 | 12138500 | Postoperative wound infection | |
| 121385002 | 12138500 | Product use issue | |
| 121385002 | 12138500 | Treatment noncompliance | |
| 121385002 | 12138500 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 121385002 | 12138500 | 1 | 20160905 | 0 | ||
| 121385002 | 12138500 | 2 | 20160705 | 0 | ||
| 121385002 | 12138500 | 3 | 20150827 | 0 | ||
| 121385002 | 12138500 | 4 | 20151201 | 0 | ||
| 121385002 | 12138500 | 5 | 20160905 | 0 | ||
| 121385002 | 12138500 | 6 | 20160705 | 0 | ||
| 121385002 | 12138500 | 7 | 20151201 | 0 | ||
| 121385002 | 12138500 | 8 | 20150827 | 0 |