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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109461686 | 10946168 | 6 | F | 20140409 | 20160809 | 20150323 | 20160823 | EXP | JP-JNJFOC-20150311219 | JANSSEN | 63.60 | YR | A | M | Y | 62.00000 | KG | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109461686 | 10946168 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 109461686 | 10946168 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 0 | 800 | MG | UNSPECIFIED | QD | |||||||
| 109461686 | 10946168 | 3 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 1 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 4 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 1 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 5 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | .8 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 6 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 180 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 7 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 1 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 8 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | .8 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 9 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 1 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 10 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .8 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 11 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 12 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 13 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .8 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 14 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1 | UG/KG | INJECTION | /wk | ||||||
| 109461686 | 10946168 | 15 | C | URSO | URSODIOL | 1 | Oral | 0 | 600 | MG | UNSPECIFIED | QD | |||||||
| 109461686 | 10946168 | 16 | C | BASEN | VOGLIBOSE | 1 | Oral | 0 | .6 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109461686 | 10946168 | 1 | Chronic hepatitis C |
| 109461686 | 10946168 | 2 | Chronic hepatitis C |
| 109461686 | 10946168 | 3 | Chronic hepatitis C |
| 109461686 | 10946168 | 4 | Chronic hepatitis C |
| 109461686 | 10946168 | 5 | Chronic hepatitis C |
| 109461686 | 10946168 | 6 | Chronic hepatitis C |
| 109461686 | 10946168 | 7 | Chronic hepatitis C |
| 109461686 | 10946168 | 8 | Chronic hepatitis C |
| 109461686 | 10946168 | 9 | Chronic hepatitis C |
| 109461686 | 10946168 | 10 | Chronic hepatitis C |
| 109461686 | 10946168 | 11 | Chronic hepatitis C |
| 109461686 | 10946168 | 12 | Chronic hepatitis C |
| 109461686 | 10946168 | 13 | Chronic hepatitis C |
| 109461686 | 10946168 | 14 | Chronic hepatitis C |
| 109461686 | 10946168 | 15 | Chronic hepatitis C |
| 109461686 | 10946168 | 16 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109461686 | 10946168 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109461686 | 10946168 | Anaemia | |
| 109461686 | 10946168 | Dermatitis atopic | |
| 109461686 | 10946168 | Erythema | |
| 109461686 | 10946168 | Platelet 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 |
|---|---|---|---|---|---|---|
| 109461686 | 10946168 | 1 | 20140409 | 20140629 | 0 | |
| 109461686 | 10946168 | 2 | 20140409 | 20140922 | 0 | |
| 109461686 | 10946168 | 3 | 20140616 | 20140916 | 0 | |
| 109461686 | 10946168 | 4 | 20140416 | 20140526 | 0 | |
| 109461686 | 10946168 | 5 | 20140602 | 20140609 | 0 | |
| 109461686 | 10946168 | 6 | 20140409 | 20140409 | 0 | |
| 109461686 | 10946168 | 7 | 20140416 | 20140526 | 0 | |
| 109461686 | 10946168 | 8 | 20140602 | 20140609 | 0 | |
| 109461686 | 10946168 | 9 | 20140616 | 20140916 | 0 | |
| 109461686 | 10946168 | 10 | 20140602 | 20140609 | 0 | |
| 109461686 | 10946168 | 11 | 20140416 | 20140526 | 0 | |
| 109461686 | 10946168 | 12 | 20140616 | 0 | ||
| 109461686 | 10946168 | 13 | 20140602 | 20140609 | 0 | |
| 109461686 | 10946168 | 14 | 20140416 | 20140526 | 0 |