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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115040925 | 11504092 | 5 | F | 20150801 | 20160829 | 20150914 | 20160906 | EXP | DE-GILEAD-2015-0170708 | GILEAD | 45.00 | YR | A | M | Y | 100.00000 | KG | 20160906 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115040925 | 11504092 | 1 | PS | SOFOSBUVIR | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 11600 | MG | U | 204671 | 400 | MG | TABLET | QD | |||
| 115040925 | 11504092 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 600 MG, QD | 17400 | MG | Y | 0 | 600 | MG | QD | ||||
| 115040925 | 11504092 | 3 | SS | DACLATASVIR. | DACLATASVIR | 1 | Oral | 60 MG, QD | 1740 | MG | U | 0 | 60 | MG | QD | ||||
| 115040925 | 11504092 | 4 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | UNK, PRN | 0 | ||||||||||
| 115040925 | 11504092 | 5 | C | SPIRONOLACTON | SPIRONOLACTONE | 1 | Unknown | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 115040925 | 11504092 | 6 | C | SPIRONOLACTON | SPIRONOLACTONE | 1 | Oral | 50 MG, BID | 0 | 50 | MG | BID | |||||||
| 115040925 | 11504092 | 7 | C | FUROSEMID /00032601/ | FUROSEMIDE | 1 | Oral | 40 MG, BID | 0 | 40 | MG | BID | |||||||
| 115040925 | 11504092 | 8 | C | LIMPTAR | AMINOPHYLLINEQUININE SULFATE | 1 | Unknown | 200 MG, UNK | 0 | 200 | MG | ||||||||
| 115040925 | 11504092 | 9 | C | BISOPROLOL RATIOPHARM | BISOPROLOL | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115040925 | 11504092 | 1 | Chronic hepatitis C |
| 115040925 | 11504092 | 2 | Chronic hepatitis C |
| 115040925 | 11504092 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115040925 | 11504092 | OT |
| 115040925 | 11504092 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115040925 | 11504092 | Abdominal discomfort | |
| 115040925 | 11504092 | Ascites | |
| 115040925 | 11504092 | Drug ineffective | |
| 115040925 | 11504092 | Epistaxis | |
| 115040925 | 11504092 | Hepatitis C | |
| 115040925 | 11504092 | Hepatitis C RNA increased | |
| 115040925 | 11504092 | Oedema peripheral | |
| 115040925 | 11504092 | Peritonitis bacterial | |
| 115040925 | 11504092 | Viral mutation identified |
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 |
|---|---|---|---|---|---|---|
| 115040925 | 11504092 | 1 | 20150720 | 20160701 | 0 | |
| 115040925 | 11504092 | 2 | 20150720 | 20160701 | 0 | |
| 115040925 | 11504092 | 3 | 20150720 | 20160701 | 0 | |
| 115040925 | 11504092 | 5 | 20150907 | 20160130 | 0 | |
| 115040925 | 11504092 | 6 | 20160201 | 0 | ||
| 115040925 | 11504092 | 7 | 20150907 | 0 | ||
| 115040925 | 11504092 | 8 | 20151203 | 0 | ||
| 115040925 | 11504092 | 9 | 20061101 | 0 |