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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125995601 | 12599560 | 1 | I | 201512 | 20160719 | 20160727 | 20160727 | EXP | PHHY2016BR101544 | NOVARTIS | 54.46 | YR | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125995601 | 12599560 | 1 | PS | DIOVAN | VALSARTAN | 1 | Unknown | U | 20665 | ||||||||||
| 125995601 | 12599560 | 2 | SS | DIOVAN AMLO FIX | AMLODIPINEVALSARTAN | 1 | Oral | 1 DF (AMLODIPINE 5 MG, VALSARTAN 320 MG), QD | U | FC 435 | 0 | 1 | DF | TABLET | QD | ||||
| 125995601 | 12599560 | 3 | SS | DIOVAN HCT | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | Oral | 1 DF (HYDROCHOLROTHIAZIDE 12.5 MG, VALSARTAN 320 MG), QD | U | SC 123 | 0 | 1 | DF | TABLET | QD | ||||
| 125995601 | 12599560 | 4 | SS | IGROTON | CHLORTHALIDONE | 1 | Oral | 25 MG, QD | U | 1605188 | 0 | 25 | MG | TABLET | QD | ||||
| 125995601 | 12599560 | 5 | SS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | U | 15110807 | 0 | 5 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125995601 | 12599560 | 1 | Hypertension |
| 125995601 | 12599560 | 2 | Hypertension |
| 125995601 | 12599560 | 3 | Hypertension |
| 125995601 | 12599560 | 4 | Product used for unknown indication |
| 125995601 | 12599560 | 5 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125995601 | 12599560 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125995601 | 12599560 | Anxiety | |
| 125995601 | 12599560 | Blood cholesterol increased | |
| 125995601 | 12599560 | Blood pressure abnormal | |
| 125995601 | 12599560 | Body mass index abnormal | |
| 125995601 | 12599560 | Diabetes mellitus | |
| 125995601 | 12599560 | Drug administration error | |
| 125995601 | 12599560 | Malaise | |
| 125995601 | 12599560 | Nervousness | |
| 125995601 | 12599560 | 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 |
|---|---|---|---|---|---|---|
| 125995601 | 12599560 | 2 | 20151126 | 0 | ||
| 125995601 | 12599560 | 3 | 20151126 | 0 |