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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 849766221 | 8497662 | 21 | F | 20120120 | 20160829 | 20120406 | 20160831 | EXP | CA-ROCHE-1052543 | ROCHE | 67.52 | YR | F | Y | 69.90000 | KG | 20160831 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 849766221 | 8497662 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 125276 | 560 | MG | SOLUTION FOR INFUSION | ||||||||
| 849766221 | 8497662 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | DOSE DECREASED | 125276 | 4 | MG/KG | SOLUTION FOR INFUSION | |||||||
| 849766221 | 8497662 | 3 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | H06453,H06573,N3694 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 849766221 | 8497662 | 4 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | H06453,H06573,N3694 | 103705 | SOLUTION FOR INFUSION | |||||||||
| 849766221 | 8497662 | 5 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | H06453,H06573,N3694 | 103705 | SOLUTION FOR INFUSION | |||||||||
| 849766221 | 8497662 | 6 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | 0 | |||||||||||
| 849766221 | 8497662 | 7 | SS | CELEBREX | CELECOXIB | 1 | Unknown | U | 0 | ||||||||||
| 849766221 | 8497662 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 849766221 | 8497662 | 9 | C | SULFASALAZINE. | SULFASALAZINE | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 10 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 11 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 12 | C | RISEDRONATE | RISEDRONATE SODIUM | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 13 | C | NAPROXEN. | NAPROXEN | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 14 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 849766221 | 8497662 | 15 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 849766221 | 8497662 | 16 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 849766221 | 8497662 | 17 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 18 | C | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 19 | C | MICARDIS | TELMISARTAN | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 20 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 21 | C | ZOPICLONE | ZOPICLONE | 1 | 0 | ||||||||||||
| 849766221 | 8497662 | 22 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 849766221 | 8497662 | 1 | Rheumatoid arthritis |
| 849766221 | 8497662 | 3 | Rheumatoid arthritis |
| 849766221 | 8497662 | 6 | Rheumatoid arthritis |
| 849766221 | 8497662 | 7 | Back pain |
| 849766221 | 8497662 | 8 | Back pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 849766221 | 8497662 | OT |
| 849766221 | 8497662 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 849766221 | 8497662 | Benign neoplasm | |
| 849766221 | 8497662 | Blister | |
| 849766221 | 8497662 | Blood pressure increased | |
| 849766221 | 8497662 | Contusion | |
| 849766221 | 8497662 | Diarrhoea | |
| 849766221 | 8497662 | Fatigue | |
| 849766221 | 8497662 | Full blood count abnormal | |
| 849766221 | 8497662 | Hypertension | |
| 849766221 | 8497662 | Infusion related reaction | |
| 849766221 | 8497662 | Nasopharyngitis | |
| 849766221 | 8497662 | Osteonecrosis | |
| 849766221 | 8497662 | Pain | |
| 849766221 | 8497662 | Peripheral swelling | |
| 849766221 | 8497662 | Pneumocystis jirovecii pneumonia | |
| 849766221 | 8497662 | Tooth infection | |
| 849766221 | 8497662 | Treatment failure | |
| 849766221 | 8497662 | Upper respiratory 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 |
|---|---|---|---|---|---|---|
| 849766221 | 8497662 | 1 | 20111117 | 20120711 | 0 | |
| 849766221 | 8497662 | 2 | 20120921 | 0 | ||
| 849766221 | 8497662 | 3 | 20130819 | 0 | ||
| 849766221 | 8497662 | 4 | 20150407 | 0 | ||
| 849766221 | 8497662 | 5 | 20150505 | 0 | ||
| 849766221 | 8497662 | 14 | 20130819 | 0 | ||
| 849766221 | 8497662 | 15 | 20130819 | 20141007 | 0 | |
| 849766221 | 8497662 | 16 | 20130819 | 0 | ||
| 849766221 | 8497662 | 22 | 20130823 | 0 |