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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122635844 | 12263584 | 4 | F | 20160120 | 20160920 | 20160413 | 20160928 | EXP | JP-GILEAD-2016-0207311 | GILEAD | 79.00 | YR | E | M | Y | 62.10000 | KG | 20160928 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122635844 | 12263584 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 16400 | MG | Y | 204671 | 400 | MG | TABLET | QD | |||
| 122635844 | 12263584 | 2 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 200 MG, BID | 16400 | MG | Y | 0 | 200 | MG | CAPSULE | BID | |||
| 122635844 | 12263584 | 3 | C | DOXAZOSIN | DOXAZOSINDOXAZOSIN MESYLATE | 1 | Oral | 2 MG, QD | 0 | 2 | MG | TABLET | QD | ||||||
| 122635844 | 12263584 | 4 | C | TRAZENTA | LINAGLIPTIN | 1 | Oral | 5 MG, QD | 0 | 5 | MG | TABLET | QD | ||||||
| 122635844 | 12263584 | 5 | C | BAYASPIRIN | ASPIRIN | 1 | Oral | 100 MG, QD | 0 | 100 | MG | TABLET | QD | ||||||
| 122635844 | 12263584 | 6 | C | FEBURIC | FEBUXOSTAT | 1 | Oral | 10 MG, QD | 0 | 10 | MG | TABLET | QD | ||||||
| 122635844 | 12263584 | 7 | C | ATORVASTATIN /01326102/ | ATORVASTATIN | 1 | Oral | 5 MG, QD | 0 | 5 | MG | TABLET | QD | ||||||
| 122635844 | 12263584 | 8 | C | BETANIS | MIRABEGRON | 1 | Oral | 50 MG, QD | 0 | 50 | MG | TABLET | QD | ||||||
| 122635844 | 12263584 | 9 | C | CILNIDIPINE | CILNIDIPINE | 1 | Oral | 10 MG, BID | 0 | 10 | MG | TABLET | BID | ||||||
| 122635844 | 12263584 | 10 | C | MICARDIS | TELMISARTAN | 1 | Oral | 40 MG, BID | 0 | 40 | MG | TABLET | BID | ||||||
| 122635844 | 12263584 | 11 | C | ADALAT | NIFEDIPINE | 1 | Oral | 10 MG, BID | 0 | 10 | MG | TABLET | BID | ||||||
| 122635844 | 12263584 | 12 | C | MOHRUS L | KETOPROFEN | 1 | Transdermal | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 122635844 | 12263584 | 13 | C | ATEDIO | 2 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | |||||||
| 122635844 | 12263584 | 14 | C | DIOVAN | VALSARTAN | 1 | Oral | 40 MG, QD | 0 | 40 | MG | TABLET | QD | ||||||
| 122635844 | 12263584 | 15 | C | ARTIST | CARVEDILOL | 1 | Oral | 10 MG, QD | 0 | 10 | MG | TABLET | QD | ||||||
| 122635844 | 12263584 | 16 | C | FRANDOL | ISOSORBIDE DINITRATE | 1 | Transdermal | 40 MG, QD | 0 | 40 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122635844 | 12263584 | 1 | Chronic hepatitis C |
| 122635844 | 12263584 | 2 | Chronic hepatitis C |
| 122635844 | 12263584 | 3 | Hypertension |
| 122635844 | 12263584 | 4 | Type 2 diabetes mellitus |
| 122635844 | 12263584 | 6 | Hyperuricaemia |
| 122635844 | 12263584 | 7 | Hyperlipidaemia |
| 122635844 | 12263584 | 8 | Hypertonic bladder |
| 122635844 | 12263584 | 9 | Hypertension |
| 122635844 | 12263584 | 10 | Hypertension |
| 122635844 | 12263584 | 11 | Hypertension |
| 122635844 | 12263584 | 12 | Cervicobrachial syndrome |
| 122635844 | 12263584 | 13 | Hypertension |
| 122635844 | 12263584 | 14 | Hypertension |
| 122635844 | 12263584 | 15 | Hypertension |
| 122635844 | 12263584 | 16 | Myocardial ischaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122635844 | 12263584 | HO |
| 122635844 | 12263584 | LT |
| 122635844 | 12263584 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122635844 | 12263584 | Blood pressure decreased | |
| 122635844 | 12263584 | Constipation | |
| 122635844 | 12263584 | Decreased appetite | |
| 122635844 | 12263584 | Malaise | |
| 122635844 | 12263584 | Nasopharyngitis | |
| 122635844 | 12263584 | Nephrogenic anaemia | |
| 122635844 | 12263584 | Pneumonia | |
| 122635844 | 12263584 | Sinus arrest |
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 |
|---|---|---|---|---|---|---|
| 122635844 | 12263584 | 1 | 20160107 | 20160217 | 0 | |
| 122635844 | 12263584 | 2 | 20160107 | 20160217 | 0 | |
| 122635844 | 12263584 | 6 | 20160316 | 0 | ||
| 122635844 | 12263584 | 9 | 20160224 | 0 | ||
| 122635844 | 12263584 | 12 | 20160120 | 0 | ||
| 122635844 | 12263584 | 13 | 20160224 | 0 | ||
| 122635844 | 12263584 | 14 | 20160224 | 20160302 | 0 | |
| 122635844 | 12263584 | 15 | 20160302 | 0 | ||
| 122635844 | 12263584 | 16 | 20160316 | 0 |