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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
118444852 | 11844485 | 2 | F | 20150609 | 20160718 | 20151217 | 20160719 | EXP | IT-ROCHE-1678596 | ROCHE | 47.51 | YR | F | Y | 100.00000 | KG | 20160720 | MD | IT | IT |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
118444852 | 11844485 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 500MG 1 VIAL OF 50ML, CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION | Y | 103705 | 500 | MG | SOLUTION FOR INFUSION | /cycle | |||||
118444852 | 11844485 | 2 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 500MG 1 VIAL OF 50ML | Y | 103705 | 500 | MG | SOLUTION FOR INFUSION | /cycle | |||||
118444852 | 11844485 | 3 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | 200 MG COATED TABLETS' 30 TABLETS | 0 | 400 | MG | TABLET | |||||||
118444852 | 11844485 | 4 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | '5 MG TABLETS' 28 TABLETS | 0 | 5 | MG | TABLET | |||||||
118444852 | 11844485 | 5 | C | TRIATEC (ITALY) | RAMIPRIL | 1 | Oral | '5 MG TABLETS' 14 SCORED TABLETS | 0 | 10 | MG | TABLET | |||||||
118444852 | 11844485 | 6 | C | ZUGLIMET | METFORMIN HYDROCHLORIDE | 1 | Oral | '500 MG FILM-COATED TABLETS' 30 TABLETS | 0 | 1500 | MG | FILM-COATED TABLET | |||||||
118444852 | 11844485 | 7 | C | DELTACORTENE | PREDNISONE | 1 | Oral | '25 MG TABLETS' 10 TABLETS | 0 | 25 | MG | TABLET |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
118444852 | 11844485 | 1 | Systemic lupus erythematosus |
118444852 | 11844485 | 3 | Sjogren's syndrome |
118444852 | 11844485 | 4 | Hypertension |
118444852 | 11844485 | 5 | Hypertension |
118444852 | 11844485 | 6 | Diabetes mellitus |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
118444852 | 11844485 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
118444852 | 11844485 | C-reactive protein increased | |
118444852 | 11844485 | Hyperpyrexia | |
118444852 | 11844485 | Musculoskeletal pain | |
118444852 | 11844485 | Off label use |
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 |
---|---|---|---|---|---|---|
118444852 | 11844485 | 1 | 20150525 | 20150525 | 0 | |
118444852 | 11844485 | 2 | 20150707 | 20150707 | 0 | |
118444852 | 11844485 | 3 | 20150528 | 0 | ||
118444852 | 11844485 | 4 | 20150528 | 0 | ||
118444852 | 11844485 | 5 | 20150528 | 0 | ||
118444852 | 11844485 | 6 | 20150528 | 0 | ||
118444852 | 11844485 | 7 | 20150528 | 0 |