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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109549114 | 10954911 | 4 | F | 2015 | 20160630 | 20150325 | 20160707 | EXP | PHHY2015BR034753 | NOVARTIS | 75.87 | YR | F | Y | 63.00000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109549114 | 10954911 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 109549114 | 10954911 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 109549114 | 10954911 | 3 | SS | TANDRILAX | ACETAMINOPHENCAFFEINECARISOPRODOLDICLOFENAC SODIUM | 1 | Unknown | U | 0 | TABLET | |||||||||
| 109549114 | 10954911 | 4 | C | CALCIUM | CALCIUM | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 109549114 | 10954911 | 5 | C | PROLOPA | BENSERAZIDELEVODOPA | 1 | Oral | 4 DF, QD | 0 | 4 | DF | TABLET | QD | ||||||
| 109549114 | 10954911 | 6 | C | SIFROL | PRAMIPEXOLE | 1 | Oral | 3 DF, QD | 0 | 3 | DF | TABLET | QD | ||||||
| 109549114 | 10954911 | 7 | C | NIAR | 2 | Oral | 2 DF, QD (1 YEAR AGO) | 0 | 2 | DF | TABLET | QD | |||||||
| 109549114 | 10954911 | 8 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 2 DF, QD (1 MONTH AGO) | 0 | 2 | DF | TABLET | QD | ||||||
| 109549114 | 10954911 | 9 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 10 DROPS, PER NIGHT | 0 | 10 | GTT | DROP | QD | ||||||
| 109549114 | 10954911 | 10 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 109549114 | 10954911 | 11 | C | ASA | ASPIRIN | 1 | Oral | 1 DF, QD (1 MONTH AGO) | 0 | 1 | DF | TABLET | QD | ||||||
| 109549114 | 10954911 | 12 | C | DIOSMIN | DIOSMIN | 1 | Oral | 1 ENVELOPE (900/100 MG), QD IN THE MORNING (STARTED 1 YEAR AGO)) | 0 | 1 | DF | QD | |||||||
| 109549114 | 10954911 | 13 | C | SINVASTATINA | SIMVASTATIN | 1 | Oral | 1 DF, QD (A FEW YEARS AGO) | 0 | 1 | DF | TABLET | QD | ||||||
| 109549114 | 10954911 | 14 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 1 DF, QD (A FEW YEARS AGO) | 0 | 1 | DF | TABLET | QD | ||||||
| 109549114 | 10954911 | 15 | C | MODURETIC 5-50 | AMILORIDE HYDROCHLORIDEHYDROCHLOROTHIAZIDE | 1 | Oral | 1 DF, QD (A FEW YEARS AGO) | 0 | 1 | DF | TABLET | QD | ||||||
| 109549114 | 10954911 | 16 | C | MANTIDAN | AMANTADINE HYDROCHLORIDE | 1 | Oral | 2 DF, QD (A FEW YEARS AGO) | 0 | 2 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109549114 | 10954911 | 1 | Osteoporosis |
| 109549114 | 10954911 | 3 | Product used for unknown indication |
| 109549114 | 10954911 | 4 | Osteopenia |
| 109549114 | 10954911 | 5 | Parkinson's disease |
| 109549114 | 10954911 | 6 | Parkinson's disease |
| 109549114 | 10954911 | 7 | Parkinson's disease |
| 109549114 | 10954911 | 8 | Prophylaxis |
| 109549114 | 10954911 | 9 | Sleep disorder |
| 109549114 | 10954911 | 10 | Prophylaxis |
| 109549114 | 10954911 | 11 | Anticoagulant therapy |
| 109549114 | 10954911 | 12 | Cardiovascular disorder |
| 109549114 | 10954911 | 13 | Prophylaxis |
| 109549114 | 10954911 | 14 | Hypertension |
| 109549114 | 10954911 | 15 | Diuretic therapy |
| 109549114 | 10954911 | 16 | Parkinson's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109549114 | 10954911 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109549114 | 10954911 | Abdominal discomfort | |
| 109549114 | 10954911 | Arthralgia | |
| 109549114 | 10954911 | Back pain | |
| 109549114 | 10954911 | Body height decreased | |
| 109549114 | 10954911 | Bone pain | |
| 109549114 | 10954911 | Decreased appetite | |
| 109549114 | 10954911 | Fall | |
| 109549114 | 10954911 | Feeling hot | |
| 109549114 | 10954911 | Fractured coccyx | |
| 109549114 | 10954911 | Gait disturbance | |
| 109549114 | 10954911 | Muscular weakness | |
| 109549114 | 10954911 | Pain | |
| 109549114 | 10954911 | Peripheral swelling | |
| 109549114 | 10954911 | Spinal disorder | |
| 109549114 | 10954911 | Spinal pain | |
| 109549114 | 10954911 | Tremor | |
| 109549114 | 10954911 | 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 |
|---|---|---|---|---|---|---|
| 109549114 | 10954911 | 1 | 2011 | 0 | ||
| 109549114 | 10954911 | 2 | 20150115 | 0 | ||
| 109549114 | 10954911 | 4 | 2002 | 0 | ||
| 109549114 | 10954911 | 5 | 2002 | 0 | ||
| 109549114 | 10954911 | 6 | 2002 | 0 |