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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96975038 | 9697503 | 8 | F | 201508 | 20160803 | 20131120 | 20160805 | EXP | CA-ROCHE-1305299 | ROCHE | 76.64 | YR | F | Y | 0.00000 | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96975038 | 9697503 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | N3722 | 103705 | SOLUTION FOR INFUSION | |||||||||
| 96975038 | 9697503 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 500 MG/6 MONTHS ON 10/JUN/2014 | N3722 | 103705 | SOLUTION FOR INFUSION | ||||||||
| 96975038 | 9697503 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | ||||||||||
| 96975038 | 9697503 | 4 | C | NORVASC | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 96975038 | 9697503 | 5 | C | ACETYLSALICYLIC ACID | ASPIRIN | 1 | 0 | ||||||||||||
| 96975038 | 9697503 | 6 | C | IRBESARTAN. | IRBESARTAN | 1 | 0 | ||||||||||||
| 96975038 | 9697503 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 96975038 | 9697503 | 1 | Anti-neutrophil cytoplasmic antibody positive vasculitis |
| 96975038 | 9697503 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 96975038 | 9697503 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 96975038 | 9697503 | Alopecia | |
| 96975038 | 9697503 | Blood pressure diastolic decreased | |
| 96975038 | 9697503 | Blood pressure fluctuation | |
| 96975038 | 9697503 | Cough | |
| 96975038 | 9697503 | Dry skin | |
| 96975038 | 9697503 | Dysgeusia | |
| 96975038 | 9697503 | Erythema | |
| 96975038 | 9697503 | Eye swelling | |
| 96975038 | 9697503 | Fatigue | |
| 96975038 | 9697503 | Hallucination | |
| 96975038 | 9697503 | Heart rate decreased | |
| 96975038 | 9697503 | Infusion related reaction | |
| 96975038 | 9697503 | Lower respiratory tract congestion | |
| 96975038 | 9697503 | Mass | |
| 96975038 | 9697503 | Off label use | |
| 96975038 | 9697503 | Oxygen saturation decreased | |
| 96975038 | 9697503 | Pruritus | |
| 96975038 | 9697503 | Pulmonary mass | |
| 96975038 | 9697503 | Swelling face |
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 |
|---|---|---|---|---|---|---|
| 96975038 | 9697503 | 1 | 20131218 | 0 |