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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125203452 | 12520345 | 2 | F | 2012 | 20160819 | 20160701 | 20160823 | EXP | PL-ROCHE-1784927 | ROCHE | 49.00 | YR | M | Y | 0.00000 | 20160823 | MD | PL | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125203452 | 12520345 | 1 | PS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | U | 103964 | 180 | UG | /wk | |||||||
| 125203452 | 12520345 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | U | 21511 | ||||||||||
| 125203452 | 12520345 | 3 | SS | Peg-Interferon Alfa 2a | PEGINTERFERON ALFA-2A | 1 | Unknown | U | 103964 | ||||||||||
| 125203452 | 12520345 | 4 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 1200 MG A DAY | U | 21511 | 1200 | MG | QD | ||||||
| 125203452 | 12520345 | 5 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG A DAY | U | 0 | 400 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125203452 | 12520345 | 1 | Hepatitis C |
| 125203452 | 12520345 | 2 | Product used for unknown indication |
| 125203452 | 12520345 | 3 | Product used for unknown indication |
| 125203452 | 12520345 | 4 | Hepatitis C |
| 125203452 | 12520345 | 5 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125203452 | 12520345 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125203452 | 12520345 | Anaemia | |
| 125203452 | 12520345 | Aspartate aminotransferase increased | |
| 125203452 | 12520345 | Basophil count increased | |
| 125203452 | 12520345 | Blood bilirubin increased | |
| 125203452 | 12520345 | Eosinophil count increased | |
| 125203452 | 12520345 | Gamma-glutamyltransferase increased | |
| 125203452 | 12520345 | Haematocrit decreased | |
| 125203452 | 12520345 | Haemoglobin decreased | |
| 125203452 | 12520345 | Hepatitis C | |
| 125203452 | 12520345 | Leukopenia | |
| 125203452 | 12520345 | Lymphocyte count decreased | |
| 125203452 | 12520345 | Monocyte count increased | |
| 125203452 | 12520345 | Neutrophil count decreased | |
| 125203452 | 12520345 | Platelet count decreased | |
| 125203452 | 12520345 | Platelet count increased | |
| 125203452 | 12520345 | Red blood cell count decreased | |
| 125203452 | 12520345 | Red cell distribution width increased | |
| 125203452 | 12520345 | 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 |
|---|---|---|---|---|---|---|
| 125203452 | 12520345 | 1 | 20160324 | 0 | ||
| 125203452 | 12520345 | 2 | 2012 | 0 | ||
| 125203452 | 12520345 | 3 | 2012 | 0 | ||
| 125203452 | 12520345 | 4 | 20160324 | 0 | ||
| 125203452 | 12520345 | 5 | 20160324 | 0 |