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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112793002 | 11279300 | 2 | F | 20150316 | 20160819 | 20150717 | 20160824 | EXP | JP-JNJFOC-20150707910 | JANSSEN | 68.91 | YR | E | F | Y | 49.00000 | KG | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112793002 | 11279300 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 112793002 | 11279300 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | N | 0 | 300 | MG | UNSPECIFIED | QD | ||||||
| 112793002 | 11279300 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | N | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 112793002 | 11279300 | 4 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | N | 0 | .6 | UG/KG | INJECTION | /wk | ||||||
| 112793002 | 11279300 | 5 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | N | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 112793002 | 11279300 | 6 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | N | 0 | 1.2 | UG/KG | INJECTION | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112793002 | 11279300 | 1 | Chronic hepatitis C |
| 112793002 | 11279300 | 2 | Chronic hepatitis C |
| 112793002 | 11279300 | 3 | Chronic hepatitis C |
| 112793002 | 11279300 | 4 | Chronic hepatitis C |
| 112793002 | 11279300 | 5 | Chronic hepatitis C |
| 112793002 | 11279300 | 6 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112793002 | 11279300 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112793002 | 11279300 | Haemoglobin decreased | |
| 112793002 | 11279300 | 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 |
|---|---|---|---|---|---|---|
| 112793002 | 11279300 | 1 | 20150310 | 20150601 | 0 | |
| 112793002 | 11279300 | 2 | 20150420 | 20150823 | 0 | |
| 112793002 | 11279300 | 3 | 20150310 | 20150419 | 0 | |
| 112793002 | 11279300 | 4 | 2015 | 20150823 | 0 | |
| 112793002 | 11279300 | 5 | 20150310 | 20150310 | 0 | |
| 112793002 | 11279300 | 6 | 20150316 | 2015 | 0 |