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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116944893 | 11694489 | 3 | F | 20151016 | 20160714 | 20151103 | 20160721 | EXP | CA-JNJFOC-20151023563 | JANSSEN | 0.00 | A | F | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116944893 | 11694489 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 116944893 | 11694489 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 103772 | 3 | MG/KG | LYOPHILIZED POWDER | ||||||
| 116944893 | 11694489 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | Y | 0 | 10 | MG | UNSPECIFIED | /wk | ||||||
| 116944893 | 11694489 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | Y | 0 | 20 | MG | UNSPECIFIED | QD | ||||||
| 116944893 | 11694489 | 5 | C | ROSUVASTATIN. | ROSUVASTATIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 116944893 | 11694489 | 6 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116944893 | 11694489 | 1 | Rheumatoid arthritis |
| 116944893 | 11694489 | 2 | Rheumatoid arthritis |
| 116944893 | 11694489 | 3 | Rheumatoid arthritis |
| 116944893 | 11694489 | 4 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116944893 | 11694489 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116944893 | 11694489 | Hepatitis | |
| 116944893 | 11694489 | Jaundice | |
| 116944893 | 11694489 | Poisoning | |
| 116944893 | 11694489 | Rheumatoid arthritis |
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 |
|---|---|---|---|---|---|---|
| 116944893 | 11694489 | 2 | 20090625 | 20091022 | 0 | |
| 116944893 | 11694489 | 3 | 20080916 | 20091022 | 0 | |
| 116944893 | 11694489 | 4 | 20080916 | 20091022 | 0 |