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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116317505 | 11631750 | 5 | F | 201405 | 20160705 | 20151015 | 20160707 | EXP | CA-ROCHE-1389860 | ROCHE | 49.98 | YR | F | Y | 85.00000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116317505 | 11631750 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | U | B20213,B20303,B20243 | 125276 | 304 | MG | INFUSION | ||||||
| 116317505 | 11631750 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | U | B20213,B20303,B20243 | 125276 | 680 | MG | INFUSION | ||||||
| 116317505 | 11631750 | 3 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DAY 1, 15 | N3701,N3722B02,N3728B07 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | ||||||
| 116317505 | 11631750 | 4 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 116317505 | 11631750 | 5 | C | CANDESARTAN | CANDESARTAN | 1 | 0 | ||||||||||||
| 116317505 | 11631750 | 6 | C | NAPROXEN. | NAPROXEN | 1 | 0 | ||||||||||||
| 116317505 | 11631750 | 7 | C | VITAMIN C | ASCORBIC ACID | 1 | 0 | ||||||||||||
| 116317505 | 11631750 | 8 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | 0 | ||||||||||||
| 116317505 | 11631750 | 9 | C | AMOXICILLIN. | AMOXICILLIN | 1 | 0 | ||||||||||||
| 116317505 | 11631750 | 10 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 116317505 | 11631750 | 11 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 116317505 | 11631750 | 12 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116317505 | 11631750 | 1 | Rheumatoid arthritis |
| 116317505 | 11631750 | 3 | Rheumatoid arthritis |
| 116317505 | 11631750 | 4 | Blood cholesterol increased |
| 116317505 | 11631750 | 5 | Blood pressure measurement |
| 116317505 | 11631750 | 6 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116317505 | 11631750 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116317505 | 11631750 | Blood cholesterol increased | |
| 116317505 | 11631750 | Blood pressure fluctuation | |
| 116317505 | 11631750 | Cough | |
| 116317505 | 11631750 | Heart rate increased | |
| 116317505 | 11631750 | Hepatic enzyme increased | |
| 116317505 | 11631750 | Influenza | |
| 116317505 | 11631750 | Influenza like illness | |
| 116317505 | 11631750 | Infusion related reaction | |
| 116317505 | 11631750 | Nasopharyngitis | |
| 116317505 | 11631750 | Productive cough | |
| 116317505 | 11631750 | Skin ulcer | |
| 116317505 | 11631750 | Type 2 diabetes mellitus | |
| 116317505 | 11631750 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 116317505 | 11631750 | 1 | 20140226 | 0 | ||
| 116317505 | 11631750 | 2 | 20140818 | 20150309 | 0 | |
| 116317505 | 11631750 | 3 | 20150514 | 0 | ||
| 116317505 | 11631750 | 4 | 20140908 | 0 | ||
| 116317505 | 11631750 | 10 | 20150514 | 0 | ||
| 116317505 | 11631750 | 11 | 20150514 | 0 | ||
| 116317505 | 11631750 | 12 | 20150514 | 0 |