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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95490403 | 9549040 | 3 | F | 201401 | 20160809 | 20130924 | 20160816 | EXP | CA-ROCHE-1279888 | ROCHE | 67.75 | YR | M | Y | 70.70000 | KG | 20160816 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95490403 | 9549040 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DAY 1 AND DAY 15 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 95490403 | 9549040 | 2 | SS | RITUXAN | RITUXIMAB | 1 | 103705 | ||||||||||||
| 95490403 | 9549040 | 3 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 50722 | |||||||||||
| 95490403 | 9549040 | 4 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 95490403 | 9549040 | 5 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 95490403 | 9549040 | 6 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 95490403 | 9549040 | 7 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 0 | ||||||||||||
| 95490403 | 9549040 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Oral | ALTERNATING DAYS | 0 | ||||||||||
| 95490403 | 9549040 | 9 | C | PREDNISONE. | PREDNISONE | 1 | Oral | ALTERNATING DAYS?CURRENT DOSE 10MG/DAY | 0 | ||||||||||
| 95490403 | 9549040 | 10 | C | NORVASC | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 95490403 | 9549040 | 11 | C | ZESTRIL | LISINOPRIL | 1 | 0 | ||||||||||||
| 95490403 | 9549040 | 12 | C | ACTONEL | RISEDRONATE SODIUM | 1 | Unknown | 0 | /month | ||||||||||
| 95490403 | 9549040 | 13 | C | MINOCYCLINE | MINOCYCLINEMINOCYCLINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 95490403 | 9549040 | 14 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | ALTERNATING DAYS | 0 | 81 | MG | ||||||||
| 95490403 | 9549040 | 15 | C | VITAMIN C | ASCORBIC ACID | 1 | 0 | ||||||||||||
| 95490403 | 9549040 | 16 | C | GLUTEN DIET | 2 | 0 | |||||||||||||
| 95490403 | 9549040 | 17 | C | GINKOBA | GINKGO | 1 | 0 | ||||||||||||
| 95490403 | 9549040 | 18 | C | IVIG | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | 0 | /month | ||||||||||
| 95490403 | 9549040 | 19 | C | POTASSIUM CITRATE. | POTASSIUM CITRATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 95490403 | 9549040 | 1 | Sjogren's syndrome |
| 95490403 | 9549040 | 2 | Autoimmune encephalopathy |
| 95490403 | 9549040 | 3 | Product used for unknown indication |
| 95490403 | 9549040 | 4 | Premedication |
| 95490403 | 9549040 | 5 | Premedication |
| 95490403 | 9549040 | 6 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 95490403 | 9549040 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 95490403 | 9549040 | Anastomotic ulcer | |
| 95490403 | 9549040 | Diarrhoea | |
| 95490403 | 9549040 | Encephalopathy | |
| 95490403 | 9549040 | Eye infection viral | |
| 95490403 | 9549040 | Fatigue | |
| 95490403 | 9549040 | Glucose tolerance impaired | |
| 95490403 | 9549040 | Off label use | |
| 95490403 | 9549040 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 95490403 | 9549040 | 1 | 20130430 | 0 | ||
| 95490403 | 9549040 | 4 | 20130430 | 0 | ||
| 95490403 | 9549040 | 5 | 20130430 | 0 | ||
| 95490403 | 9549040 | 6 | 20130430 | 0 |