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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118098403 | 11809840 | 3 | F | 20140702 | 20160727 | 20151208 | 20160729 | EXP | CA-ROCHE-1429353 | ROCHE | 55.52 | YR | M | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118098403 | 11809840 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20383 | 125276 | 800 | MG | SOLUTION FOR INFUSION | |||||||
| 118098403 | 11809840 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Subcutaneous | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||||
| 118098403 | 11809840 | 3 | C | KADIAN | MORPHINE SULFATE | 1 | 0 | ||||||||||||
| 118098403 | 11809840 | 4 | C | CESAMET | NABILONE | 1 | 0 | ||||||||||||
| 118098403 | 11809840 | 5 | C | OXYCODONE | OXYCODONE | 1 | 0 | ||||||||||||
| 118098403 | 11809840 | 6 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | 0 | ||||||||||||
| 118098403 | 11809840 | 7 | C | COZAAR | LOSARTAN POTASSIUM | 1 | 0 | ||||||||||||
| 118098403 | 11809840 | 8 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 118098403 | 11809840 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | 0 | ||||||||||||
| 118098403 | 11809840 | 10 | C | MELOXICAM. | MELOXICAM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118098403 | 11809840 | 1 | Rheumatoid arthritis |
| 118098403 | 11809840 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118098403 | 11809840 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118098403 | 11809840 | Atrial fibrillation | |
| 118098403 | 11809840 | Cardiac disorder | |
| 118098403 | 11809840 | Drug ineffective | |
| 118098403 | 11809840 | Heart rate decreased | |
| 118098403 | 11809840 | Influenza | |
| 118098403 | 11809840 | Infusion related reaction | |
| 118098403 | 11809840 | Injection site bruising | |
| 118098403 | 11809840 | Injection site haemorrhage | |
| 118098403 | 11809840 | 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 |
|---|---|---|---|---|---|---|
| 118098403 | 11809840 | 1 | 20140604 | 20140702 | 0 | |
| 118098403 | 11809840 | 2 | 20140723 | 0 |