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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125383011 | 12538301 | 1 | I | 201512 | 20160629 | 20160707 | 20160707 | EXP | FR-GILEAD-2016-0221440 | GILEAD | 69.00 | YR | E | M | Y | 0.00000 | 20160707 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125383011 | 12538301 | 1 | PS | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, QD | 205834 | 1 | DF | TABLET | QD | ||||||
| 125383011 | 12538301 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 400 MG, BID | 0 | 400 | MG | BID | |||||||
| 125383011 | 12538301 | 3 | C | KAYEXALATE | SODIUM POLYSTYRENE SULFONATE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 4 | C | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 5 | C | NOVONORM | REPAGLINIDE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 6 | C | TAHOR | ATORVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 7 | C | ONGLYZA | SAXAGLIPTIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 8 | C | COAPROVEL | HYDROCHLOROTHIAZIDEIRBESARTAN | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 9 | C | KARDEGIC | ASPIRIN LYSINE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 10 | C | LERCAN | LERCANIDIPINE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 11 | C | TEMERIT | NEBIVOLOL | 1 | Y | 0 | |||||||||||
| 125383011 | 12538301 | 12 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 13 | C | LANTUS | INSULIN GLARGINE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 14 | C | SERESTA | OXAZEPAM | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 15 | C | SEROPLEX | ESCITALOPRAM OXALATE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 16 | C | ADENURIC | FEBUXOSTAT | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 17 | C | TARDYFERON | FERROUS SULFATE | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 18 | C | SPECIAFOLDINE | FOLIC ACID | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 19 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 | ||||||||||||
| 125383011 | 12538301 | 20 | C | RENUTRYL | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125383011 | 12538301 | 1 | Chronic hepatitis C |
| 125383011 | 12538301 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125383011 | 12538301 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125383011 | 12538301 | Bradycardia | |
| 125383011 | 12538301 | Malaise |
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 |
|---|---|---|---|---|---|---|
| 125383011 | 12538301 | 1 | 20151123 | 20160215 | 0 | |
| 125383011 | 12538301 | 2 | 20151123 | 20160215 | 0 |