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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125478201 | 12547820 | 1 | I | 20150729 | 20150820 | 20160712 | 20160712 | EXP | JP-ROCHE-1625095 | ROCHE | 80.00 | YR | F | Y | 51.00000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125478201 | 12547820 | 1 | PS | COPEGUS | RIBAVIRIN | 1 | Oral | Y | 21511 | 600 | MG | TABLET | QD | ||||||
| 125478201 | 12547820 | 2 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Unknown | Y | 103964 | ||||||||||
| 125478201 | 12547820 | 3 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | Y | 0 | 400 | MG | TABLET | QD | ||||||
| 125478201 | 12547820 | 4 | C | AMLODIN | AMLODIPINE BESYLATE | 1 | Oral | DOSAGE IS UNCERTAIN. | 0 | TABLET | |||||||||
| 125478201 | 12547820 | 5 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 125478201 | 12547820 | 6 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Unknown | DOSAGE IS UNCERTAIN. | 0 | ||||||||||
| 125478201 | 12547820 | 7 | C | OLOPATADINE HYDROCHLORIDE. | OLOPATADINE HYDROCHLORIDE | 1 | Oral | DOSAGE IS UNCERTAIN. | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125478201 | 12547820 | 1 | Chronic hepatitis C |
| 125478201 | 12547820 | 2 | Product used for unknown indication |
| 125478201 | 12547820 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125478201 | 12547820 | OT |
| 125478201 | 12547820 | LT |
| 125478201 | 12547820 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125478201 | 12547820 | Cerebral infarction | |
| 125478201 | 12547820 | Dehydration | |
| 125478201 | 12547820 | Drug ineffective | |
| 125478201 | 12547820 | Hepatitis | |
| 125478201 | 12547820 | Hepatocellular carcinoma |
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 |
|---|---|---|---|---|---|---|
| 125478201 | 12547820 | 1 | 20150701 | 20150803 | 0 | |
| 125478201 | 12547820 | 2 | 20150113 | 20150530 | 0 | |
| 125478201 | 12547820 | 3 | 20150701 | 20150803 | 0 | |
| 125478201 | 12547820 | 4 | 20150829 | 0 | ||
| 125478201 | 12547820 | 5 | 20150829 | 0 | ||
| 125478201 | 12547820 | 6 | 20150829 | 0 | ||
| 125478201 | 12547820 | 7 | 20150829 | 0 |