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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110686725 | 11068672 | 5 | F | 20140805 | 20160729 | 20150427 | 20160803 | EXP | JP-JNJFOC-20150414001 | JANSSEN | 72.22 | YR | E | M | Y | 61.00000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110686725 | 11068672 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 110686725 | 11068672 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 800 | MG | UNSPECIFIED | QD | ||||||
| 110686725 | 11068672 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 110686725 | 11068672 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 200 | MG | UNSPECIFIED | QD | ||||||
| 110686725 | 11068672 | 5 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 110686725 | 11068672 | 6 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | UNSPECIFIED | QD | ||||||
| 110686725 | 11068672 | 7 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 110686725 | 11068672 | 8 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | UNSPECIFIED | QD | ||||||
| 110686725 | 11068672 | 9 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .815 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 10 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.63 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 11 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.63 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 12 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .82 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 13 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.63 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 14 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .82 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 15 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .815 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 16 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.63 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 17 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.63 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 18 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .82 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 19 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.63 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 20 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .82 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 21 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.63 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 22 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.63 | UG/KG | INJECTION | /wk | ||||||
| 110686725 | 11068672 | 23 | C | FLUVASTATIN SODIUM. | FLUVASTATIN SODIUM | 1 | Oral | 0 | 30 | MG | UNSPECIFIED | QD | |||||||
| 110686725 | 11068672 | 24 | C | POLAPREZINC | POLAPREZINC | 1 | Oral | 0 | 150 | MG | UNSPECIFIED | QD | |||||||
| 110686725 | 11068672 | 25 | C | EPADEL-S | ICOSAPENT ETHYL | 1 | Unknown | 0 | 1800 | MG | UNSPECIFIED | QD | |||||||
| 110686725 | 11068672 | 26 | C | ETODOLAC. | ETODOLAC | 1 | Unknown | 0 | 200 | MG | UNSPECIFIED | ||||||||
| 110686725 | 11068672 | 27 | C | ARTIST | CARVEDILOL | 1 | Unknown | 0 | 10 | MG | UNSPECIFIED | QD | |||||||
| 110686725 | 11068672 | 28 | C | ATELEC | CILNIDIPINE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110686725 | 11068672 | 1 | Chronic hepatitis C |
| 110686725 | 11068672 | 2 | Chronic hepatitis C |
| 110686725 | 11068672 | 3 | Chronic hepatitis C |
| 110686725 | 11068672 | 4 | Chronic hepatitis C |
| 110686725 | 11068672 | 5 | Chronic hepatitis C |
| 110686725 | 11068672 | 6 | Chronic hepatitis C |
| 110686725 | 11068672 | 7 | Chronic hepatitis C |
| 110686725 | 11068672 | 8 | Chronic hepatitis C |
| 110686725 | 11068672 | 9 | Chronic hepatitis C |
| 110686725 | 11068672 | 10 | Chronic hepatitis C |
| 110686725 | 11068672 | 11 | Chronic hepatitis C |
| 110686725 | 11068672 | 12 | Chronic hepatitis C |
| 110686725 | 11068672 | 13 | Chronic hepatitis C |
| 110686725 | 11068672 | 14 | Chronic hepatitis C |
| 110686725 | 11068672 | 15 | Chronic hepatitis C |
| 110686725 | 11068672 | 16 | Chronic hepatitis C |
| 110686725 | 11068672 | 17 | Chronic hepatitis C |
| 110686725 | 11068672 | 18 | Chronic hepatitis C |
| 110686725 | 11068672 | 19 | Chronic hepatitis C |
| 110686725 | 11068672 | 20 | Chronic hepatitis C |
| 110686725 | 11068672 | 21 | Chronic hepatitis C |
| 110686725 | 11068672 | 22 | Chronic hepatitis C |
| 110686725 | 11068672 | 23 | Prophylaxis |
| 110686725 | 11068672 | 24 | Product used for unknown indication |
| 110686725 | 11068672 | 25 | Prophylaxis |
| 110686725 | 11068672 | 26 | Prophylaxis |
| 110686725 | 11068672 | 27 | Essential hypertension |
| 110686725 | 11068672 | 28 | Essential hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110686725 | 11068672 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110686725 | 11068672 | Blood bilirubin increased | |
| 110686725 | 11068672 | Decreased appetite | |
| 110686725 | 11068672 | Haemoglobin decreased | |
| 110686725 | 11068672 | Insomnia | |
| 110686725 | 11068672 | Platelet count decreased | |
| 110686725 | 11068672 | Pruritus | |
| 110686725 | 11068672 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 110686725 | 11068672 | 1 | 20140805 | 20141027 | 0 | |
| 110686725 | 11068672 | 2 | 20140805 | 20140901 | 0 | |
| 110686725 | 11068672 | 3 | 20140902 | 20140908 | 0 | |
| 110686725 | 11068672 | 4 | 20140909 | 20140923 | 0 | |
| 110686725 | 11068672 | 5 | 20140924 | 20140929 | 0 | |
| 110686725 | 11068672 | 6 | 20140930 | 20141020 | 0 | |
| 110686725 | 11068672 | 7 | 20141021 | 20150105 | 0 | |
| 110686725 | 11068672 | 8 | 20150106 | 20150120 | 0 | |
| 110686725 | 11068672 | 9 | 20141209 | 20141216 | 0 | |
| 110686725 | 11068672 | 10 | 20141223 | 20150113 | 0 | |
| 110686725 | 11068672 | 11 | 20140805 | 20140902 | 0 | |
| 110686725 | 11068672 | 12 | 20140909 | 20140916 | 0 | |
| 110686725 | 11068672 | 13 | 20140922 | 20140930 | 0 | |
| 110686725 | 11068672 | 14 | 20141007 | 20141007 | 0 | |
| 110686725 | 11068672 | 15 | 20141209 | 20141216 | 0 | |
| 110686725 | 11068672 | 16 | 20141223 | 20150113 | 0 | |
| 110686725 | 11068672 | 17 | 20141015 | 20141202 | 0 | |
| 110686725 | 11068672 | 18 | 20141007 | 20141007 | 0 | |
| 110686725 | 11068672 | 19 | 20140922 | 20140930 | 0 | |
| 110686725 | 11068672 | 20 | 20140909 | 20140916 | 0 | |
| 110686725 | 11068672 | 21 | 20140805 | 20140902 | 0 | |
| 110686725 | 11068672 | 22 | 20141015 | 20141202 | 0 | |
| 110686725 | 11068672 | 23 | 20140805 | 20150120 | 0 | |
| 110686725 | 11068672 | 24 | 20140805 | 20150120 | 0 | |
| 110686725 | 11068672 | 25 | 20140805 | 20150120 | 0 | |
| 110686725 | 11068672 | 26 | 20140804 | 20150210 | 0 |