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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120813692 | 12081369 | 2 | F | 20160809 | 20160216 | 20160812 | EXP | CA-009507513-1602CAN007215 | MERCK | 56.00 | YR | F | Y | 62.00000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120813692 | 12081369 | 1 | PS | COZAAR | LOSARTAN POTASSIUM | 1 | Oral | 100 MG, QD | U | 20386 | 100 | MG | TABLET | QD | |||||
| 120813692 | 12081369 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 10 MG, UNK | U | 0 | 10 | MG | TABLET | ||||||
| 120813692 | 12081369 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | U | 0 | TABLET | ||||||||
| 120813692 | 12081369 | 4 | SS | ACTONEL | RISEDRONATE SODIUM | 1 | Unknown | U | 0 | TABLET | |||||||||
| 120813692 | 12081369 | 5 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 0 | CAPSULE | |||||||||
| 120813692 | 12081369 | 6 | SS | RAMIPRIL. | RAMIPRIL | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 120813692 | 12081369 | 7 | SS | RAMIPRIL. | RAMIPRIL | 1 | Oral | 10 MG, BID | U | 0 | 10 | MG | BID | ||||||
| 120813692 | 12081369 | 8 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 1000 MG | U | 0 | 1000 | MG | SOLUTION FOR INJECTION/INFUSION | ||||||
| 120813692 | 12081369 | 9 | SS | RITUXAN | RITUXIMAB | 1 | U | 0 | SOLUTION FOR INJECTION/INFUSION | ||||||||||
| 120813692 | 12081369 | 10 | SS | RITUXAN | RITUXIMAB | 1 | U | 0 | SOLUTION FOR INJECTION/INFUSION | ||||||||||
| 120813692 | 12081369 | 11 | SS | RITUXAN | RITUXIMAB | 1 | U | 0 | SOLUTION FOR INJECTION/INFUSION | ||||||||||
| 120813692 | 12081369 | 12 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 1000 MG, UNK | U | 0 | 1000 | MG | |||||||
| 120813692 | 12081369 | 13 | SS | RITUXAN | RITUXIMAB | 1 | U | 0 | |||||||||||
| 120813692 | 12081369 | 14 | SS | RITUXAN | RITUXIMAB | 1 | U | 0 | |||||||||||
| 120813692 | 12081369 | 15 | SS | RITUXAN | RITUXIMAB | 1 | U | 0 | |||||||||||
| 120813692 | 12081369 | 16 | SS | SULFAMETHOXAZOLE | SULFAMETHOXAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 120813692 | 12081369 | 17 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 1000 MG, UNK | U | 0 | 1000 | MG | TABLET | ||||||
| 120813692 | 12081369 | 18 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 650 MG, UNK | U | 0 | 650 | MG | TABLET | ||||||
| 120813692 | 12081369 | 19 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 1000 MG, UNK | U | 0 | 1000 | MG | TABLET | ||||||
| 120813692 | 12081369 | 20 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 500 MG, UNK | U | 0 | 500 | MG | TABLET | ||||||
| 120813692 | 12081369 | 21 | C | ARANESP | DARBEPOETIN ALFA | 1 | Unknown | 30 MICROGRAM, BIW | U | 0 | 30 | UG | SOLUTION FOR INJECTION/INFUSION | BIW | |||||
| 120813692 | 12081369 | 22 | C | DIPHENHYDRAMINE HYDROCHLORIDE. | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 120813692 | 12081369 | 23 | C | docosahexaenoic acid (+) eicosapentaenoic acid | 2 | U | 0 | ||||||||||||
| 120813692 | 12081369 | 24 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 100 MG, UNK | U | 0 | 100 | MG | |||||||
| 120813692 | 12081369 | 25 | C | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 120813692 | 12081369 | 26 | C | TRIMETHOPRIM. | TRIMETHOPRIM | 1 | U | 0 | TABLET | ||||||||||
| 120813692 | 12081369 | 27 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | U | 0 | INJECTION | ||||||||||
| 120813692 | 12081369 | 28 | C | ZOPICLONE | ZOPICLONE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120813692 | 12081369 | 1 | Hypertension |
| 120813692 | 12081369 | 2 | Product used for unknown indication |
| 120813692 | 12081369 | 4 | Product used for unknown indication |
| 120813692 | 12081369 | 5 | Product used for unknown indication |
| 120813692 | 12081369 | 6 | Hypertension |
| 120813692 | 12081369 | 8 | Vasculitis |
| 120813692 | 12081369 | 9 | Sjogren's syndrome |
| 120813692 | 12081369 | 10 | Lupus nephritis |
| 120813692 | 12081369 | 11 | Cryoglobulinaemia |
| 120813692 | 12081369 | 12 | Vasculitis |
| 120813692 | 12081369 | 13 | Sjogren's syndrome |
| 120813692 | 12081369 | 14 | Lupus nephritis |
| 120813692 | 12081369 | 15 | Cryoglobulinaemia |
| 120813692 | 12081369 | 16 | Product used for unknown indication |
| 120813692 | 12081369 | 17 | Premedication |
| 120813692 | 12081369 | 22 | Premedication |
| 120813692 | 12081369 | 24 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120813692 | 12081369 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120813692 | 12081369 | Abdominal pain upper | |
| 120813692 | 12081369 | Blood pressure diastolic decreased | |
| 120813692 | 12081369 | Blood pressure increased | |
| 120813692 | 12081369 | Drug ineffective | |
| 120813692 | 12081369 | Headache | |
| 120813692 | 12081369 | Heart rate decreased | |
| 120813692 | 12081369 | Hypotension | |
| 120813692 | 12081369 | Insomnia | |
| 120813692 | 12081369 | Laboratory test abnormal | |
| 120813692 | 12081369 | Lupus nephritis | |
| 120813692 | 12081369 | Malaise | |
| 120813692 | 12081369 | Palpitations | |
| 120813692 | 12081369 | Sjogren's syndrome | |
| 120813692 | 12081369 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |