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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111524485 | 11152448 | 5 | F | 20140224 | 20160824 | 20150601 | 20160831 | EXP | JP-JNJFOC-20140313401 | JANSSEN | 37.00 | YR | A | M | Y | 62.00000 | KG | 20160831 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111524485 | 11152448 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Unknown | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 111524485 | 11152448 | 2 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .75 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 3 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 4 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .75 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 5 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 6 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .75 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 7 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 8 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .75 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 9 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 10 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 11 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .75 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 12 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 13 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .75 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 14 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 15 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .75 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 16 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .75 | UG/KG | INJECTION | /wk | ||||||
| 111524485 | 11152448 | 17 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 0 | 800 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111524485 | 11152448 | 1 | Chronic hepatitis C |
| 111524485 | 11152448 | 2 | Chronic hepatitis C |
| 111524485 | 11152448 | 3 | Chronic hepatitis C |
| 111524485 | 11152448 | 4 | Chronic hepatitis C |
| 111524485 | 11152448 | 5 | Chronic hepatitis C |
| 111524485 | 11152448 | 6 | Chronic hepatitis C |
| 111524485 | 11152448 | 7 | Chronic hepatitis C |
| 111524485 | 11152448 | 8 | Chronic hepatitis C |
| 111524485 | 11152448 | 9 | Chronic hepatitis C |
| 111524485 | 11152448 | 10 | Chronic hepatitis C |
| 111524485 | 11152448 | 11 | Chronic hepatitis C |
| 111524485 | 11152448 | 12 | Chronic hepatitis C |
| 111524485 | 11152448 | 13 | Chronic hepatitis C |
| 111524485 | 11152448 | 14 | Chronic hepatitis C |
| 111524485 | 11152448 | 15 | Chronic hepatitis C |
| 111524485 | 11152448 | 16 | Chronic hepatitis C |
| 111524485 | 11152448 | 17 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111524485 | 11152448 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111524485 | 11152448 | Neutrophil count decreased | |
| 111524485 | 11152448 | Pharyngitis |
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 |
|---|---|---|---|---|---|---|
| 111524485 | 11152448 | 1 | 20140218 | 20140512 | 0 | |
| 111524485 | 11152448 | 2 | 20140224 | 20140224 | 0 | |
| 111524485 | 11152448 | 3 | 20140303 | 20140324 | 0 | |
| 111524485 | 11152448 | 4 | 20140331 | 20140331 | 0 | |
| 111524485 | 11152448 | 5 | 20140407 | 20140407 | 0 | |
| 111524485 | 11152448 | 6 | 20140414 | 20140414 | 0 | |
| 111524485 | 11152448 | 7 | 20140421 | 20140421 | 0 | |
| 111524485 | 11152448 | 8 | 20140428 | 20140729 | 0 | |
| 111524485 | 11152448 | 9 | 20140218 | 20140218 | 0 | |
| 111524485 | 11152448 | 10 | 20140303 | 20140324 | 0 | |
| 111524485 | 11152448 | 11 | 20140331 | 20140331 | 0 | |
| 111524485 | 11152448 | 12 | 20140407 | 20140407 | 0 | |
| 111524485 | 11152448 | 13 | 20140414 | 20140414 | 0 | |
| 111524485 | 11152448 | 14 | 20140421 | 20140421 | 0 | |
| 111524485 | 11152448 | 15 | 20140428 | 20140729 | 0 | |
| 111524485 | 11152448 | 16 | 20140224 | 20140224 | 0 | |
| 111524485 | 11152448 | 17 | 20140218 | 20140804 | 0 |