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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101590913 | 10159091 | 3 | F | 20120807 | 20160818 | 20140508 | 20160823 | EXP | BR-ROCHE-1102037 | ROCHE | 33.84 | YR | F | Y | 47.00000 | KG | 20160823 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101590913 | 10159091 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 500MG/50ML | HO824B05 | 103705 | SOLUTION FOR INFUSION | ||||||||
| 101590913 | 10159091 | 2 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | LATEST INFUSION : JAN/2016 | HO824B05 | 103705 | SOLUTION FOR INFUSION | ||||||||
| 101590913 | 10159091 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 101590913 | 10159091 | 4 | C | REUQUINOL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 0 | 400 | MG | |||||||||
| 101590913 | 10159091 | 5 | C | PAROXETINE. | PAROXETINE | 1 | Unknown | 0 | 20 | MG | |||||||||
| 101590913 | 10159091 | 6 | C | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0 | 1 | MG | |||||||||
| 101590913 | 10159091 | 7 | C | PREGABALIN. | PREGABALIN | 1 | Unknown | 0 | 75 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 101590913 | 10159091 | 1 | Rheumatoid arthritis |
| 101590913 | 10159091 | 2 | Sjogren's syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 101590913 | 10159091 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 101590913 | 10159091 | Flatulence | |
| 101590913 | 10159091 | Headache | |
| 101590913 | 10159091 | Skin test positive |
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 |
|---|---|---|---|---|---|---|
| 101590913 | 10159091 | 1 | 20120806 | 0 | ||
| 101590913 | 10159091 | 2 | 20130415 | 0 |