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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123555663 | 12355566 | 3 | F | 20160504 | 20160630 | 20160511 | 20160714 | EXP | CA-JNJFOC-20160506859 | JANSSEN | 16.79 | YR | T | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123555663 | 12355566 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95011 | 0 | LYOPHILIZED POWDER | ||||||||
| 123555663 | 12355566 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95011 | 0 | 600 | MG | LYOPHILIZED POWDER | ||||||
| 123555663 | 12355566 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 7TH INFUSION | N | FKM95011 | 103772 | 600 | MG | LYOPHILIZED POWDER | |||||
| 123555663 | 12355566 | 4 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123555663 | 12355566 | 5 | C | MESALAZINE | MESALAMINE | 1 | Unknown | 0 | ENEMA | ||||||||||
| 123555663 | 12355566 | 6 | C | MESALAZINE | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123555663 | 12355566 | 7 | C | PROFERRIN | 2 | Unknown | 0 | UNSPECIFIED | |||||||||||
| 123555663 | 12355566 | 8 | C | BIPHENTIN | METHYLPHENIDATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123555663 | 12355566 | 9 | C | TRI-CYCLEN | ETHINYL ESTRADIOLNORGESTIMATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123555663 | 12355566 | 10 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123555663 | 12355566 | 1 | Colitis ulcerative |
| 123555663 | 12355566 | 2 | Colitis ulcerative |
| 123555663 | 12355566 | 3 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123555663 | 12355566 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123555663 | 12355566 | Frequent bowel movements | |
| 123555663 | 12355566 | General physical health deterioration | |
| 123555663 | 12355566 | Haematochezia | |
| 123555663 | 12355566 | Off label use | |
| 123555663 | 12355566 | 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 |
|---|---|---|---|---|---|---|
| 123555663 | 12355566 | 1 | 20150831 | 0 | ||
| 123555663 | 12355566 | 2 | 20160630 | 0 | ||
| 123555663 | 12355566 | 3 | 20160505 | 0 |