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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126113501 | 12611350 | 1 | I | 20151201 | 20160725 | 20160801 | 20160801 | EXP | US-BAUSCH-BL-2016-017920 | BAUSCH AND LOMB | 61.76 | YR | F | Y | 0.00000 | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126113501 | 12611350 | 1 | PS | XIFAXAN | RIFAXIMIN | 1 | Oral | U | 21361 | 550 | MG | TABLET | BID | ||||||
| 126113501 | 12611350 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | U | 18859 | ||||||||||
| 126113501 | 12611350 | 3 | I | OLYSIO | SIMEPREVIR | 1 | Unknown | U | 0 | ||||||||||
| 126113501 | 12611350 | 4 | SS | SOVALDI | SOFOSBUVIR | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126113501 | 12611350 | 1 | Hepatic encephalopathy |
| 126113501 | 12611350 | 2 | Hepatitis C |
| 126113501 | 12611350 | 3 | Hepatitis C |
| 126113501 | 12611350 | 4 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126113501 | 12611350 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126113501 | 12611350 | Arrhythmia | |
| 126113501 | 12611350 | Bone abscess | |
| 126113501 | 12611350 | Cardiac disorder | |
| 126113501 | 12611350 | Chest pain | |
| 126113501 | 12611350 | Drug interaction | |
| 126113501 | 12611350 | Guillain-Barre syndrome | |
| 126113501 | 12611350 | Herpes zoster | |
| 126113501 | 12611350 | Immunosuppression | |
| 126113501 | 12611350 | Infection | |
| 126113501 | 12611350 | Injury | |
| 126113501 | 12611350 | Loss of consciousness | |
| 126113501 | 12611350 | Malaise | |
| 126113501 | 12611350 | Memory impairment | |
| 126113501 | 12611350 | Pyrexia | |
| 126113501 | 12611350 | Skin infection | |
| 126113501 | 12611350 | Stress |
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 |
|---|---|---|---|---|---|---|
| 126113501 | 12611350 | 1 | 2014 | 201512 | 0 | |
| 126113501 | 12611350 | 2 | 201405 | 20141007 | 0 | |
| 126113501 | 12611350 | 3 | 201405 | 20141007 | 0 | |
| 126113501 | 12611350 | 4 | 201405 | 20141007 | 0 |