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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118062602 | 11806260 | 2 | F | 20141223 | 20160812 | 20151207 | 20160816 | EXP | CA-ROCHE-1512303 | ROCHE | 78.68 | YR | M | Y | 75.50000 | KG | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118062602 | 11806260 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2027,B2038,B2040,B2028,B2048,B2032 | 125276 | 332 | MG | SOLUTION FOR INFUSION | |||||||
| 118062602 | 11806260 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2027,B2038,B2040,B2028,B2048,B2032 | 125276 | 640 | MG | SOLUTION FOR INFUSION | |||||||
| 118062602 | 11806260 | 3 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 118062602 | 11806260 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 10 | MG | |||||||||
| 118062602 | 11806260 | 5 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 0 | 150 | MG | |||||||||
| 118062602 | 11806260 | 6 | C | ASA | ASPIRIN | 1 | Unknown | 0 | 81 | MG | QD | ||||||||
| 118062602 | 11806260 | 7 | C | ACTONEL | RISEDRONATE SODIUM | 1 | Unknown | 0 | 35 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118062602 | 11806260 | 1 | Temporal arteritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118062602 | 11806260 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118062602 | 11806260 | C-reactive protein increased | |
| 118062602 | 11806260 | Cataract | |
| 118062602 | 11806260 | Dry skin | |
| 118062602 | 11806260 | Hepatic enzyme increased | |
| 118062602 | 11806260 | Infusion related reaction | |
| 118062602 | 11806260 | Lipoma | |
| 118062602 | 11806260 | Middle ear effusion | |
| 118062602 | 11806260 | Musculoskeletal discomfort | |
| 118062602 | 11806260 | Off label use | |
| 118062602 | 11806260 | Oxygen saturation decreased | |
| 118062602 | 11806260 | Rash | |
| 118062602 | 11806260 | Skin warm | |
| 118062602 | 11806260 | Temporal arteritis | |
| 118062602 | 11806260 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 118062602 | 11806260 | 1 | 20141028 | 0 | ||
| 118062602 | 11806260 | 2 | 20150326 | 20160603 | 0 |