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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108013668 | 10801366 | 8 | F | 2015 | 20160825 | 20150217 | 20160829 | EXP | CA-ROCHE-1536217 | ROCHE | 51.17 | YR | F | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108013668 | 10801366 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | U | 103705 | SOLUTION FOR INFUSION | |||||||||
| 108013668 | 10801366 | 2 | SS | RITUXAN | RITUXIMAB | 1 | U | 103705 | |||||||||||
| 108013668 | 10801366 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 108013668 | 10801366 | 4 | C | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | 0 | 50 | MG | |||||||||
| 108013668 | 10801366 | 5 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 108013668 | 10801366 | 6 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108013668 | 10801366 | 1 | Polymyositis |
| 108013668 | 10801366 | 2 | Dermatomyositis |
| 108013668 | 10801366 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108013668 | 10801366 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108013668 | 10801366 | Arthralgia | |
| 108013668 | 10801366 | Bronchitis | |
| 108013668 | 10801366 | Chest injury | |
| 108013668 | 10801366 | Diplopia | |
| 108013668 | 10801366 | Ill-defined disorder | |
| 108013668 | 10801366 | Myasthenia gravis | |
| 108013668 | 10801366 | Off label use | |
| 108013668 | 10801366 | Pain | |
| 108013668 | 10801366 | Thymoma | |
| 108013668 | 10801366 | Viral 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 |
|---|---|---|---|---|---|---|
| 108013668 | 10801366 | 1 | 20140813 | 0 | ||
| 108013668 | 10801366 | 5 | 20150522 | 0 | ||
| 108013668 | 10801366 | 6 | 20150522 | 0 |