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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126365183 | 12636518 | 3 | F | 20150819 | 20160907 | 20160809 | 20160916 | EXP | DE-GILEAD-2016-0218557 | GILEAD | 39.00 | YR | A | M | Y | 80.00000 | KG | 20160916 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126365183 | 12636518 | 1 | PS | LEDIPASVIR/SOFOSBUVIR | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, QD | U | 205834 | 1 | DF | TABLET | QD | |||||
| 126365183 | 12636518 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 600 MG, QD | Y | 0 | 600 | MG | QD | ||||||
| 126365183 | 12636518 | 3 | SS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 126365183 | 12636518 | 4 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | U | 0 | ||||||||||
| 126365183 | 12636518 | 5 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | U | 0 | ||||||||||
| 126365183 | 12636518 | 6 | SS | HCT | HYDROCHLOROTHIAZIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126365183 | 12636518 | 1 | Chronic hepatitis C |
| 126365183 | 12636518 | 2 | Chronic hepatitis C |
| 126365183 | 12636518 | 3 | Product used for unknown indication |
| 126365183 | 12636518 | 4 | Product used for unknown indication |
| 126365183 | 12636518 | 5 | Product used for unknown indication |
| 126365183 | 12636518 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126365183 | 12636518 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126365183 | 12636518 | Affective disorder | |
| 126365183 | 12636518 | Ascites | |
| 126365183 | 12636518 | Blood pressure fluctuation | |
| 126365183 | 12636518 | Constipation | |
| 126365183 | 12636518 | Decreased appetite | |
| 126365183 | 12636518 | Dizziness | |
| 126365183 | 12636518 | Fatigue | |
| 126365183 | 12636518 | Headache | |
| 126365183 | 12636518 | Nausea | |
| 126365183 | 12636518 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 126365183 | 12636518 | 1 | 20150722 | 20160105 | 0 | |
| 126365183 | 12636518 | 2 | 20150722 | 20160105 | 0 |