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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
100168404 | 10016840 | 4 | F | 201312 | 20160808 | 20140318 | 20160810 | EXP | BR-ROCHE-1347922 | ROCHE | 30.32 | YR | F | Y | 52.00000 | KG | 20160810 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
100168404 | 10016840 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | SOLUTION FOR INFUSION | /yr | |||||||||
100168404 | 10016840 | 2 | SS | MABTHERA | RITUXIMAB | 1 | 103705 | ||||||||||||
100168404 | 10016840 | 3 | SS | MABTHERA | RITUXIMAB | 1 | 103705 | ||||||||||||
100168404 | 10016840 | 4 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
100168404 | 10016840 | 1 | Rheumatoid arthritis |
100168404 | 10016840 | 2 | Systemic scleroderma |
100168404 | 10016840 | 3 | Pulmonary fibrosis |
100168404 | 10016840 | 4 | Gastric disorder |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
100168404 | 10016840 | DE |
100168404 | 10016840 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
100168404 | 10016840 | Blood pressure increased | |
100168404 | 10016840 | Depression | |
100168404 | 10016840 | Off label use | |
100168404 | 10016840 | Pyrexia | |
100168404 | 10016840 | Respiratory failure | |
100168404 | 10016840 | Somnolence |
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 |
---|---|---|---|---|---|---|
100168404 | 10016840 | 1 | 20131118 | 20150815 | 0 |