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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125385363 | 12538536 | 3 | F | 20160818 | 20160708 | 20160822 | PER | PHEH2016US016458 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160822 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125385363 | 12538536 | 1 | PS | DIOVAN | VALSARTAN | 1 | Unknown | 80 MG, QD | U | K0186, K0188 | 21283 | 80 | MG | TABLET | QD | ||||
| 125385363 | 12538536 | 2 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | U | 0 | ||||||||||
| 125385363 | 12538536 | 3 | C | MULTI-B /06345501/ | 2 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125385363 | 12538536 | 1 | Product used for unknown indication |
| 125385363 | 12538536 | 2 | Product used for unknown indication |
| 125385363 | 12538536 | 3 | Abdominal discomfort |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125385363 | 12538536 | Cough | |
| 125385363 | 12538536 | Dizziness | |
| 125385363 | 12538536 | Feeling abnormal | |
| 125385363 | 12538536 | Influenza | |
| 125385363 | 12538536 | Muscular weakness | |
| 125385363 | 12538536 | Nervousness | |
| 125385363 | 12538536 | Product colour issue | |
| 125385363 | 12538536 | Pyrexia | |
| 125385363 | 12538536 | Tremor |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |