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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124256042 | 12425604 | 2 | F | 20160623 | 20160601 | 20160706 | EXP | PHHY2016BR066724 | NOVARTIS | 0.00 | F | Y | 74.00000 | KG | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124256042 | 12425604 | 1 | SS | DIOVAN | VALSARTAN | 1 | Oral | 1 DF, QD | Y | 0 | 1 | DF | TABLET | QD | |||||
| 124256042 | 12425604 | 2 | SS | RASILEZ | ALISKIREN | 1 | Unknown | 1 DF (300 MG), QD (28 TABLETS) | Y | TA037 | 0 | 1 | DF | TABLET | QD | ||||
| 124256042 | 12425604 | 3 | SS | EXFORGE HCT | AMLODIPINE BESYLATEHYDROCHLOROTHIAZIDEVALSARTAN | 1 | Oral | 1 DF (320 MG VALSARTAN, 25 MG AMLODIPINE AND 10 MG HYDROCHLOROTHIAZIDE), QD | U | SC150 | 0 | 1 | DF | FILM-COATED TABLET | QD | ||||
| 124256042 | 12425604 | 4 | SS | EXFORGE HCT | AMLODIPINE BESYLATEHYDROCHLOROTHIAZIDEVALSARTAN | 1 | Oral | 2 DF, (160 MG VALSARTAN, 12.5 MG AMLODIPINE AND 5 MG HYDROCHLOROTHIAZIE) | U | 0 | 2 | DF | FILM-COATED TABLET | ||||||
| 124256042 | 12425604 | 5 | PS | RASILEZ HCT | ALISKIRENHYDROCHLOROTHIAZIDE | 1 | Oral | 1 DF, QD | Y | 22107 | 1 | DF | TABLET | QD | |||||
| 124256042 | 12425604 | 6 | C | ESPRAN | ESCITALOPRAM OXALATE | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 124256042 | 12425604 | 7 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 1 DF, QD | Y | 0 | 1 | DF | TABLET | QD | |||||
| 124256042 | 12425604 | 8 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Y | 0 | TABLET | ||||||||||
| 124256042 | 12425604 | 9 | C | LIVALO | PITAVASTATIN CALCIUM | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 124256042 | 12425604 | 10 | C | LIVALO | PITAVASTATIN CALCIUM | 1 | 0 | TABLET | |||||||||||
| 124256042 | 12425604 | 11 | C | FLAVENOS | 2 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124256042 | 12425604 | 1 | Hypertension |
| 124256042 | 12425604 | 2 | Hypertension |
| 124256042 | 12425604 | 3 | Hypertension |
| 124256042 | 12425604 | 5 | Hypertension |
| 124256042 | 12425604 | 6 | Panic disorder |
| 124256042 | 12425604 | 7 | Blood cholesterol |
| 124256042 | 12425604 | 8 | Blood triglycerides increased |
| 124256042 | 12425604 | 9 | Blood cholesterol |
| 124256042 | 12425604 | 10 | Blood triglycerides increased |
| 124256042 | 12425604 | 11 | Peripheral swelling |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124256042 | 12425604 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124256042 | 12425604 | Blood pressure inadequately controlled | |
| 124256042 | 12425604 | Blood pressure increased | |
| 124256042 | 12425604 | Drug ineffective | |
| 124256042 | 12425604 | Fear |
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 |
|---|---|---|---|---|---|---|
| 124256042 | 12425604 | 2 | 20160430 | 0 | ||
| 124256042 | 12425604 | 3 | 20160430 | 0 | ||
| 124256042 | 12425604 | 5 | 20160430 | 0 |