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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116256273 | 11625627 | 3 | F | 2011 | 20160919 | 20151013 | 20160926 | EXP | BR-JNJFOC-20151007028 | JANSSEN | 0.00 | A | F | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116256273 | 11625627 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;FKL97013;FFL51013A | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 116256273 | 11625627 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;FKL97013;FFL51013A | 0 | LYOPHILIZED POWDER | ||||||||
| 116256273 | 11625627 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;FKL97013;FFL51013A | 0 | LYOPHILIZED POWDER | ||||||||
| 116256273 | 11625627 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 5 VIALS | N | UNKNOWN;FKL97013;FFL51013A | 103772 | LYOPHILIZED POWDER | |||||||
| 116256273 | 11625627 | 5 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 116256273 | 11625627 | 6 | C | MESALAZINE | MESALAMINE | 1 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116256273 | 11625627 | 1 | Crohn's disease |
| 116256273 | 11625627 | 2 | Crohn's disease |
| 116256273 | 11625627 | 3 | Crohn's disease |
| 116256273 | 11625627 | 4 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116256273 | 11625627 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116256273 | 11625627 | Crohn's disease | |
| 116256273 | 11625627 | Diarrhoea haemorrhagic | |
| 116256273 | 11625627 | Drug dose omission | |
| 116256273 | 11625627 | Drug ineffective | |
| 116256273 | 11625627 | Inappropriate schedule of drug administration | |
| 116256273 | 11625627 | Oedema | |
| 116256273 | 11625627 | Off label use | |
| 116256273 | 11625627 | Pain | |
| 116256273 | 11625627 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 116256273 | 11625627 | 2 | 20160714 | 0 | ||
| 116256273 | 11625627 | 3 | 2011 | 0 | ||
| 116256273 | 11625627 | 4 | 2011 | 0 |